31 replies to this topic

[unregistered_user]

I have always wanted to try Modafinil but have been trepidatious due to the possibility of the severe dematological reactions (see wiki) such as SJS and TEN.

To the people here who have tried Modafinil, what have your experiences been like and how did you manage to get yourself past obsessing over the risks of a severe adverse reaction? Percentage wise, what kind of risk are we talking about here? Am I more likely to get struck by lightening? Is my risk for developing SJS just as likely as if I were to take an Aspirin or Ginseng?

In our quest for enhanced cognition, we subject ourselves to uncertainties and risks. I know this is a subjective question but I will pose it in order to gain perspective. For you, is the risk to benefit analysis worth it or not? Would you endeavor to try Modafinil knowing that potential (albeit quite unlikely) side-effects exist?

[maxwatt]

From your wikipedia link:

From the date of initial marketing, December 1998, to January 30, 2007, FDA received six cases of severe cutaneous adverse reactions associated with modafinil, including erythema multiforme (EM), Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) involving adult and pediatric patients. The FDA issued a relevant alert. In the same alert, the FDA also noted that angioedema and multi-organ hypersensitivity reactions have also been reported in postmarketing experience.[83

six out of how many thousands and thousand who have used modafinal? I would say the reactions are probably due to chance, not to the the supplement/medicine/drug.

[Junk Master]

Not likely. Though I do have drier skin when using modafinil. I'd be more concerned with chronic dehydration.

[Valor5]

I have never tried modafinil. I did have some labs done recently but I don't know that they checked my immune system stuff. The reason I am cautious is because even though I do not suffer from allergies or have allergies to most things my mom has either osteo or rheumatoid arthritis. Her hands are not terribly deformed but some joints are stuck and I think I am going to inherit that down the line. But if any of these autoimmune diseases run in your family or you have expressed them I think it would be wise to proceed with extreme caution.

Recent evidence is supportive of a role for inflammatory cytokines and the death receptor Fas and its ligand FasL in the pathogenesis of keratinocyte apoptosis during TEN. This Fas-mediated keratinocyte apoptosis that is the last step culminating in epidermal detachment in TEN can be inhibited in vitro by antagonistic monoclonal antibodies to Fas, and by intravenous immunoglobulins (IVIG) which have been shown to contain natural anti-Fas antibodies. Consequently, over the last few years, numerous case reports and 9 non-controlled clinical studies containing 10 or more patients have analyzed the therapeutic effect of IVIG in TEN. Taken together, although each study has its potential biases, 7 of 9 such studies point towards a benefit of IVIG used at doses greater than 2 g/kg on the mortality associated with TEN. These studies should serve as the basis for designing an appropriate prospective trial or for conducting a metaanalysis in the near future, in order to determine the therapeutic efficacy of IVIG in TEN.

We have provided further evidence that TNF-alpha is strongly expressed in SJS/TEN lesions and therefore it may be involved in the epidermal necrosis featured in such diseases. IFN-gamma may play an important role both in EM and SJS/TEN. IL-2, IL-5 and IL-13 may contribute to the cutaneous immunoinflammation in these diseases. Chemokine receptors may be involved strongly in the recruitment of inflammatory cells in lesional skin. In our cases we found a sharp polarization towards a Th1 pattern in EM, while the SJS/TEN lesions showed a mixed Th1/Th2 pattern.

TNF-alpha inhibitors:

From Wikipedia

This inhibition can be achieved with a monoclonal antibody such as infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), and golimumab (Simponi), or with a circulating receptor fusion protein such as etanercept (Enbrel).
While most clinically useful TNF inhibitors are monoclonal antibodies, some are simple molecules such as xanthine derivatives ^[4] (e.g. pentoxifylline ^[5]) and Bupropion.^[6] Bupropion is the active ingredient in the smoking cessation aid Zyban and the antidepressant Wellbutrin.
Several 5-HT_2A agonist hallucinogens including ®-DOI, TCB-2, LSD and LA-SS-Az have unexpectedly also been found to act as potent inhibitors of TNFα, with DOI being the most active, showing TNFα inhibition in the picomolar range, an order of magnitude more potent than its action as a hallucinogen.^[7][8][9]

Starting TNF inhibition puts patients at increased risk of opportunistic infections... People taking TNFα blockers are at increased risk for developing serious infections that may lead to hospitalization or death due to bacterial(TUBERCULOSIS), mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.^[20]

Anti-TNF agents in nature
TNF or the effects of TNF are also inhibited by a number of natural compounds, including curcumin^{[23][24][25][26]} (a compound present in turmeric), and catechins (in green tea). Also activation of cannabinoid CB1 or CB2 receptors by cannabis or Echinacea purpurea seem to have anti-inflammatory properties through TNF-alpha inhibition.^[27]

Edited by valory5, 03 April 2012 - 09:16 AM.

[jadamgo]

I have to admit, your concerns seem more founded on uncontrolled worry than on science. Lots of medications carry a very low risk of SJS, like modafinil. They can't be prescribed if they cause it frequently. Drugs have been taken off the market for that sort of thing, within only a few years of availability. If modafinil was causing too much SJS, it would have been pulled a long time ago.

Here's how you would handle that risk if you took modafinil: If you get a rash, stop taking it and go to the ER. Way most of the time, the rash is NOT SJS. It's just a simple, run-of-the-mill allergic reaction that will go away with a bit of over-the-counter hydrocortisone cream, or perhaps some benadryl. If you happen to be the 1 out of thousands who gets SJS, then you'll have saved yourself by following the advice. If you catch SJS early on, you can fix it.

[Valor5]

I have to admit, your concerns seem more founded on uncontrolled worry than on science. Lots of medications carry a very low risk of SJS, like modafinil. They can't be prescribed if they cause it frequently. Drugs have been taken off the market for that sort of thing, within only a few years of availability. If modafinil was causing too much SJS, it would have been pulled a long time ago.

Here's how you would handle that risk if you took modafinil: If you get a rash, stop taking it and go to the ER. Way most of the time, the rash is NOT SJS. It's just a simple, run-of-the-mill allergic reaction that will go away with a bit of over-the-counter hydrocortisone cream, or perhaps some benadryl. If you happen to be the 1 out of thousands who gets SJS, then you'll have saved yourself by following the advice. If you catch SJS early on, you can fix it.

You are certainly wrong. All my statements are scientific. I understand that the risk may be low however if one is predisposed then it would be highly stupid to go at it carelessly. You can run your ship the way you want but mine is too precious to treat it with little thought.

[Raptor87]

The drug that induced SJS was Sparlon (Modafinil for ADHD) which means that it was in much higher dosages than the regular brand Modafinil. Also there is no clear data on that it was Modafinil that caused the skin alteration.

From:
http://www.fda.gov/o...09-FDA-Tab9.pdf

In all clinical trials, among a total of 933 children diagnosed
with ADHD and treated with SPARLON, 11 (1.1%) developed rashes or other possible
skin/mucous membrane-associated reactions that resulted in hospitalizations and/or
discontinuation from treatment. In no reported cases were skin reactions fatal. Two cases were
consistent with a possible diagnosis of Stevens-Johnson Syndrome (SJS) that manifested as skin
blistering and/or mucous membrane involvement (although 1 case was confounded by alternative
infectious/drug etiologies). Neither of these patients was hospitalized. In both cases, the events
resolved following discontinuation of study drug. No biopsy-confirmed cases of SJS were
reported. Modafinil treatment should be discontinued in patients developing serious rash.

Keep in mind that adverse skin reactions also happened in the placebo- control group when Sparlon was on trial. I say you can keep your head cool about this matter.

Edited by Brainfogged, 05 April 2012 - 07:21 PM.

[unregistered_user]

Thanks everyone. I do have some Modalert on order from mymodafinil.com. Should be here in a week.

Anyone else have any thoughts? If you had a 30 day supply of 200mg tablets in front of you, in light of possible side effects, would you try it out?

[unregistered_user]

After a few days of research I have learned that SJS is NOT as rare as the literature suggestions. In fact, it seems to be a lot more common than I originally thought. Nothing scientific to back up this feeling other than hours of Google searching reading forum posts, articles, etc.

Considering the nature of SJS, the lack of effective care and the delayed onset (meaning, I could take modafinil every day for 2 weeks thinking I'm fine before I wind up with rashes and ulcers) I think I will take a pass.

[Raptor87]

After a few days of research I have learned that SJS is NOT as rare as the literature suggestions. In fact, it seems to be a lot more common than I originally thought. Nothing scientific to back up this feeling other than hours of Google searching reading forum posts, articles, etc.

Considering the nature of SJS, the lack of effective care and the delayed onset (meaning, I could take modafinil every day for 2 weeks thinking I'm fine before I wind up with rashes and ulcers) I think I will take a pass.

Could you please refer to the science that you mention. As for what I know, there are no evidence that suggests that it is Modafinil that causes SJS.

[Raptor87]

The drug that induced SJS was Sparlon (Modafinil for ADHD) which means that it was in much higher dosages than the regular brand Modafinil. Also there is no clear data on that it was Modafinil that caused the skin alteration.

From:
http://www.fda.gov/o...09-FDA-Tab9.pdf

In all clinical trials, among a total of 933 children diagnosed
with ADHD and treated with SPARLON, 11 (1.1%) developed rashes or other possible
skin/mucous membrane-associated reactions that resulted in hospitalizations and/or
discontinuation from treatment. In no reported cases were skin reactions fatal. Two cases were
consistent with a possible diagnosis of Stevens-Johnson Syndrome (SJS) that manifested as skin
blistering and/or mucous membrane involvement (although 1 case was confounded by alternative
infectious/drug etiologies). Neither of these patients was hospitalized. In both cases, the events
resolved following discontinuation of study drug. No biopsy-confirmed cases of SJS were
reported. Modafinil treatment should be discontinued in patients developing serious rash.

Keep in mind that adverse skin reactions also happened in the placebo- control group when Sparlon was on trial. I say you can keep your head cool about this matter.

http://www.modafinil.com/

I investigated 1/1000th (SJS) case even further.

In August 2006 Cephalon unexpectedly received a 'non-approvable' letter from the FDA for modafinil tablets branded as Sparlon. Taken in this guise, modafinil was intended for the treatment of so-called attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. The FDA's rejection of modafinil/Sparlon for ADHD was based on a single adverse incident during clinical trials. One child developed a rash suggestive of Stevens-Johnson syndrome - a serious hypersensitivity complex affecting the skin and mucous membranes. There is no evidence that Stevens-Johnson syndrome is more common in adult modafinil users. The physician who diagnosed SJS in the affected 10 year old later recanted the diagnosis. Meanwhile, millions of lively American school students controversially diagnosed with ADHD continue to be prescribed toxic amphetamine-based products instead.

If you ordered Modafinil then there is no reason not to take it, if you don´t suffer from psychological problems or may have issues which is mentioned in the warning label. I have been eating modafinil for 5 years and haven´t sensed any adverse skin problems, well except those caused by fatigue. Sure I get a itch from time to time but it is due to increased sweating, vasolidation and excess derma- tissue capillary circulation. I think there is a possible metabolisation of Modafinil through sweating, which means that there is a crystallization of Modafinil through the derma on to the skin surface which may be the reason for the itch. But I am not sure of it. I am still trying to find evidence for it.

I also itch when I keep myself up for a long time, drug or no drug. Don´t really know why this happens but It´s probably because the surface tissue cant regenerate itself and the skin dies and becomes all flaky. We need our sleep so the body can keep up!

If you have bought Modafinil then there is no reason not to take it for it´s purpose or to panic if you start itching.

[noos]

Brainfogged do you tale it daily? Dose? Thanks

Edited by noos, 06 April 2012 - 09:04 PM.

[unregistered_user]

Brainfogged,

I said I don't have any science to back up my feelings, but after extensive searching I've become uneasy with Modafinil for the following reasons.

First, the symptoms of SJS are benign in the beginning. They are: fever, sore throat, cough, and eye pain. This is worrisome because while I'm taking Modafinil, how will I ever know if I've picked up a cold, a flu bug, or am developing SJS? It's like I can't simply chalk up my cough or sore throat to anything run-of-the-mill without risking overlooking a potentially fatal condition. It's hard to live like that. Additionally, Modafinil is prone to giving users rashes anyway. Sometimes the rash is simply an allergic reaction that can be taken care of with some hydrocortisone cream but how will you ever know? Again, not taking a Modafinil rash seriously and dismissing it as an allergic reaction could end in devastation. Basically every minor symptom needs to be treated with the utmost seriousness.

Also, your claim that the only drug that induced SJS is Sparlon is challenged by the following FDA Safety Alerts. The FDA apparently feels issuing an alert for PROVIGIL is warranted.

Provigil (modafinil) Tablets

Audience: Neuropsychiatric specialists, other healthcare professionals, consumers

[Posted 10/24/2007] FDA and Cephalon notified healthcare professionals of updates to the WARNINGS section of the prescribing information for Provigil (modafinil). Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. The revised labeling updates safety information to include warnings regarding serious rash, including Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions, and psychiatric symptoms. Rare cases of serious or life-threatening rash, including Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms have been reported in adults and children in worldwide postmarketing experience. Angioedema and multi-organ hypersensitivity reactions have also been reported in postmarketing experience.

Physicians should instruct their patients to immediately discontinue the use of Provigil and contact them if a rash or other hypersensitivity reaction occurs. Healthcare professionals and consumers should also be aware that Provigil is not approved for use in pediatric patients for any indication. In addition, psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidal ideation) have been reported in patients treated with Provigil. Caution should be exercised when Provigil is given to patients with a history of psychosis, depression, or mania.

Additional labeling revisions were made to the CLINICAL PHARMACOLOGY, PRECAUTIONS, and PATIENT PACKAGE INSERT sections. See revised labeling below.

[September 2007 - Dear Healthcare Professional Letter - Cephalon]
[August 2007 - Label - Cephalon]

Here is another Safety Alert issued by the FDA regarding Provigil/Modafinil in relation to SJS.

FDA has been monitoring cases of serious skin reactions, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), in its postmarketing reviews of adverse event reports associated with the use of modafinil. The product labeling for modafinil has been recently updated to include a bolded warning for serious rash, including SJS.¹ Based on postmarketing data for modafinil, a recently approved drug with a similar chemical structure, armodafinil, includes a similar bolded warning in the product labeling.² Healthcare professionals and patients should be watchful for skin reactions associated with the use of modafinil and armodafinil and report cases to FDA's MedWatch.

Modafinil (Provigil) is an oral wakefulness-promoting agent to treat patients with excessive sleepiness (ES) associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder (SWSD).¹ Modafinil is a controlled substance (C-IV) and has been available in the United States since 1998. The safety and efficacy in children under the age of 16 has not been established.

From the date of initial marketing, December 1998, to January 30, 2007, FDA received six cases of severe cutaneous adverse reactions associated with modafinil, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) involving adult and pediatric patients.

The 6 cases from the United States occurred in four females and two males aged 49, 42, 17, 27, 15, and 7 years old, respectively. The median time-to-onset of adverse dermatologic effects following initiation of modafinil therapy was 17.5 days, ranging from 5 days to 5 weeks (see Table). Patients presented with a rash to either body extremities (arms, hands, and legs) or to the whole body with some experiencing eruptions in the mouth (lips, tongue), eyes, or genitals. In addition, some patients developed skin pigment changes, pruritus, ulcers, burning of the skin, mild skin scaling, sloughing, and/or fever. Skin biopsies from four patients confirmed TEN, SJS/TEN, SJS/EM, and eosinophilia with unspecified findings consistent with a drug hypersensitivity syndrome.^3,4

There were no deaths. Five of 6 patients required hospital admission for management, including one patient with TEN who was admitted to the surgical burn unit 20 days after starting modafinil at recommended doses to treat a sleep disorder. In this case, the rash affected 50% of the total body surface area (BSA), with 20 to 30% of the skin denuded. Although this patient had an extensive medication history, modafinil was the primary suspect drug because it was the last agent added to the patient's drug regimen. In addition, modafinil discontinuation upon hospital admission coincided with patient improvement, despite continuation of other concomitant medications, such as celecoxib and propranolol, which have labeled warnings for TEN.

In one case of SJS, although potentially confounded with Lamictal therapy (labeled warning for SJS), rechallenge with modafinil resulted in recurrence of the rash including oral mucosal involvement, which supported a causal association with modafinil use. Modafinil was subsequently discontinued. In the SJS/TEN case, a 42-year-old female received concomitant medications (including escitalopram, which has a labeled warning for TEN) since 2005 without incidence before adding modafinil for sleep disorder in 2006. The patient's extensive body rash (30% of the body surface area), skin biopsy, and clinical presentation all aided the dermatologist in diagnosing SJS with overlapping TEN.

One case of DRESS syndrome was reported in a 15-year-old who was started on modafinil for attention deficit hyperactivity disorder (ADHD), an unapproved indication. After 5 weeks of therapy, the patient developed a skin rash that progressed with multiple organ system involvement, including the cardiac, renal, respiratory, and pancreatic systems. Based on the clinical presentation, increased eosinophil count, and skin biopsy results, the consulting dermatologist diagnosed DRESS syndrome.

Although some cases were potentially confounded by drugs known to be associated with serious skin reactions, all cases had features that implicate modafinil. The cases described a temporal relationship with detailed clinical descriptions, relevant laboratory data, dermatologist-substantiated diagnoses, skin biopsy confirmation, positive dechallenges, and/or a positive rechallenge, all of which support an association between modafinil use and serious cutaneous skin reactions.

The above shows at least 6 people who developed serious and potentially fatal rashes from PROVIGIL/MODAFINL... not Sparlon. See the full Safety Newsletter here.

I will include a few comments related to Provigil and SJS/TEN I found scouring the net.

PROVIGIL KILLS! I had "multi-organ" failures which NEARLY killed me after I started taking Provigil modafinil & a week after my dosage raised from 100 mg per day to 400 mg. What "failed" were my heart, my kidneys & my brain. My blood pressure sunk so low ( 80/45 ) that my brain & body got starved of oxygen. I was in cardiogenic shock, near death during a 9-day coma, spent 21 days in ICU, 32 days total in hospital. My heart, kidneys & brain were damaged permanently. DO NOT TAKE PROVIGIL!

Shane. : 2009-01-29 15:19:05

This drug can lead to very bad side effects, I should know. I have narcolepsy and started taking it. I felt great for 2 months and then it hit me. I got very, very depressed, stopped eating and started getting sores in my mouth, nose and on my lips. My tounge went numb and I couldn't eat right. All this after 2 months of being fine. If you do not have to take this then don't.... you are stupid!

Bruce Alan. : 2009-02-01 15:12:26

Shane, what you were experiencing was an apparently mild case of Stevens-Johnson Syndrome, on of at least a half dozen hypersensitivity syndromes which it somehow took the FDA 9 years to determine. SJS is a drug reaction so dangerous that severe cases can lead to death, even after hospitalized. Normally SJS is associated with skin rashes but it can cause mouth sores such as you describe as well as eye problems.
About 2 months after I began taking this dangerous medication I awoke one day in a state of complete delerium and ended up with (then) inexplicable acute kidney failure, heart failure and shock -- but no heart attack per se. This drug caused my whole body to become underperfused with blood due to lung failure. One eye heart and my mouth was sore too, but the MDs attributed that to a dental problem and didn't want to be bother. I survived only because I spent 9 days on a mechanical ventilator in a comatosw state before I regained consciousness. I spent 16 days in the ICU, 23 total in hospital and have been told that I overcame 1/250 odds in surviving. You should stop taking Provigil if you haven't already and NEVER, NEVER take Provigil again because your body has now been fully sensitized. Whoever the doctor was who told this writer it was a safe drug was reading from outdaated literature. I had my Provigil hell in January 2007. In the late part of 2007, the FDA for the first time released this information although they were aware of it in 2005. They required Cephalon, Provgil's maker, to include in BOLD print warnings about these hypersensitivity reactions. In 2006 the FDA refused to permit Provigil (under the alias 'Sparlon' to be marketed for use on ADHD ADD because the FDA committee thought that the occasion of just ONE case of Stevens-Johnson syndrome such as you had was deemed sufficient reason to deny approval.
Using Provigil for a legit purpose is bad enough; taking Provigil for 'fun' just might make it the last fun you will ever have. This drug has killed others and it CAN KILL YOU TOO. Dexedrine, Adderall and the other stimulants are far safer, both therapeutically and, if you must, for fun.

Provigil works wonderful for me with only one problem. On my second day taking 200mg of Provigil for narcolepsy I noticed a rash on my left hip and under my right arm and around to my back. The rash was not bad, just a slightly itchy red patch with small red bumps. I waited a month and tried again on the off chance that the original rash was caused by something else. On the first day of trying Provigil again the rashes returned in the exact same locations. My doctor is baffled, he is a Sleep Specialist with many patients on Provigil and has never seen this before. I am very frustrated because Provigil works wonders for me and I thought I might have finally found the answer to a problem that has plagued me for over 10 years now. Has anyone else experienced this?

I don't know if you are aware of the serious complications that can arise from the rash you are describing. I have been suffering from a similar terrible rash across my back which is now moving around my shoulders, up the back of my neck, and onto my arms.

I'm writing this to let you know that it's better to deal with the grind and the fog than live with the pain and anguish that are caused by SJS & TENS resulting from the use of Provigil. I know it's rough, but I'm dealing with the same predicament. It's sucks!

Here is some information that might be useful.

The Types of Rashes Provigil (modafinil) Causes
Rashes are not created equal. Some rashes are harmless blotches caused by anything from dry air to cheap soap. The rashes caused by provigil are specifically caused by the use of pharmaceuticals and thus are particularly nasty. They start small and are often initially misdiagnosed. They can expand across the body, become open sores, and invite foreign infections not related to the rash itself. The result can often be fatal for the sufferer.

Erythema multiforme (EM) bulbous - Typically round with well-defined borders. Shows up mostly on the hands, feet, arms, or legs. The rashes are small and irritating, but don’t usually cover the body.

Stevens-Johnson syndrome (SJS) blotchy – These are large oddly shaped blisters that cover the back, chest, or both. The lesions are small to large, irritating, and contain puss. Treatment should be immediate to avoid infections and further spreading.

Toxic epidermal necrolysis (TEN) with spots – These are widespread, irregularly shaped blisters. These blisters are huge and become filled with puss. They can cover the body and leave large open sores that are prone to a variety of infections.

Toxic epidermal necrolysis (TEN) without spots – Like it’s spotty brother, it is widespread, covering the chest and back. These rashes are smaller, but do not commonly blister. They peel off in large strips of skin exposing the area to infection.

Overlap Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS-TEN) all above – This is the most deadly side effect of the drug, which culminates all of the worst elements of the above rashes. Symptoms are described above, but only manifests itself once the rash has become fully realized. Once these rashes are diagnosed, the patient is immediately hospitalized in the burn unit and treated as critical.

I hope you are doing well... and all the best to you!:o)

Here is a small discussion on Brainmeta.com about a user who tried Modafinil and felt like he started experiencing symptoms of SJS.

Also, SJS can be caused by infections like herpes simplex. As an HSV2 carrier myself, I feel this disposes me even more to the susceptibility of developing SJS perhaps exacerbating things by introducing a drug that is prone to causing it.

I could go on and on. My point is, developing a rash or symptoms indicative of a serious medical emergency don't seem to be as rare as the literature suggests. Just have a look on askapatient.com here and search the pages for instances of the word "rash". It comes up quite a lot.

People have taken Modafinil for months before they started showing signs of anything serious. Look at this data from ehealthme.com

Do you still think my fears are unfounded or that I'm being paranoid? For me, it's hard to ignore this information.



This is a post-marketing study of Sjs (Erythema multiforme) among people who take Provigil. The study is created by eHealthMe based on 58 reports from FDA and user community.
What is Provigil

Provigil has active ingredients of modafinil. It is used in narcolepsy, fatigue, drowsiness, sleep disorder, chronic fatigue syndrome, sleep apnea.
On Mar, 24, 2012: 6,757 people reported to have side effects when taking Provigil. Among them, 58 people (0.86%) have Sjs.
Time on Provigil when people have Sjs * :
< 1 month 1 - 6 months 6 - 12 months 1 - 2 years 2 - 5 years 5 - 10 years 10+ years Sjs 90.28% 8.33% 0.00% 0.00% 1.39% 0.00% 0.00%
Gender of people who have Sjs when taking Provigil * :
Female Male Sjs 65.00% 35.00%
Age of people who have Sjs when taking Provigil * :
0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+ Sjs 0.00% 0.00% 12.36% 10.11% 5.62% 28.09% 31.46% 12.36%

Edited by semi-retarded-individual, 06 April 2012 - 09:52 PM.

[unregistered_user]

Sorry, I lost the formatting of some of that info towards the end of the post. To see the data displayed correctly you may visit this page: SJS & Provigil on ehealthme.com

[Raptor87]

ehealthme? Isn´t that were people can simply just diagnose themselves? I have an itch, must be SJS Herpes? Simple rash? The Bruce Allen is an anecdote, this is not evidence! And the symptoms he describes sounds like something else. Sores around one´s mouth is certainly not SJS!

Anyway as I said, SJS also happened in the placebo control group. Sugarpills get it! There is no evidence that Modafinil causes SJS! The only reason why it is mentioned in the warning label is because of one case that later was recanted! The drug was still banned after that! Which of course is a good thing if there were any indications. Today we know better. The warning that you bring from the FDA is the very warning that was put in after the suspected case, this isn´t anything new!

Man if you are not taking the drug then don´t, but let´s be serious about this. This is just general paranoia! 6 cases of millions of users worldwide, I think that the causes were something different looking from a statistical pov. But there is no way to tell it is so, or that this is evidence.

Let´s just cut the bullshit, ok!

[Raptor87]

Brainfogged do you tale it daily? Dose? Thanks

Yes I have been taking it daily now for a couple of weeks. But I have been on and off of it for years. The dosage ranges from 50mg to 450mg. Personally I think the best dose is 100mg, I add another 50mg during the day if needed. Otherwise I do 50mg in the morning, then before lunch I take another 50mg. Another 50mg is added 1h after lunch.

Sideeffects have been itching, dry mouth, swelled muscles, increased anxiety, being overfocused and so on.

I recommend methylcobalamin and ZMA to go with the drug. It keeps some of the symptoms in check for some reasons. Especially anxiety! What is important is getting sufficient sleep, so melatonin is a must! Preferably the 8h time release melatonin. If you don´t sleep, you will die! I can imagine that Modafinil does something to sleep as it scatters my brain if I don't take melatonin every night.

What I have experienced so far while being on it daily, well increased cognition, better long term/short term memory. I can studycram a whole day straight and still remember the stuff without severe impairment of memory. Another positive effect has been less anxiety weirdly enough, I don´t know why. Should be the other way around. Combined with the supplements and daily regime of Modafinil. Well I have experienced an enhancement of caffeine and it gives me some nootropic effects everyday. It was even funny that I outperformed my teacher in programming and he is a genius, I normally have zero attentionspan but I kept remembering stuff that he kept forgetting. I almost started laughing hysterically because he is really smart and I look up to him or rather his brain. Modafinil is a great drug if one can handle it and doesn't suffer from psychological problems. Dont get me wrong, I don't think that it is really a nootropic. But it does elevate the brain to optimal levels when we are tired. So there is no real enhancement. It serves great for those who are impaired on some level though.

[gamesguru]

Does someone have a family history of hypochondriasis? Look, if it causes SJS, it's going to be very mild at first. It's going to affect not 5% of your skin before you realize something freaky is going on.

**Takes 1 microgram modafinil, 1 hour later: http://upload.wikime...on-syndrome.jpg.**

Plus, SJS is one of those things that doesn't tend to be caused by drugs. Drugs can contribute to it in susceptible people, but it's very unlikely that drugs would cause it on their own.

Look at this: http://en.wikipedia....rome#Infections.

It can be caused by many common infections, it says. To answer your question about how you'll know whether you have a flu or SJS, you'll know soon enough! If you're young and healthy and live near a hospital, you're really freaking out. You should be more worried about other things, like catching AIDS from a cough, or viral encephalitis, or dying in a car crash. For goodness' sake, talk some sense into yourself!

[unregistered_user]

Does someone have a family history of hypochondriasis? Look, if it causes SJS, it's going to be very mild at first. It's going to affect not 5% of your skin before you realize something freaky is going on.

**Takes 1 microgram modafinil, 1 hour later: http://upload.wikime...on-syndrome.jpg.**

Plus, SJS is one of those things that doesn't tend to be caused by drugs. Drugs can contribute to it in susceptible people, but it's very unlikely that drugs would cause it on their own.

Look at this: http://en.wikipedia....rome#Infections.

It can be caused by many common infections, it says. To answer your question about how you'll know whether you have a flu or SJS, you'll know soon enough! If you're young and healthy and live near a hospital, you're really freaking out. You should be more worried about other things, like catching AIDS from a cough, or viral encephalitis, or dying in a car crash. For goodness' sake, talk some sense into yourself!

LOL. How droll. Anyway, I mentioned that I have one of the infections that causes it (herpes simplex virus) and my concern with adding Modafinil might only compound the potential for SJS. You think that's being paranoid? I like to think of it as being prudent.

[Raptor87]

Does someone have a family history of hypochondriasis? Look, if it causes SJS, it's going to be very mild at first. It's going to affect not 5% of your skin before you realize something freaky is going on.

**Takes 1 microgram modafinil, 1 hour later: http://upload.wikime...on-syndrome.jpg.**

Plus, SJS is one of those things that doesn't tend to be caused by drugs. Drugs can contribute to it in susceptible people, but it's very unlikely that drugs would cause it on their own.

Look at this: http://en.wikipedia....rome#Infections.

It can be caused by many common infections, it says. To answer your question about how you'll know whether you have a flu or SJS, you'll know soon enough! If you're young and healthy and live near a hospital, you're really freaking out. You should be more worried about other things, like catching AIDS from a cough, or viral encephalitis, or dying in a car crash. For goodness' sake, talk some sense into yourself!

LOL. How droll. Anyway, I mentioned that I have one of the infections that causes it (herpes simplex virus) and my concern with adding Modafinil might only compound the potential for SJS. You think that's being paranoid? I like to think of it as being prudent.

The only thing that I can recognise in what you mention is an adverse herpes reaction. Maybe Modafinil affects t-cells in lymfnodes to tax the flow of osmosis in an aggressive way which makes the cells to vacuolate and later die through apoptosis. An indication for this would be severe swelling in the nodes before any severe reactions happening. But I have never heard of this happening with Modafinil. It is very far fetched.

I think that you are just holding an opinion here. If you don´t have any real science to contribute with then this thread is dead. There is no likelihood that Modafinil causes SJS.

[unregistered_user]

I never claimed to be able to substantiate my fears scientifically. However, let's not forget, this is a forum that consists largely of "anecdotal evidence". It is up to individual users how much stock they wish to place in the experiences of others but in the several years I have been a member here, I have witnessed nearly every poster giving some credibility to the experiences shared by other members.

Not all of us are scientists or researchers. Some of us value the experiences shared by others and weigh them into our decision making. Saying that we should discount the information shared online by others simply because it isn't scientific enough is silly.

Modafinil MAY or MAY NOT induce SJS or other serious side effects. Perhaps the rate of incidences is incredibly low. But, after over a week of doing nothing but reading everything I can pertaining to Modafinil I have decided the risks associated with the possible advantages are far too great for me to assume. I'm not just speaking to the likelihood of SJS; I am also factoring in the other negative things I've read about dependency, psychologically distressing events, etc.

Believe me, I wanted nothing more than this to be the answer I've been looking for. I've spent thousands of dollars between my purchases at sites like iherb, smartpowders, cerebralhealth, amazon, and online pharmacies in the pursuit of something that will address my issues. I don't have money to burn and throwing $100 worth of unopened Modafinil in the trash is the last thing I want to do... BUT, I can't ignore my findings. I am making a personal judgement regarding my own health and safety which is what everyone here should be doing. I have no agenda and do not wish to discourage anyone else from experimenting with Modafinil, I have simply concluded experimenting with it goes beyond the personal risk limit I have set for myself.

If it works for you - great. Don't hold it against me for deciding I'm not comfortable assuming whatever degree of risk may or may not be involved with its use.

Edited by semi-retarded-individual, 08 April 2012 - 05:06 AM.

[unregistered_user]

ehealthme? Isn´t that were people can simply just diagnose themselves? I have an itch, must be SJS Herpes? Simple rash? The Bruce Allen is an anecdote, this is not evidence! And the symptoms he describes sounds like something else. Sores around one´s mouth is certainly not SJS!

Funny... you cited ehealthme in your thread about Modafinil emptying your head.

So... was Modafinil the culprit here?

[Raptor87]

ehealthme? Isn´t that were people can simply just diagnose themselves? I have an itch, must be SJS Herpes? Simple rash? The Bruce Allen is an anecdote, this is not evidence! And the symptoms he describes sounds like something else. Sores around one´s mouth is certainly not SJS!

Funny... you cited ehealthme in your thread about Modafinil emptying your head.

So... was Modafinil the culprit here?

I actually tried to find a reason for my problems and Modafinil was a reason for it. It seems that this effect does happen to a few people. And those were the only sources I found, keep in mind that I was asking and needed to make the research to guideline myself in to an answer. Later on I contacted a professor in neurology who confirmed that his actually happens with a few people. He didn´t have any answers on why.

You can also recognise that if one diagnoses a very rare dangerous case as SJS on ehealthme, then that will probably be utter bs. Having SJS is very very serious and ehealthme doesn´t cut it. I somehow doubt that these people suffered from giant puss filled blister that exploded and had severe skin necrosis while their organs were shutting down while being in the ER. A simple rash was probably their reasons for their self- diagnosis. Otherwise it would be on the news!

I find it amusing that you are trying to find reasons to diminish what I have said through digging thourgh my past threads. This doesn´t have anything to do with our earlier conversation and how I guideline myself doesn´t have anything to do with the fact´s that I have said in this thread. Keep who we are to yourself, even if you take things personally. Never did I diagnose myself, or alarm people nor did I presume that I would get an adverse reaction from the drug besides the reaction I did have.

Now for Modafinil. The blank state that I mentioned, I think that this happens because of the ratio one has of serotonin and also the sleep-quality one get´s. Modafinil affects wakefulness in the Amygdala. Both Amygdala and different levels of serotonin can cause cognitive problems like this, there is evidence that suggests that Modafinil affects choline, histamine and serotonin and also Gaba on some level.

This answer to the problem is of course a theory from my side. If one is having these problems then supplementing with choline could help. For me, Melatonin helped. Melatonin affects both sleep and serotonin levels. A reason why I have this theory. If it is supported I don't know, but it could help someone who is taking it and having the same problems. Modafinil can help a lot of people if it is used right for the right causes, (note that I don´t promote the use of any drugs).

You have alarmed people enough. Kindly respect other people as medicating can already be hard enough for some. Screaming fire every time someone strikes up a match doesn´t mean that there is an actual fire.

[noos]

What I have experienced so far while being on it daily, well increased cognition, better long term/short term memory. I can studycram a whole day straight and still remember the stuff without severe impairment of memory. Another positive effect has been less anxiety weirdly enough, I don´t know why. Should be the other way around.

I think a good level of arousal is good to reduce anxiety, especially social. Maybe it has to do with norepinephrine or PFC activation that helps control the amigdala, I am not sure.

Edited by noos, 08 April 2012 - 08:03 PM.

[MattJ]

In my opinion, there's no point to researching these types of drugs if you're not willing to take a very small amount of risk into account. The risks here are minimal compared to most other drugs out there, and I will be trying my modifinil out tomorrow.

[Raptor87]

In my opinion, there's no point to researching these types of drugs if you're not willing to take a very small amount of risk into account. The risks here are minimal compared to most other drugs out there, and I will be trying my modifinil out tomorrow.

Exactly, just because some people have severe allergic reactions from nuts does it mean that I will have one, I can avoid them and live under the presumption that I am allergic. But that would be stupid if there is no such evidence that it will happen.

As for Modafinil and SJS, I don´t think that Modafinil can cause those reactions in normal healthy individuals.

[UnbelievablePerson]

I just started another thread on a similar topic.

I have some attached literature you all might find interesting.

Mine question is based in Pharmacogenetics and I would appreciate informed input.

http://www.longecity...-and-modafinil/

[UnbelievablePerson]

ooops double post sorry

Edited by PittedPanda, 11 April 2012 - 12:19 AM.

[Junk Master]

IMO the SJS thing is way overblown, but the addiction potential is very understated. Plus, it's highly disruptive of sleep architecture and if taken in 400 mg doses for an extended period of time will do a number on your health-- sleep IS important.

That said, once a week for a long study session or a big workout-- 400 mg works wonderfully.

[wni420]

Ive done cycles of Modafinils over years...

 

...And it seems I do start to get some rashes in random places

 

So just now, on my Modafinil cycle, I started getting those rashes

 

In the past they seem to have subsided when I took some time off.

 

This time Ill record, SPECIFICALLY how long it takes for the rashes to disappear 

 

 

However, Its a bit surprising to me given the other strong skin aid supplements Im taking, yet Modafinil is still doing its skin damage (Modafinil, I take 200-400mg, 2-3x per week):

High Dose NAC 2-3g per day

High DHA Fish Oil 1.5-2.5g per day

Accutane 80mg per day

 

 

And Ive been very strict with a nutritional protocol that I know is OPTIMAL FOR ME, cant speak for anyone else (gluten-free, dairy free, low-carbs)

[Mind_Paralysis]

Ive done cycles of Modafinils over years...

 

...And it seems I do start to get some rashes in random places

 

So just now, on my Modafinil cycle, I started getting those rashes

 

In the past they seem to have subsided when I took some time off.

 

This time Ill record, SPECIFICALLY how long it takes for the rashes to disappear 

 

 

However, Its a bit surprising to me given the other strong skin aid supplements Im taking, yet Modafinil is still doing its skin damage (Modafinil, I take 200-400mg, 2-3x per week):

High Dose NAC 2-3g per day

High DHA Fish Oil 1.5-2.5g per day

Accutane 80mg per day

 

 

And Ive been very strict with a nutritional protocol that I know is OPTIMAL FOR ME, cant speak for anyone else (gluten-free, dairy free, low-carbs)

 

Those won't help, because Modafinil increases histamine-release - doesn't matter if you remove any obvious allergens - in susceptible people, your histamine-levels will reach such a high level that many things you'd never react to otherwise, will start causing reactions - like the additives in the Modafinil-pills.

 

Anyways, I recommend you try out LEVOcetirizine - not regular Cetirizine (zyrtec, etc) - LEVO. The Levo-enantiomer is the most selective of the two, and won't cross the blood-brain barrier, while the racemic mix will - for some, it cancels the effects of Modafinil to a great extent - for others, regular Cetirizine has no effect on Modafinil's effects. Depends on how much your cognitions responds to histamine, and not DA or NE, I guess.

 

Levocetirizine is the first-line medication when it comes to Urtikaria, which is basically what you're describing - it ought to have some effect.

 

 

Here's a proof of concept:

https://www.reddit.c...mines_bad_idea/