Modafinil and Your Skin: The Risk of Stevens-Johnson Syndrome (SJS)

Stevens-Johnson Syndrome (SJS) Threat Overblown

Stevens-Johnson Syndrome affecting the eye
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A common fear is concerning modafinil usage being linked to Stevens-Johnson Syndrome (SJS), a rare, serious disorder of the skin and mucous membranes. A number of people have been scared off by the threat of serious skin reaction from taking this drug which for many has been life-changing and even life-saving. There is no evidence that SJS is more likely among modafinil users. The FDA rejected the usage of modafinil to treat Attention Deficit/Hyperactivity Disorder (ADHD) in children based on a single adverse reaction of SJS in a 10-year old. This diagnosis was later recanted by the physician that diagnosed the child. There are a few anecdotal reports online of people being diagnosed with SJS, a friend being diagnosed, or acquaintances of physicians that have diagnosed modafinil users with SJS but there is little evidence provided.

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The FDA received only six claims of adverse skin reactions, which included SJS and other serious diseases, over a period from 1998 to 2007:

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…

In conclusion, don’t let the fear of adverse skin reaction keep you from trying modafinil if you think it could have positive benefits to your life. SJS is an extremely rare disorder and has not been proven that modafinil usage is likely to trigger a higher rate of Stevens-Johnson reactions. In addition, a number of widely used drugs have had reported SJS reactions, including ibuprofen, naproxen (Aleve), acetaminophen (Tylenol), and bactrim. Acetaminophen alone was responsible for 107 cases of adverse reaction from 1969 to 2012, including 67 hospitalizations, and now carries a warning about possible serious skin reactions. The threat of serious reaction is several times more likely from these common Over The Counter (OTC) pain relievers than from modafinil.


FDA Drug Safety Newsletter, Fall 2007 –

Stevens-Johnson Syndrome –

FDA Warns of Rare Acetaminophen Risk –

Stevens Johnson Syndrome –

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