The modafinil label: serious rash including SJS, weaker birth control, and not approved for children
Provigil is approved for sleepiness in narcolepsy, sleep apnea and shift work disorder. Its label warns of serious rash including Stevens-Johnson syndrome, says it can make hormonal contraception fail, and is not approved for children.
Reasonable evidence with real limitations. how we score evidence
Caveat on this rating: Serious rash rates come from pediatric trials; adult postmarketing reports have no denominator. ADHD benefit in children was offset by rash cases and is not an approved use.
The FDA-approved label for modafinil (Provigil), read for the three warnings people taking it off-label most often miss.
Significant findings
PROVIGIL "is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD)." In sleep apnea it treats the sleepiness, "not... the underlying obstruction". It is a Schedule IV controlled substance and carries no boxed warning.
Warning 5.1, Serious Rash, including Stevens-Johnson Syndrome: in trials, rash leading to discontinuation occurred in "approximately 0.8% (13 per 1,585)" of pediatric patients, including one possible case of SJS and one apparent multi-organ hypersensitivity reaction, against none of 380 on placebo. Rare serious or life-threatening rashes, including SJS, TEN and DRESS, have been reported in adults and children after marketing, and "PROVIGIL should be discontinued at the first sign of rash, unless the rash is clearly not drug-related."
Section 7, contraception: "The effectiveness of steroidal contraceptives may be reduced when used with PROVIGIL and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended".
Section 8.4, children: "PROVIGIL is not approved in this population for any indication." In a 6 week study of 165 children with narcolepsy there was no significant benefit over placebo. Warning 5.5 advises caution with a history of psychosis, depression or mania.
The other direction
The same section 8.4 reports that three pediatric ADHD trials "showed statistically significant differences favoring modafinil over placebo", and then that "there were 3 cases of serious rash including one case of possible SJS among 933 patients exposed", which is why "Modafinil is not approved for use in treating ADHD." The serious rash rates are pediatric trial figures; the adult postmarketing reports have no denominator.
What this does not show
It does not show modafinil works for depression, fatigue or focus in healthy people; those are not approved uses. It is not a reason to stop a prescribed drug.
Worth asking
If I use hormonal birth control, what backup method should I use while on this and for a month after?
Source
PROVIGIL (modafinil) tablets: FDA-approved prescribing information, Warnings and Precautions 5.1 and 5.5, Drug Interactions 7, Pediatric Use 8.4 — Cephalon, LLC; US Food and Drug Administration (2025)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- Industry funded
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published October 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "moderate evidence". Reasonable evidence with real limitations. It scores 57 out of 100 on our published rubric. One caveat travels with that badge: Serious rash rates come from pediatric trials; adult postmarketing reports have no denominator. ADHD benefit in children was offset by rash cases and is not an approved use. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
PROVIGIL (modafinil) tablets: FDA-approved prescribing information, Warnings and Precautions 5.1 and 5.5, Drug Interactions 7, Pediatric Use 8.4 — Cephalon, LLC; US Food and Drug Administration (2025). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: Industry funded. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is modafinil (Provigil), provigil FDA approved?
Yes — this medication carries FDA approval. Approval is always for a specific indication, not for every use it is prescribed for.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.