Modvigil Side Effects & Precautions
Modvigil is very well tolerated by the vast majority of individuals. In fact, a recent study found that Modafinil had zero recorded deaths in its 18 years of use in 20 countries . Having said that, no drug is completely void of possible adverse reactions.
Please read the following official warnings and precautions for Provigil branded Modafinil.
Provigil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil.
WARNINGS AND PRECAUTIONS
Serious Rash, including Stevens-Johnson Syndrome: Discontinue PROVIGIL at the first sign of rash, unless the rash is clearly not drug-related.
Angioedema and Anaphylaxis Reactions: If suspected, discontinue PROVIGIL.
Multi-organ Hypersensitivity Reactions: If suspected, discontinue PROVIGIL.
Persistent Sleepiness: Assess patients frequently for degree of sleepiness and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity.
Psychiatric Symptoms: Use caution in patients with a history of psychosis, depression, or mania. Consider discontinuing PROVIGIL if psychiatric symptoms develop.
Known Cardiovascular Disease: Consider increased monitoring.
Most common adverse reactions (≥5%): headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.
Steroidal contraceptives (e.g., ethinyl estradiol): Use alternative or concomitant methods of contraception while taking PROVIGIL and for one month after discontinuation of PROVIGIL treatment.
Cyclosporine: Blood concentrations of cyclosporine may be reduced.
CYP2C19 substrates, such as omeprazole, phenytoin, and diazepam: Exposure of these medications may be increased.
Pregnancy: Based on animal data, may cause fetal harm.