This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Provigil (Modafinil) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (249)
Death (8)
Life Threatening Events (2)
Disability (7)
Reports by Reaction Type
Depression (23),
Suicidal Ideation (22),
Drug Ineffective (19),
Maternal Exposure During Pregnancy (18),
Headache (17),
Mania (16),
Hallucination (16),
Anxiety (14),
Drug Interaction (13),
Nausea (13),
Paranoia (12),
Insomnia (12)
Below are a few examples of reports where side effects / adverse reactions may be related to Provigil (Modafinil). For a complete list or a specific selection of reports, please use the links above.
Possible Provigil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male, weighing 4.5 kg (9.8 pounds)
Reactions: Macrosomia
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: Omeprazole; Multi-Vitamins; Calamine; Insulin Aspart; Ammonium Lactate; Lactobacillus Acidophilus; Ascorbic Acid; Lantus; Ondansetron; Sertraline Hydrochloride
Possible Provigil side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: female, weighing 87.6 kg (192.8 pounds)
Reactions: Supraventricular Tachycardia, Live Birth, Polyhydramnios
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: Omeprazole; Insulin Aspart; Calamine; Lantus; Lactobacillus Acidophilus; Ascorbic Acid; Sertraline Hydrochloride; Multi-Vitamins; Ammonium Lactate; Ondansetron
Possible Provigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female, weighing 79.5 kg (174.8 pounds)
Reactions: Off Label Use, Drug Ineffective
Drug(s) suspected as cause:
Nuvigil
Indication: Fatigue
Provigil
Indication: Fatigue
Other drugs received by patient: Lamictal
Possible Provigil side effects in female
Reported by a physician from United States on 2012-08-21
Patient: female, weighing 64.0 kg (140.8 pounds)
Reactions: Supraventricular Extrasystoles, Live Birth, Retained Placenta or Membranes
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: Multi-Vitamins
Possible Provigil side effects in female
Reported by a physician from United States on 2012-08-17
Patient: female
Reactions: Talipes
Drug(s) suspected as cause:
Provigil
Possible Provigil side effects in female
Reported by a physician from United States on 2012-08-17
Patient: female, weighing 60.4 kg (132.8 pounds)
Reactions: Foetal Distress Syndrome, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Provigil
Administration route: Oral
Indication: Narcolepsy
Start date: 2002-01-01
End date: 2011-01-01
Provigil
Dosage: 28.5714 milligram daily;
Administration route: Oral
Start date: 2002-01-01
End date: 2011-01-01
Ritalin
Dosage: 10 milligram daily;
Indication: Narcolepsy
Start date: 2011-01-02
Other drugs received by patient: Zyrtec; Multi-Vitamins
Possible Provigil side effects in male
Reported by a physician from United States on 2012-08-16
Patient: male
Reactions: Positional Plagiocephaly, Craniofacial Dysostosis, Congenital Torticollis, Gastrooesophageal Reflux Disease, Brachycephaly
Drug(s) suspected as cause:
Provigil
Possible Provigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: female, weighing 73.0 kg (160.6 pounds)
Reactions: Off Label Use, Suicidal Ideation
Drug(s) suspected as cause:
Provigil
Indication: Fatigue
Start date: 2012-01-01
Rebif
Dosage: 18.8571 microgram daily;
Indication: Multiple Sclerosis
Start date: 2009-07-19
Other drugs received by patient: Unspecified Medication; Amantadine HCL
Possible Provigil side effects in
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient:
Reactions: Cleft Palate, Developmental Delay, Hypotonia
Drug(s) suspected as cause:
Provigil
Possible Provigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: female
Reactions: Metabolic Acidosis, Overdose, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: Symbicort; Metoprolol Tartrate; Enablex
Possible Provigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: female
Reactions: Overdose, Metabolic Acidosis, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: Enablex; Metoprolol Tartrate; Symbicort
Possible Provigil side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Ambien CR
Amoxicillin
Dosage: 0.5, qd
Arthrotec
Administration route: Oral
Biaxin
Cefzil
Lipitor
Administration route: Oral
Livalo
Lortab
Oxacillin Sodium
PCE
Pravachol
Provigil
Sulfamethoxazole
Ultram
Zetia
Administration route: Oral
Zocor
Administration route: Oral
Possible Provigil side effects in 63 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26
Patient: 63 year old female, weighing 48.1 kg (105.8 pounds)
Reactions: Weight Decreased, Impaired Driving Ability, Visual Impairment
Drug(s) suspected as cause:
Geodon
Provigil
Indication: Depression
Start date: 2007-04-01
End date: 2010-12-22
Seroquel
Administration route: Oral
Start date: 2008-09-01
End date: 2010-09-01
Other drugs received by patient: Lamictal; Alprazolam; Ambien; Deplin
Possible Provigil side effects in
Reported by a individual with unspecified qualification from United States on 2012-07-18
Patient:
Reactions: Product Substitution Issue, Adverse Event
Drug(s) suspected as cause:
Modafinil
Provigil
Possible Provigil side effects in 46 year old male
Reported by a individual with unspecified qualification from United States on 2012-07-18
Patient: 46 year old male
Reactions: Gingival Pain, Gingival Swelling, Gingival Disorder
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: Depakote; Clonopin; Ativan
Possible Provigil side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: male
Reactions: Renal Cell Carcinoma, Central Nervous System Lesion
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: BP Meds; Chemo Drugs
Possible Provigil side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-07-09
Patient: 50 year old female
Reactions: Cardiac Disorder
Drug(s) suspected as cause:
Provigil
Dosage: 400 milligram;
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2011-01-01
End date: 2011-01-01
Provigil
Indication: Circadian Rhythm Sleep Disorder
Other drugs received by patient: Requip; Calcium; Glucosamine; Fish OIL; Vyvanse; Vitamin D
Possible Provigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female
Reactions: Anxiety, Drug Ineffective, Feeling Jittery, Headache, Somnolence, Decreased Appetite
Drug(s) suspected as cause:
Nuvigil
Dosage: every am
Administration route: Oral
Indication: Insomnia
Provigil
Other drugs received by patient: Celexa; Sprintec
Possible Provigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: female, weighing 104.4 kg (229.7 pounds)
Reactions: Thrombosis, Off Label Use, Incorrect Dose Administered
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Provigil
Dosage: 400 milligram;
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2012-04-28
End date: 2012-06-01
Provigil
Dosage: 200 milligram;
Administration route: Oral
Indication: Fatigue
End date: 2012-04-27
Other drugs received by patient: Natalizumab
Possible Provigil side effects in male
Reported by a individual with unspecified qualification from United States on 2012-06-28
Patient: male
Reactions: Completed Suicide
Adverse event resulted in: death
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: Ambien; Pepcid; Tramadol HCL; Neproxin; Blood Pressure Medication
Possible Provigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-28
Patient: female
Reactions: Migraine, Drug Ineffective, Pain, Myofascial Pain Syndrome, Osteoarthritis, Neuropathy Peripheral, Fatigue, Temporomandibular Joint Syndrome, Intervertebral Disc Degeneration, Carpal Tunnel Syndrome, Spinal Disorder
Drug(s) suspected as cause:
Ambien
Dosage: unk
Indication: Pain
Celebrex
Dosage: unk
Indication: Pain
Codeine Sulfate
Dosage: unk
Indication: Pain
Cymbalta
Dosage: unk
Indication: Pain
Darvocet-N 50
Dosage: unk
Indication: Pain
Lyrica
Dosage: unk
Indication: Pain
Provigil
Dosage: unk
Indication: Pain
Ultram
Dosage: unk
Indication: Pain
Possible Provigil side effects in female
Reported by a physician from United States on 2012-06-26
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Ambien CR
Dosage: unk
Amoxicillin
Dosage: 0.5 unk, 1x/day
Arthrotec
Dosage: unk
Administration route: Oral
Biaxin
Dosage: unk
Cefzil
Dosage: unk
Lipitor
Dosage: unk
Administration route: Oral
Livalo
Dosage: unk
Lortab
Dosage: unk
Oxacillin Sodium
Dosage: unk
PCE
Dosage: unk
Pravachol
Dosage: unk
Provigil
Dosage: unk
Sulfamethoxazole
Dosage: unk
Ultram
Dosage: unk
Zetia
Dosage: unk
Zocor
Dosage: unk
Possible Provigil side effects in female
Reported by a individual with unspecified qualification from United States on 2012-06-26
Patient: female
Reactions: Burning Sensation, Feeling Jittery, Rash Maculo-Papular, Scar
Drug(s) suspected as cause:
Nuvigil
Dosage: 250mg once a day po
Administration route: Oral
Indication: Insomnia
Provigil
Dosage: 400mg once a day po
Administration route: Oral
Indication: Insomnia
Other drugs received by patient: Thymodil; Topral; Celexa; Aspirin; Cinthroid
Possible Provigil side effects in 58 year old female
Reported by a physician from United States on 2012-06-20
Patient: 58 year old female
Reactions: Electrocardiogram QT Prolonged, Heart Rate Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Obetrol
Provigil
Administration route: Oral
Other drugs received by patient: Ziprasidone HCL
Possible Provigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: female, weighing 68.1 kg (149.8 pounds)
Reactions: Off Label Use, Lower Limb Fracture
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: Hydrocodone; Hydrocodone; Tramadol HCL; Allergy Medication; Alprazolam; Clonazepam
Possible Provigil side effects in
Reported by a physician from United States on 2012-05-31
Patient:
Reactions: Palpitations, Chest Pain, Insomnia, Cardiac Arrest, Myocardial Infarction
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Armodafinil
Dosage: 150 milligram;
Administration route: Oral
Provigil
Dosage: 100 milligram;
Administration route: Oral
Possible Provigil side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-31
Patient: male, weighing 143.0 kg (314.6 pounds)
Reactions: Fatigue, Drug Effect Increased, Pulmonary Embolism, Feeling Abnormal, Somnolence, Discomfort
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: Metoprolol Tartrate; Furosemide; Cyclobenzaprine; Omeprazole; Levothyroxine Sodium; Ropinirole; Tramadol HCL; Warfarin Sodium; Percocet
Possible Provigil side effects in 47 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-25
Patient: 47 year old male, weighing 90.3 kg (198.6 pounds)
Reactions: Hangover
Drug(s) suspected as cause:
Provigil
Dosage: 200mg daily po
Administration route: Oral
Indication: Multiple Sclerosis
Start date: 2011-01-01
End date: 2012-03-01
Provigil
Dosage: 200mg daily po
Administration route: Oral
Indication: Fatigue
Start date: 2011-01-01
End date: 2012-03-01
Possible Provigil side effects in 74 year old male
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: 74 year old male, weighing 77.1 kg (169.6 pounds)
Reactions: Product Substitution Issue, Drug Ineffective, Feeling Abnormal
Drug(s) suspected as cause:
Provigil
Possible Provigil side effects in male
Reported by a physician from United States on 2012-05-21
Patient: male, weighing 4.0 kg (8.9 pounds)
Reactions: Cryptorchism, Hypospadias, Inguinal Hernia
Drug(s) suspected as cause:
Provigil
Other drugs received by patient: Synthroid; Metformin HCL; Valtrex
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