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Provigil (Modafinil) - Side Effect Reports to FDA

 
 



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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