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This is an index of reports of adverse events (side effects, adverse reactions, etc.) related to Provigil (Modafinil). Click on the relevant link below to view a selection of reports according to the event's seriousness level and/or the nature of the side effect / adverse reaction. Or scroll down to view a sample of recent reports further on this page.
Our database includes reports from Jan 2007 to Dec 2007. The information is not vetted and should not be cosidered as verified clinical evidence.
All cases (115)
Cases resulting in a serious event (112)
Cases resulting in death (7)
Cases resulting in life threatening events (6)
Cases resulting in hospitalization (47)
Cases resulting in disability (7)
Cases resulting in other serious reactions (66)
Below is a sample of reports where side effects / adverse reactions may be related to Provigil (Modafinil). For a complete list and/or a specific selection of reports, please use the links in the index above.
Adverse event in 29 year old female receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-31
Patient: 29 year old female
Adverse reactions / side effects: Angioedema, Oral Herpes
Suspect drug(s):
Provigil (Modafinil)
Adverse event in male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-31
Patient: male, weighing 52.6 kg (115.8 pounds)
Adverse reactions / side effects: Palpitations, Dizziness, Vision Blurred, Urinary Retention
Adverse event resulted in: disablity
Suspect drug(s):
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Depression
Start date: 2007-05-04
End date: 2007-05-08
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Somnolence
Start date: 2007-05-04
End date: 2007-05-08
Other drugs received by patient: Bupropion HCL; Lamictal; Restoril / 00393701 /; Percocet
Adverse event in male receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-10-31
Patient: male, weighing 87.1 kg (191.6 pounds)
Adverse reactions / side effects: Asthma, Dyspnoea, Drug Ineffective, Tachycardia, Chest Pain, Oedema, Vasodilatation, Hypertension
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Provigil
Dosage: 400 mg tid oral
Administration route: Oral
Indication: Narcolepsy
End date: 2007-07-01
Provigil
Dosage: 200 mg tid oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2007-07-01
End date: 2007-07-01
Provigil
Dosage: 400 mg tid oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2007-07-01
Other drugs received by patient: Adderall 10
Adverse event in female receiving Provigil (Modafinil)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-31
Patient: female, weighing 63.0 kg (138.7 pounds)
Adverse reactions / side effects: Blood Alkaline Phosphatase Increased, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: Cymbalta; Adderall XR 10; Estradiol; Folic Acid; Abilify
Adverse event in 44 year old female receiving Provigil (Modafinil)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-31
Patient: 44 year old female
Adverse reactions / side effects: Anxiety, Hypersensitivity
Suspect drug(s):
Epinephrine
Dosage: 2 pens administered in one week prn
Indication: Hypersensitivity
Provigil
Dosage: oral
Administration route: Oral
End date: 2007-10-17
Adverse event in male receiving Provigil (Modafinil)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-31
Patient: male, weighing 76.4 kg (168.1 pounds)
Adverse reactions / side effects: Asthma, Dyspnoea
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: ONE-A-DAY Men's
Adverse event in male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-31
Patient: male, weighing 72.6 kg (159.7 pounds)
Adverse reactions / side effects: Blood Urea Increased, Visual Acuity Reduced, Blood Creatinine Increased, Hypertension
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: Lisinopril; Protonix / 01263201 /; Aspirin; Multivitamin / 00831701 /
Adverse event in female receiving Provigil (Modafinil)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-31
Patient: female, weighing 77.1 kg (169.6 pounds)
Adverse reactions / side effects: Ventricular Extrasystoles, Extrasystoles
Suspect drug(s):
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Depression
Start date: 2005-09-01
End date: 2006-07-01
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Fatigue
Start date: 2005-09-01
End date: 2006-07-01
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Hypersensitivity
Start date: 2005-09-01
End date: 2006-07-01
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Depression
Start date: 2006-07-01
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Fatigue
Start date: 2006-07-01
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Hypersensitivity
Start date: 2006-07-01
Other drugs received by patient: Cymbalta
Adverse event in male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-31
Patient: male, weighing 93.2 kg (205.0 pounds)
Adverse reactions / side effects: Blood Pressure Increased, Epistaxis
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: Testosterone
Adverse event in 36 year old female receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-31
Patient: 36 year old female
Adverse reactions / side effects: Abortion Spontaneous
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: Lexapro
Adverse event in female receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-31
Patient: female, weighing 93.4 kg (205.6 pounds)
Adverse reactions / side effects: Chest Discomfort, Dyspnoea, Wheezing, Cough
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: Metaglip; Imuran / 00001501 /; Prednisone; Restoril / 00393701 /; Prevacid; Diovan / 01319601 /
Adverse event in 32 year old male receiving Provigil (Modafinil)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-31
Patient: 32 year old male
Adverse reactions / side effects: Palpitations
Suspect drug(s):
Provigil (Modafinil)
Adverse event in 47 year old female receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-31
Patient: 47 year old female
Adverse reactions / side effects: Blood Cortisol Increased
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: Effexor; Trazodone HCL; Lunesta; Diclofenac; Estrogen Troche; Zyrtec; Buspar; Rinocort; Vitamin + Mineral Complex; Glucosamine; Omega 3
Adverse event in 56 year old female receiving Provigil (Modafinil)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-29
Patient: 56 year old female, weighing 81.6 kg (179.6 pounds)
Adverse reactions / side effects: Oral Mucosal Blistering, Dysphagia, Dystonia, Impaired Work Ability, Swollen Tongue, Throat Tightness, Speech Disorder, Impaired Driving Ability, Oral Pain, Oedema Mouth, Gastrooesophageal Reflux Disease
Adverse event resulted in: disablity
Suspect drug(s):
Provigil
Dosage: 50 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-01-01
End date: 2006-09-01
Provigil
Dosage: 100 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-09-01
End date: 2007-09-29
Other drugs received by patient: Lyrica; Nefazodone HCL; Crestor; Evista; Metoclopramide; Lisinopril; Nexium
Adverse event in 37 year old female receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-10-29
Patient: 37 year old female, weighing 79.8 kg (175.6 pounds)
Adverse reactions / side effects: Neutrophil Count Increased, Neutrophil Count Decreased
Adverse event resulted in: hospitalization
Suspect drug(s):
Provigil (Modafinil)
Other drugs received by patient: Zoloft; Prednisone; Procardia; Altace; Oscal; Aspirin
Adverse event in female receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-29
Patient: female, weighing 50.0 kg (110.0 pounds)
Adverse reactions / side effects: Urticaria
Suspect drug(s):
Provigil (Modafinil)
Adverse event in 56 year old female receiving Provigil (Modafinil)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-29
Patient: 56 year old female, weighing 81.6 kg (179.6 pounds)
Adverse reactions / side effects: Oral Mucosal Blistering, Dysphagia, Dystonia, Impaired Work Ability, Swollen Tongue, Throat Tightness, Speech Disorder, Oral Pain, Uterine Dilation and Curettage, Oedema Mouth, Gastrooesophageal Reflux Disease
Adverse event resulted in: disablity
Suspect drug(s):
Provigil
Dosage: 50 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-01-01
End date: 2006-09-01
Provigil
Dosage: 100 mg qd oral
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2006-09-01
End date: 2007-09-29
Other drugs received by patient: Lyrica; Nefazodone HCL; Crestor; Evista; Metoclopramide; Lisinopril; Nexium
Adverse event in 59 year old male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-26
Patient: 59 year old male, weighing 90.7 kg (199.6 pounds)
Adverse reactions / side effects: Back Pain, Chest Discomfort, Fatigue, Drug Ineffective, Blood Cholesterol Increased, Condition Aggravated, Hypertension, Cardiac Disorder
Suspect drug(s):
Provigil
Dosage: 400 mg qd oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2004-01-01
End date: 2004-01-01
Provigil
Dosage: 400 mg bid oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2004-01-01
Other drugs received by patient: Ritalin; Amphetamine and Dextroamphetamine Salts; Desoxyn
Adverse event in 72 year old female receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-26
Patient: 72 year old female, weighing 104.3 kg (229.5 pounds)
Adverse reactions / side effects: Narcolepsy, Photosensitivity Reaction, Stomatitis, Swelling Face, Drug Ineffective, Condition Aggravated, Erythema, Rash Pruritic, Dermatitis Contact, Oral Discomfort, Oral Pain, Oedema Mouth
Suspect drug(s):
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2000-01-01
End date: 2007-09-01
Provigil
Dosage: 200 mg bid oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2007-09-14
Other drugs received by patient: Lisinopril; Glucophage; Ditrophan XL; Lamisil / 00992601 /; Allopurinol
Adverse event in 72 year old female receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-26
Patient: 72 year old female, weighing 104.3 kg (229.5 pounds)
Adverse reactions / side effects: Oral Discomfort, Dermatitis Contact, Photosensitivity Reaction, Stomatitis, Swelling Face, Drug Ineffective, Rash Erythematous, Oedema Mouth, Rash Pruritic
Suspect drug(s):
Provigil
Dosage: 200 mg qd oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2000-01-01
End date: 2007-09-01
Provigil
Dosage: 200 mg bid oral
Administration route: Oral
Indication: Narcolepsy
Start date: 2007-09-14
Other drugs received by patient: Lisinopril; Glucophage; Ditropan XL; Lamisil; Allopurinol
Adverse event in 48 year old female receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-10-23
Patient: 48 year old female, weighing 190.5 kg (419.1 pounds)
Adverse reactions / side effects: Pruritus, Drug Ineffective, Dyskinesia, Oral Discomfort, Hypoaesthesia Oral, Dyspepsia, LIP Exfoliation, Candidiasis, Migraine, Respiratory Rate Increased, Stomatitis, Dysphagia, LIP DRY, Nausea, Paraesthesia Oral, Malnutrition, Anaemia, Muscle Twitching, Tremor, Visual Disturbance, Choking, Impaired Gastric Emptying, Tardive Dyskinesia
Adverse event resulted in: hospitalization
Suspect drug(s):
Provigil
Dosage: qd oral
Administration route: Oral
Indication: Fatigue
Start date: 2006-09-01
End date: 2006-09-15
Risperdal
Dosage: 3 mg qd oral
Administration route: Oral
Indication: Depression
Start date: 2002-01-01
End date: 2006-09-15
Other drugs received by patient: Effexor XR; Lithium Carbonate; Prilosec; Enablex; Lipitor; Triamterene; Mirapex; Potassium Chloride; Coumadin
Adverse event in 55 year old female receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-23
Patient: 55 year old female, weighing 81.6 kg (179.6 pounds)
Adverse reactions / side effects: Drug Interaction, Convulsion
Suspect drug(s):
Lexapro
Dosage: 10 mg qd oral
Administration route: Oral
Indication: Depression
Provigil
Dosage: 100 mg bid oral
Administration route: Oral
Indication: Hypersomnia
Start date: 2007-09-07
End date: 2007-09-08
Provigil
Dosage: 100 mg qd oral
Administration route: Oral
Indication: Hypersomnia
Start date: 2007-09-09
Other drugs received by patient: Lorazepam; Zyrtec; Hormone Replacement Therapy (Unspecified)
Adverse event in 67 year old male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-23
Patient: 67 year old male
Adverse reactions / side effects: Anaphylactic Shock
Suspect drug(s):
Provigil (Modafinil)
Adverse event in 48 year old female receiving Provigil (Modafinil)
Reported by a consumer/non-health professional from United States on 2007-10-23
Patient: 48 year old female, weighing 190.5 kg (419.1 pounds)
Adverse reactions / side effects: Choking Sensation, Pruritus, Dyskinesia, Pain, Photopsia, Oral Discomfort, Hypoaesthesia Oral, Laboratory Test Abnormal, Oral Candidiasis, Eye Disorder, LIP Exfoliation, Respiratory Rate Increased, Migraine, Dysphagia, Vomiting, Stomatitis, Nausea, Paraesthesia Oral, LIP DRY, Anaemia, Ill-Defined Disorder, Muscle Twitching, Eye Pain, Tremor, Mucosal Inflammation, Oral Pain, Visual Disturbance, Oral Disorder, Impaired Gastric Emptying, Tardive Dyskinesia, Inflammation
Adverse event resulted in: hospitalization
Suspect drug(s):
Provigil
Dosage: qd oral
Administration route: Oral
Indication: Fatigue
Start date: 2006-09-01
End date: 2006-09-15
Risperdal
Dosage: 3 mg qd oral
Administration route: Oral
Indication: Depression
Start date: 2002-01-01
End date: 2006-09-15
Other drugs received by patient: Effexor XR; Lithium; Prilosec / 00661201 /; Enablex; Lipitor; Triamterene; Mirapex; Potassium Chloride; Coumadin
Adverse event in 67 year old male receiving Provigil (Modafinil)
Reported by a physician from United States on 2007-10-23
Patient: 67 year old male
Adverse reactions / side effects: Anaphylactic Shock
Suspect drug(s):
Provigil (Modafinil)
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