This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nuvigil (Armodafinil) 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 (981)
Death (13)
Life Threatening Events (3)
Disability (4)
Reports by Reaction Type
Drug Ineffective (164),
Headache (105),
Insomnia (93),
Nausea (67),
Rash (54),
Off Label Use (53),
Feeling Abnormal (47),
Anxiety (45),
Somnolence (41),
Dizziness (40),
Drug Tolerance (32),
Palpitations (32)
Below are a few examples of reports where side effects / adverse reactions may be related to Nuvigil (Armodafinil). For a complete list or a specific selection of reports, please use the links above.
Possible Nuvigil side effects in female
Reported by a physician from United States on 2012-08-24
Patient: female
Reactions: Thrombosis
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: male
Reactions: Abnormal Dreams, Panic Attack, Drug Ineffective, Hallucination
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in 49 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 49 year old female, weighing 59.0 kg (129.7 pounds)
Reactions: Pruritus, Urticaria, Chest Pain, Anaphylactic Shock
Drug(s) suspected as cause:
Nuvigil
Dosage: 1 tablet per day
Indication: Fatigue
Start date: 2011-11-21
Nuvigil
Dosage: 1 tablet per day
Indication: Fatigue
Start date: 2011-11-22
Nuvigil
Dosage: 1 tablet per day
Indication: Fatigue
Start date: 2011-11-23
Possible Nuvigil side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: male
Reactions: Drug Ineffective, Incorrect Dose Administered
Drug(s) suspected as cause:
Nuvigil
Indication: Sleep Apnoea Syndrome
Nuvigil
Dosage: 150 milligram daily;
Administration route: Oral
Indication: Somnolence
Start date: 2012-04-01
Possible Nuvigil side effects in female
Reported by a physician from United States on 2012-08-23
Patient: female
Reactions: Nausea, Rash, Swollen Tongue, Oropharyngeal Pain, Headache
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in male
Reported by a physician from United States on 2012-08-22
Patient: male
Reactions: Drug Abuse
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil 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 Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: female
Reactions: Urticaria, Rash
Drug(s) suspected as cause:
Nuvigil
Dosage: every am
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2012-08-01
Nuvigil
Indication: Narcolepsy
Other drugs received by patient: Xanax; Sertraline Hydrochloride
Possible Nuvigil side effects in female
Reported by a physician from United States on 2012-08-21
Patient: female
Reactions: LIP Swelling, DRY Mouth, Swollen Tongue, Rash
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in 32 year old male
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 32 year old male, weighing 63.5 kg (139.7 pounds)
Reactions: Psychotic Disorder, Depression, Suicidal Ideation
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in
Reported by a physician from United States on 2012-08-20
Patient:
Reactions: Oral Mucosal Blistering
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in female
Reported by a physician from United States on 2012-08-20
Patient: female, weighing 94.4 kg (207.8 pounds)
Reactions: Maternal Exposure During Pregnancy, Abortion Missed, Headache
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Psyllium; Acetaminophen; Bupropion HCL; OB Complete; Pristiq
Possible Nuvigil side effects in female
Reported by a health professional (non-physician/pharmacist) from Uruguay on 2012-08-17
Patient: female
Reactions: Foetal Distress Syndrome, Live Birth, Strabismus, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Methylphenidate Hydrochloride; Fluoxetine Hydrochloride; Pristiq; Pristiq; Obetrol
Possible Nuvigil side effects in female
Reported by a individual with unspecified qualification from United States on 2012-08-16
Patient: female, weighing 2.5 kg (5.5 pounds)
Reactions: Small FOR Dates Baby
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Hydroxychloroquine Sulfate; Axotal; Multi-Vitamins; Vicodin; Excedrin (Migraine); Topiramate; Pilocarpine Hydrochloride; Sertraline Hydrochloride
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: female, weighing 63.6 kg (139.8 pounds)
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Singulair
Possible Nuvigil side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: male
Reactions: Off Label Use, Drug Ineffective
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: male
Reactions: Anxiety, Insomnia, Headache, Lacrimation Increased
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in male
Reported by a physician from United States on 2012-08-16
Patient: male, weighing 2.8 kg (6.1 pounds)
Reactions: Hydrocephalus, Cerebrovascular Disorder
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Ergocalciferol; Multi-Vitamins; Guaifenesin; Acyclovir
Possible Nuvigil side effects in 56 year old female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: 56 year old female, weighing 97.1 kg (213.5 pounds)
Reactions: Weight Increased, Hypopnoea, Rash, Stevens-Johnson Syndrome
Drug(s) suspected as cause:
Ciprofloxacin HCL
Dosage: 0.3 %, unk
Nuvigil
Dosage: 250 mg, qd
Administration route: Oral
Indication: Sleep Apnoea Syndrome
Start date: 2011-10-24
Other drugs received by patient: Mirapex; Atenolol; Aspirin; Crestor; Bupropion Hydrochloride; Citalopram
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: female
Reactions: Off Label Use, Therapeutic Response Unexpected
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in 68 year old male
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: 68 year old male, weighing 86.3 kg (189.8 pounds)
Reactions: Anxiety, Drug Effect Decreased, Chest Discomfort, Insomnia, Pollakiuria, Device Occlusion, Cardiovascular Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nuvigil
Administration route: Oral
Nuvigil
Administration route: Oral
Start date: 2012-04-02
Nuvigil
Administration route: Oral
Indication: Narcolepsy
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: female, weighing 90.8 kg (199.8 pounds)
Reactions: Anxiety
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Buspar; Mirapex; Allegra; Ventolin; Lexapro; Fluticasone Propionate
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: female
Reactions: Off Label Use, Nausea, Insomnia, Headache
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Lomotil; Antihistamines; Thyroid TAB
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: female, weighing 59.0 kg (129.8 pounds)
Reactions: Distractibility, Dyspnoea, Restlessness, Hypotonia, Heart Rate Increased, Disturbance in Attention, Lethargy
Drug(s) suspected as cause:
Nuvigil
Dosage: 75 milligram daily;
Administration route: Oral
Nuvigil
Dosage: 125 milligram daily;
Administration route: Oral
Nuvigil
Dosage: 200 milligram daily;
Administration route: Oral
Nuvigil
Dosage: 250 milligram daily;
Administration route: Oral
Start date: 2012-07-20
Nuvigil
Dosage: 150 milligram daily;
Administration route: Oral
Indication: Narcolepsy
Other drugs received by patient: Xyrem
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: female, weighing 113.5 kg (249.7 pounds)
Reactions: Off Label Use, Therapeutic Response Unexpected
Drug(s) suspected as cause:
Nuvigil
Indication: Cardiac Fibrillation
Nuvigil
Dosage: prn
Administration route: Oral
Indication: Fatigue
Start date: 2012-07-30
Nuvigil
Indication: Encephalitis
Other drugs received by patient: Provigil; Provigil; Provigil; Atenolol
Possible Nuvigil side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: male, weighing 106.7 kg (234.7 pounds)
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in 29 year old male
Reported by a physician from United States on 2012-08-10
Patient: 29 year old male
Reactions: Rash
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Tekturna
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: female, weighing 55.8 kg (122.9 pounds)
Reactions: Off Label Use, Headache
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Multi-Vitamin; Aspirin; Zyrtec; Lipitor
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