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Nuvigil (Armodafinil) - Side Effect Reports to FDA

 
 



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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