Index of reports
> Cases with Off Label Use (53)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Nuvigil (Armodafinil) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 53 Next >>
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 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 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 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 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 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
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: female
Reactions: Off Label Use, Drug Effect Decreased
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-31
Patient: female
Reactions: Mouth Ulceration, Pain, Pyrexia, Tongue Abscess, Off Label Use, Malaise, Fatigue, Asthenia
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Nadolol
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-25
Patient: female
Reactions: Off Label Use, Therapeutic Response Unexpected
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-25
Patient: male
Reactions: Off Label Use, Drug Effect Decreased, Sluggishness
Drug(s) suspected as cause:
Nuvigil
Indication: Somnolence
Nuvigil
Indication: Hypersomnia
Start date: 2009-01-01
Possible Nuvigil side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-21
Patient: female
Reactions: Off Label Use, Drug Ineffective, Feeling Abnormal
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-18
Patient: female
Reactions: Off Label Use, Burns Second Degree, Dysuria
Drug(s) suspected as cause:
Brazillian Laser Hair Removal
Nuvigil
Indication: Vision Blurred
Nuvigil
Dosage: 150 milligram;
Administration route: Oral
Indication: Asthenia
Start date: 2012-07-10
Other drugs received by patient: Avonex; Oral Contraceptive NOS; Vitamin TAB
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: female
Reactions: Off Label Use
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-10
Patient: female, weighing 70.4 kg (154.8 pounds)
Reactions: Off Label Use, Drug Effect Increased, Insomnia, Headache
Drug(s) suspected as cause:
Nuvigil
Indication: Somnolence
Nuvigil
Dosage: q am
Administration route: Oral
Indication: Fatigue
Start date: 2012-07-04
Other drugs received by patient: Lipitor; Soma; Diclofenac Sodium; Protonix; Cymbalta; Soma; Femhrt; Fioricet; Acyclovir
Possible Nuvigil side effects in female
Reported by a physician from United States on 2012-07-03
Patient: female
Reactions: Off Label Use, Skin Lesion, Throat Tightness
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in 34 year old female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: 34 year old female
Reactions: Off Label Use, Therapeutic Response Unexpected
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female, weighing 109.0 kg (239.7 pounds)
Reactions: Off Label Use, Insomnia, Intentional Drug Misuse
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Requip; Tramadol HCL; Citalopram Hydrobromide; Water Pill
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female, weighing 81.7 kg (179.8 pounds)
Reactions: Off Label Use, Drug Ineffective, Somnolence
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Hydrochlorothiazde TAB; Fish OIL; Iron; Biotin; Ergocalciferol; Rabeprazole Sodium; Multi-Vitamins
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female, weighing 52.2 kg (114.9 pounds)
Reactions: Off Label Use, Fatigue, Chest Pain, Paraesthesia, Decreased Appetite
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Glatiramer Acetate; Carvedilol; Meclizine Hydrochloride; Ramipril
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female, weighing 59.0 kg (129.8 pounds)
Reactions: Off Label Use, Drug Effect Decreased
Drug(s) suspected as cause:
Nuvigil
Administration route: Oral
Indication: Fibromyalgia
Start date: 2011-05-01
End date: 2012-02-01
Nuvigil
Indication: Off Label Use
Nuvigil
Administration route: Oral
Indication: Fatigue
Start date: 2012-02-01
End date: 2012-04-01
Other drugs received by patient: Duloxetine Hydrochloride; Fentanyl Citrate; Thyroid TAB; Bupropion HCL
Possible Nuvigil side effects in 35 year old female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: 35 year old female
Reactions: Off Label Use, Overdose, Dependence
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female
Reactions: Anxiety, Off Label Use, Drug Tolerance
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Escitalopram; Escitalopram
Possible Nuvigil side effects in 35 year old female
Reported by a physician from United States on 2012-07-03
Patient: 35 year old female
Reactions: Off Label Use, Intentional Drug Misuse, Rash, Blister
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female
Reactions: Off Label Use, Incorrect Dose Administered, Feeling Jittery, Nervousness
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03
Patient: 33 year old female
Reactions: Off Label Use, Rash
Drug(s) suspected as cause:
Nuvigil
Possible Nuvigil side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: male
Reactions: Off Label Use, Drug Ineffective
Drug(s) suspected as cause:
Modafinil
Administration route: Oral
Indication: Fatigue
Nuvigil
Administration route: Oral
Indication: Fatigue
Other drugs received by patient: Levothyroxine Sodium
Possible Nuvigil side effects in female
Reported by a physician from United States on 2012-07-03
Patient: female, weighing 52.2 kg (114.9 pounds)
Reactions: Pruritus Generalised, Off Label Use, Dyspnoea, Swelling Face, Pharyngeal Oedema, Oedema Peripheral, Anaphylactic Shock
Drug(s) suspected as cause:
Nuvigil
Indication: Disturbance in Attention
Nuvigil
Dosage: 150 milligram;
Administration route: Oral
Indication: Sleep Disorder
End date: 2012-02-22
Other drugs received by patient: Duloxetine Hydrochloride; Acetaminophen; Duloxetine Hydrochloride; Norlestrin FE
Possible Nuvigil side effects in male
Reported by a physician from United States on 2012-07-03
Patient: male, weighing 76.3 kg (167.8 pounds)
Reactions: Off Label Use, Inappropriate Schedule of Drug Administration, Rash Pruritic
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Curcumin; Imipramine HCL; Avodart; Milk Thistle; Aspirin; Quercetin; Resveratrol; Ascorbic Acid; Mega Green TEA; SOY Isoflavin; Mega Lycopene; Ritalin; Fish OIL; Lecithin
Possible Nuvigil side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: male, weighing 70.4 kg (154.8 pounds)
Reactions: Off Label Use, Dyspnoea
Drug(s) suspected as cause:
Nuvigil
Other drugs received by patient: Zolpidem Tartrate; Carbamazepine; Lorazepam
Possible Nuvigil side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female, weighing 74.9 kg (164.8 pounds)
Reactions: Off Label Use, Apathy, Somnolence
Drug(s) suspected as cause:
Nuvigil
Dosage: 150 milligram;
Administration route: Oral
Indication: Depression
Nuvigil
Indication: Fatigue
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