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Nuvigil (Armodafinil) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



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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