Index of reports
> Cases with Off Label Use (26)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vimovo (Esomeprazole / Naproxen) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Vimovo side effects in 48 year old male
Reported by a physician from United States on 2012-07-18
Patient: 48 year old male, weighing 90.7 kg (199.5 pounds)
Reactions: Off Label Use, Hiccups
Drug(s) suspected as cause:
Vimovo
Administration route: Oral
Indication: Arthralgia
Vimovo
Administration route: Oral
Indication: Tendonitis
Possible Vimovo side effects in 82 year old female
Reported by a individual with unspecified qualification from United States on 2012-06-25
Patient: 82 year old female
Reactions: Drug Intolerance, Drug Hypersensitivity, Off Label Use, Limb Discomfort, Muscle Disorder, Arthritis, Mobility Decreased, Muscle Spasms
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Start date: 2010-01-01
Crestor
Administration route: Oral
Vimovo
Dosage: 500 mg naproxen + 20 mg esomeprazole magnesium
Administration route: Oral
Possible Vimovo side effects in 63 year old male
Reported by a pharmacist from Ireland on 2012-06-25
Patient: 63 year old male
Reactions: Off Label Use, Idiopathic Thrombocytopenic Purpura
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Vimovo
Other drugs received by patient: Steroids
Possible Vimovo side effects in male
Reported by a physician from United States on 2012-06-07
Patient: male
Reactions: Off Label Use, Hiccups
Drug(s) suspected as cause:
Vimovo
Possible Vimovo side effects in 63 year old male
Reported by a pharmacist from Ireland on 2012-05-16
Patient: 63 year old male
Reactions: Off Label Use, Idiopathic Thrombocytopenic Purpura
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Vimovo
Other drugs received by patient: Steroids
Possible Vimovo side effects in 63 year old male
Reported by a pharmacist from Ireland on 2012-05-15
Patient: 63 year old male
Reactions: Off Label Use, Idiopathic Thrombocytopenic Purpura
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Vimovo
Other drugs received by patient: Steroids
Possible Vimovo side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-07
Patient: female
Reactions: Off Label Use, Reaction To Drug Excipients
Drug(s) suspected as cause:
Vimovo
Dosage: 500/20 mg
Administration route: Oral
Indication: Arthralgia
Start date: 2012-02-01
Vimovo
Dosage: 500/20 mg
Administration route: Oral
Indication: Muscle Disorder
Start date: 2012-02-01
Possible Vimovo side effects in 40 year old female
Reported by a physician from United States on 2012-05-07
Patient: 40 year old female
Reactions: Inappropriate Schedule of Drug Administration, Off Label Use, Pigmentation Disorder
Drug(s) suspected as cause:
Vimovo
Dosage: 500 mg/20 mg, as needed or every other day once daily
Administration route: Oral
Indication: Ear Pain
Vimovo
Dosage: 500 mg/20 mg, as needed or every other day once daily
Administration route: Oral
Indication: Neck Pain
Possible Vimovo side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-07
Patient: female
Reactions: Off Label Use, Oedema Peripheral, Arthritis, Inflammation
Drug(s) suspected as cause:
Vimovo
Possible Vimovo side effects in 26 year old female
Reported by a physician from United States on 2012-05-07
Patient: 26 year old female, weighing 95.3 kg (209.7 pounds)
Reactions: Off Label Use, Swelling, Urticaria
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vimovo
Dosage: 375 mg / 20 mg, two times a day
Administration route: Oral
Indication: Abdominal Pain
Vimovo
Dosage: 500 mg / 20 mg, two times a day
Administration route: Oral
Possible Vimovo side effects in 55 year old female
Reported by a consumer/non-health professional from United States on 2012-04-09
Patient: 55 year old female, weighing 97.1 kg (213.6 pounds)
Reactions: Off Label Use, Foot Fracture, Drug Ineffective, Therapeutic Response Unexpected, Somnolence, Asthenia
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Lisinopril
Administration route: Oral
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Indication: Migraine
Start date: 2000-01-01
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Indication: Depression
Start date: 2000-01-01
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Indication: Anxiety
Start date: 2000-01-01
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Seroquel XR
Administration route: Oral
Indication: Sleep Disorder
Start date: 2000-01-01
Seroquel XR
Administration route: Oral
Toprol-XL
Administration route: Oral
Vimovo
Administration route: Oral
Other drugs received by patient: Roxicodone; Hydroxyzine HCL; Esgic-Plus; Beprede; Benadryl; Compazine; Zofran; Folic Acid; Prodrin; Vitamin D; Prednisone; Xyzal; Lasix; Sonata; Methotrexate; Amitiza; Omnaris; Dexilant; Estradiol; Sumavel Dosepro; Sumatriptan; Sumatriptan; Tessalon; Cymbalta; Remicade; Treximet; Celexa; Pepsid; Topamax
Possible Vimovo side effects in 88 year old female
Reported by a physician from NEW Zealand on 2012-03-22
Patient: 88 year old female
Reactions: Off Label Use, Urinary Tract Infection, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vimovo
Other drugs received by patient: Naprosyn; Codeine; Fentanyl; Amitriptyline HCL; DHC; Gabapentin
Possible Vimovo side effects in female
Reported by a physician from United States on 2012-02-24
Patient: female
Reactions: Off Label Use, Arthritis
Drug(s) suspected as cause:
Vimovo
Possible Vimovo side effects in 61 year old female
Reported by a individual with unspecified qualification from United States on 2012-02-24
Patient: 61 year old female, weighing 70.8 kg (155.8 pounds)
Reactions: Off Label Use, Arthralgia, Joint Effusion, Finger Deformity
Drug(s) suspected as cause:
Vimovo
Other drugs received by patient: Comcigan; Methrotrexate; Leucovorin Calcium; Premarin; Imipramine; Carbamazepine; Lorazepam
Possible Vimovo side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-24
Patient: female
Reactions: Off Label Use, Incorrect Dose Administered, Feeling Abnormal
Drug(s) suspected as cause:
Vimovo
Dosage: 500 mg/20 mg, daily
Administration route: Oral
Indication: Myalgia
Vimovo
Dosage: 500 mg/20 mg, daily
Administration route: Oral
Indication: Arthritis
Possible Vimovo side effects in 40 year old female
Reported by a physician from United States on 2012-02-24
Patient: 40 year old female
Reactions: Inappropriate Schedule of Drug Administration, Off Label Use, Pigmentation Disorder
Drug(s) suspected as cause:
Vimovo
Dosage: 500 mg/20 mg, as needed or every other day once daily
Administration route: Oral
Indication: Neck Pain
Vimovo
Dosage: 500 mg/20 mg, as needed or every other day once daily
Administration route: Oral
Indication: Ear Pain
Possible Vimovo side effects in 26 year old female
Reported by a physician from United States on 2012-02-24
Patient: 26 year old female, weighing 95.3 kg (209.7 pounds)
Reactions: Off Label Use, Swelling, Urticaria
Drug(s) suspected as cause:
Vimovo
Possible Vimovo side effects in female
Reported by a physician from Spain on 2012-02-06
Patient: female
Reactions: Off Label Use, Anaphylactic Shock
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vimovo
Other drugs received by patient: Moxifloxacin
Possible Vimovo side effects in 44 year old male
Reported by a consumer/non-health professional from United States on 2011-11-29
Patient: 44 year old male, weighing 104.3 kg (229.5 pounds)
Reactions: Off Label Use, Dyspepsia, Flatulence, Pollakiuria, Gastric Disorder, Faeces Discoloured
Drug(s) suspected as cause:
Vimovo
Other drugs received by patient: Lisinopril
Possible Vimovo side effects in 80 year old female
Reported by a consumer/non-health professional from United States on 2011-11-29
Patient: 80 year old female, weighing 38.6 kg (84.9 pounds)
Reactions: Weight Increased, Off Label Use, Therapeutic Response Unexpected
Drug(s) suspected as cause:
Vimovo
Dosage: 500 mg/ 20 mg bid
Administration route: Oral
Indication: Convulsion
Start date: 2011-05-01
Vimovo
Dosage: 500 mg/ 20 mg bid
Administration route: Oral
Indication: Arthritis
Start date: 2011-05-01
Possible Vimovo side effects in 17 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-29
Patient: 17 year old female
Reactions: Off Label Use, Fatigue, Somnolence
Drug(s) suspected as cause:
Vimovo
Possible Vimovo side effects in 46 year old female
Reported by a individual with unspecified qualification from United States on 2011-11-29
Patient: 46 year old female
Reactions: Off Label Use, Constipation
Drug(s) suspected as cause:
Vimovo
Possible Vimovo side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-29
Patient: female
Reactions: Rheumatoid Arthritis, Off Label Use
Drug(s) suspected as cause:
Vimovo
Possible Vimovo side effects in 60 year old male
Reported by a consumer/non-health professional from United States on 2011-11-29
Patient: 60 year old male
Reactions: Off Label Use, Dizziness
Drug(s) suspected as cause:
Crestor
Administration route: Oral
Indication: Blood Cholesterol Increased
Vimovo
Dosage: 500 mg / 20mg prn
Administration route: Oral
Start date: 2011-06-08
Possible Vimovo side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-29
Patient: female
Reactions: Asthma, Off Label Use, Chest Pain, Contraindication To Medical Treatment
Drug(s) suspected as cause:
Vimovo
Other drugs received by patient: Topiramate; Singulair; Vitamin E; Birth Control Pills
Possible Vimovo side effects in 65 year old female
Reported by a physician from United States on 2011-11-29
Patient: 65 year old female
Reactions: Off Label Use, Vomiting, Muscle Spasms
Drug(s) suspected as cause:
Vimovo
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