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Vimovo (Esomeprazole / Naproxen) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vimovo (Esomeprazole / Naproxen) 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 (326)
Death (7)
Life Threatening Events (16)
Disability (1)

Reports by Reaction Type

Drug Dose Omission (34)Pain (33)Off Label Use (26)Arthritis (22)Abdominal Discomfort (18)Malaise (18)Drug Ineffective (15)Arthralgia (14)Gastrooesophageal Reflux Disease (12)Dyspnoea (12)Pain in Extremity (12)Dizziness (11)

Below are a few examples of reports where side effects / adverse reactions may be related to Vimovo (Esomeprazole / Naproxen). For a complete list or a specific selection of reports, please use the links above.

Possible Vimovo side effects in 61 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 61 year old female

Reactions: Adverse Event

Drug(s) suspected as cause:
Crestor
    Administration route: Oral

Symbicort

Vimovo
    Administration route: Oral

Other drugs received by patient: Fish OIL; Multivitamin; Ventolin; Synthroid; Triamterene; Nexium; Bisoprolol Fumarate; Calcium; Dicyclomine; Meclizine HCL



Possible Vimovo side effects in 85 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 85 year old female

Reactions: Renal Disorder, Diarrhoea, Sinus Disorder, Adverse Drug Reaction

Drug(s) suspected as cause:
Vimovo
    Administration route: Oral

Vimovo
    Administration route: Oral



Possible Vimovo side effects in 42 year old female

Reported by a physician from United Kingdom on 2012-08-24

Patient: 42 year old female

Reactions: Amenorrhoea

Drug(s) suspected as cause:
Vimovo

Other drugs received by patient: Norinyl 1+35 28-DAY; Tramadol HCL; Gabapentin



Possible Vimovo side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 59 year old female

Reactions: Abdominal Discomfort, Regurgitation, Fibromyalgia, Bone Pain, Rotator Cuff Syndrome

Drug(s) suspected as cause:
Prilosec OTC
    Administration route: Oral

Symbicort

Vimovo
    Administration route: Oral



Possible Vimovo side effects in 56 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 56 year old female

Reactions: Inappropriate Schedule of Drug Administration, Malaise, Chest Discomfort, Throat Irritation, Chronic Obstructive Pulmonary Disease, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Nexium
    Dosage: two capsules
    Administration route: Oral

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2000-01-01

Nexium
    Administration route: Oral

Reglan

Symbicort
    Dosage: 320 two times a day
    Indication: Chronic Obstructive Pulmonary Disease

Vimovo
    Dosage: 500 mg / 20 mg two times a day
    Administration route: Oral
    Indication: Arthritis
    Start date: 2011-07-01
    End date: 2011-08-01

Other drugs received by patient: Spiriva; Levothyroxine Sodium; Oxycont; Zyrtec; Vistaril; Claritin; Lisinopril; Clonidine; Xanax; Celexa; Lovastatin



Possible Vimovo side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 49 year old female

Reactions: Nodule, Infection

Drug(s) suspected as cause:
Pulmicort Flexhaler

Symbicort

Vimovo
    Administration route: Oral



Possible Vimovo side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female

Reactions: Fungal Infection

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in female

Reported by a physician from Ireland on 2012-08-20

Patient: female, weighing 59.3 kg (130.5 pounds)

Reactions: Intestinal Haemorrhage, Pneumonia, Intestinal Perforation, Respiratory Failure

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Vimovo

Other drugs received by patient: Fluticasone Propionate / Salmeterol; Noctamid; Maxidex; Levothyroxine Sodium; Indapamide; Sertraline Hydrochloride; Diazepam; Aqueous Cream; Gaviscon; Feldene; Tiotropium; Albuterol; Rosuvastatin; Perindopril Erbumine; Sertraline Hydrochloride



Possible Vimovo side effects in male

Reported by a physician from Ireland on 2012-08-20

Patient: male

Reactions: Multi-Organ Failure, Pancreatic Carcinoma, Liver Function Test Abnormal, Renal Failure Acute, Blood Test Abnormal

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vimovo

Other drugs received by patient: Laxatine; Akineton; Risperdal; Lipitor; Metformin HCL; Depixol; Onglyza



Possible Vimovo side effects in 78 year old female

Reported by a physician from Hungary on 2012-08-20

Patient: 78 year old female

Reactions: Dysgeusia, DRY Mouth

Drug(s) suspected as cause:
Vimovo

Other drugs received by patient: Xanax; Kalium; Berodual; Nitro-DUR; Furosemide; Syncumar; Allopurinol; Lendormin; Adexor; Sertadel; Theospirex



Possible Vimovo side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 56 year old female, weighing 98.0 kg (215.6 pounds)

Reactions: Breast Cancer

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 54 year old female

Reactions: Feeling Abnormal, Arthritis

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Pain Shot

Vimovo
    Administration route: Oral



Possible Vimovo side effects in 78 year old female

Reported by a physician from Belgium on 2012-08-16

Patient: 78 year old female, weighing 72.9 kg (160.4 pounds)

Reactions: Hallucination, Auditory, Pain in Extremity

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lormetazepame

Vimovo
    Administration route: Oral

Other drugs received by patient: Clonazepam; Praxilene; Ibuprofen; Redomex; Risperdal; Perindopril Erbumine; Vasexten; Bisoprolol Fumarate and Hydrochlorothiazide; Indapamide; Indapamide



Possible Vimovo side effects in 78 year old female

Reported by a physician from Hungary on 2012-08-15

Patient: 78 year old female

Reactions: Dysgeusia, DRY Mouth

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in 67 year old male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: 67 year old male

Reactions: Adverse Event, Dislocation of Vertebra

Drug(s) suspected as cause:
Nexium
    Administration route: Oral

Toprol-XL
    Administration route: Oral

Vimovo
    Administration route: Oral



Possible Vimovo side effects in 42 year old female

Reported by a pharmacist from United Kingdom on 2012-08-13

Patient: 42 year old female

Reactions: Amenorrhoea, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Vimovo

Other drugs received by patient: Norinyl 1+35 28-DAY; Gabapentin; Tramadol HCL



Possible Vimovo side effects in 82 year old female

Reported by a consumer/non-health professional from Canada on 2012-08-09

Patient: 82 year old female

Reactions: Eye Haemorrhage

Drug(s) suspected as cause:
Vimovo

Other drugs received by patient: Tramadol HCL



Possible Vimovo side effects in 53 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 53 year old female

Reactions: Adverse Drug Reaction

Drug(s) suspected as cause:
Vimovo

Other drugs received by patient: Seroquel XR



Possible Vimovo side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 38 year old female

Reactions: Drug Dose Omission, Arthralgia

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in

Reported by a physician from United States on 2012-08-08

Patient:

Reactions: Pain

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 69 year old female

Reactions: Thrombosis, Therapeutic Response Unexpected, Adverse Drug Reaction, Hyperhidrosis, Cardiac Disorder, Malaise, Blood Electrolytes Abnormal, Blood Cholesterol Increased, Heart Rate Irregular, Cough, Hypersomnia, Diabetes Mellitus Inadequate Control, Hypotension, Blood Potassium Increased, Atrial Fibrillation, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Administration route: Oral

Metoprolol Tartrate

Toprol-XL
    Administration route: Oral

Toprol-XL
    Administration route: Oral

Vimovo
    Administration route: Oral

Other drugs received by patient: Lasix



Possible Vimovo side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 70 year old male

Reactions: Arthritis

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in 43 year old female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: 43 year old female

Reactions: Drug Dose Omission, Musculoskeletal Pain, Joint Injury, Inflammation

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in 42 year old female

Reported by a pharmacist from Canada on 2012-08-01

Patient: 42 year old female

Reactions: Tinnitus, Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vimovo

Other drugs received by patient: Marvelon 28; Lyrica



Possible Vimovo side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Laboratory Test Abnormal, Hormone Level Abnormal, Infertility

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in 43 year old female

Reported by a physician from Spain on 2012-08-01

Patient: 43 year old female

Reactions: Eyelid Oedema, Dyspnoea, Urticaria, Oedema Peripheral

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in 46 year old male

Reported by a physician from Philippines on 2012-08-01

Patient: 46 year old male

Reactions: Renal Tubular Disorder, Hyperkalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in male

Reported by a physician from United States on 2012-07-30

Patient: male

Reactions: Ulcer

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 63 year old female

Reactions: Arthritis

Drug(s) suspected as cause:
Vimovo



Possible Vimovo side effects in 79 year old female

Reported by a physician from United States on 2012-07-30

Patient: 79 year old female

Reactions: Anaemia, Renal Failure Acute

Drug(s) suspected as cause:
Vimovo

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