Drug information for VIMOVO

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, DELAYED RELEASE; ORAL EQ 20MG BASE;375MG Prescription   ESOMEPRAZOLE MAGNESIUM; NAPROXEN Omeprazole ASTRAZENECA LP 22511
2012-02-03 Other
2012-01-24 Label
2012-01-23 Letter
2011-12-20 Other Important Information from FDA
2011-11-29 Label
2011-11-29 Medication Guide
2011-11-22 Letter
2011-06-29 Label
2011-06-29 Label
2011-06-29 Medication Guide
2011-06-29 Medication Guide
2011-06-29 Letter
2011-06-29 Letter
2011-05-26 Label
2011-05-26 Medication Guide
2011-05-25 Letter
2011-02-28 Review
2011-02-28 Summary Review
2010-05-07 Label
2010-05-07 Medication Guide
2010-05-07 Letter
TABLET, DELAYED RELEASE; ORAL EQ 20MG BASE;500MG Prescription  (Reference Drug) ESOMEPRAZOLE MAGNESIUM; NAPROXEN Omeprazole ASTRAZENECA LP   "

Drug Adverse Effects information for VIMOVO

Role code Indications Reaction # Reports
PS ARTHRALGIA ATAXIA 1
PS ARTHRALGIA CONSTIPATION 1
PS ARTHRALGIA DYSPEPSIA 1
PS ARTHRALGIA FAECES DISCOLOURED 1
PS ARTHRALGIA FLATULENCE 1
PS ARTHRALGIA GASTRIC DISORDER 1
PS ARTHRALGIA OFF LABEL USE 2
PS ARTHRALGIA POLLAKIURIA 1
PS ARTHRALGIA RENAL FAILURE ACUTE 1
PS ARTHRALGIA SOMNOLENCE 1
PS ARTHRITIS ABDOMINAL DISCOMFORT 1
PS ARTHRITIS ABDOMINAL PAIN UPPER 1
PS ARTHRITIS BLISTER 1
PS ARTHRITIS BURN OESOPHAGEAL 1
PS ARTHRITIS DIARRHOEA 1
PS ARTHRITIS MEMORY IMPAIRMENT 1
PS ARTHRITIS OFF LABEL USE 1
PS ARTHRITIS RASH 2
PS ARTHRITIS THERAPEUTIC RESPONSE UNEXPECTED 1
PS ARTHRITIS WEIGHT INCREASED 1
PS BACK PAIN FATIGUE 1
PS BACK PAIN OFF LABEL USE 1
PS BACK PAIN SOMNOLENCE 1
PS BLOOD CHOLESTEROL ABDOMINAL DISCOMFORT 1
PS BLOOD CHOLESTEROL TREATMENT NONCOMPLIANCE 1
PS BLOOD CHOLESTEROL INCREASED DIZZINESS 1
PS BLOOD CHOLESTEROL INCREASED OFF LABEL USE 1
PS BLOOD PRESSURE ABDOMINAL DISCOMFORT 2
PS BLOOD PRESSURE TREATMENT NONCOMPLIANCE 2
PS BLOOD PRESSURE ABNORMAL DYSPEPSIA 1
PS BLOOD PRESSURE ABNORMAL FAECES DISCOLOURED 1
PS BLOOD PRESSURE ABNORMAL FLATULENCE 1
PS BLOOD PRESSURE ABNORMAL GASTRIC DISORDER 1
PS BLOOD PRESSURE ABNORMAL OFF LABEL USE 1
PS BLOOD PRESSURE ABNORMAL POLLAKIURIA 1
PS BRONCHITIS ARRHYTHMIA 1
PS BRONCHITIS CAROTID ARTERY STENOSIS 1
PS BRONCHITIS COUGH 1
PS BRONCHITIS DRUG HYPERSENSITIVITY 1
PS BRONCHITIS DYSPEPSIA 1
PS BRONCHITIS FATIGUE 1
PS BRONCHITIS GASTROOESOPHAGEAL REFLUX DISEASE 1
PS BRONCHITIS HEADACHE 1
PS BRONCHITIS HEART RATE INCREASED 1
PS BRONCHITIS HYPERTENSION 1
PS BRONCHITIS LYMPHADENOPATHY 1
PS BRONCHITIS MITRAL VALVE INCOMPETENCE 1
PS BRONCHITIS NAUSEA 1
PS BRONCHITIS NON-CARDIAC CHEST PAIN 1
PS BRONCHITIS OROPHARYNGEAL PAIN 1
PS BRONCHITIS PALPITATIONS 1
PS BRONCHITIS RHINORRHOEA 1
PS BRONCHITIS SYNCOPE 1
PS CARPAL TUNNEL SYNDROME DRUG PRESCRIBING ERROR 1
PS CARPAL TUNNEL SYNDROME GASTROINTESTINAL HAEMORRHAGE 1
PS CHEST PAIN ARRHYTHMIA 1
PS CHEST PAIN CAROTID ARTERY STENOSIS 1
PS CHEST PAIN COUGH 1
PS CHEST PAIN DRUG HYPERSENSITIVITY 1
PS CHEST PAIN DYSPEPSIA 1
PS CHEST PAIN FATIGUE 1
PS CHEST PAIN GASTROOESOPHAGEAL REFLUX DISEASE 1
PS CHEST PAIN HEADACHE 1
PS CHEST PAIN HEART RATE INCREASED 1
PS CHEST PAIN HYPERTENSION 1
PS CHEST PAIN LYMPHADENOPATHY 1
PS CHEST PAIN MITRAL VALVE INCOMPETENCE 1
PS CHEST PAIN NAUSEA 1
PS CHEST PAIN NON-CARDIAC CHEST PAIN 1
PS CHEST PAIN OROPHARYNGEAL PAIN 1
PS CHEST PAIN PALPITATIONS 1
PS CHEST PAIN RHINORRHOEA 1
PS CHEST PAIN SYNCOPE 1
PS CONVULSION OFF LABEL USE 1
PS CONVULSION THERAPEUTIC RESPONSE UNEXPECTED 1
PS CONVULSION WEIGHT INCREASED 1
PS DEPRESSION FALL 1
PS DEPRESSION RENAL FAILURE ACUTE 1
PS DYSMENORRHOEA ASTHMA 1
PS DYSMENORRHOEA CHEST PAIN 1
PS DYSMENORRHOEA CONTRAINDICATION TO MEDICAL TREATMENT 1
PS DYSMENORRHOEA OFF LABEL USE 1
PS FIBROMYALGIA ATRIAL FIBRILLATION 2
PS FIBROMYALGIA BLOOD CREATININE INCREASED 2
PS FIBROMYALGIA BLOOD POTASSIUM INCREASED 2
PS FIBROMYALGIA DIAPHRAGMALGIA 2
PS FIBROMYALGIA DRUG INTERACTION 2
PS FIBROMYALGIA HEART RATE DECREASED 2
PS FIBROMYALGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS FIBROMYALGIA RENAL FAILURE ACUTE 2
PS FUNGAL INFECTION ABDOMINAL DISCOMFORT 1
PS FUNGAL INFECTION ARTHRITIS 1
PS FUNGAL INFECTION BEHCET'S SYNDROME 1
PS FUNGAL INFECTION FIBROMYALGIA 1
PS FUNGAL INFECTION RHEUMATOID ARTHRITIS 1
PS FUNGAL INFECTION TOTAL LUNG CAPACITY DECREASED 1
PS FUNGAL INFECTION VISUAL FIELD DEFECT 1
PS GOUT OFF LABEL USE 1
PS GOUT RHEUMATOID ARTHRITIS 1
PS HEADACHE DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 1
PS HEADACHE HEADACHE 1
PS HIP FRACTURE ANAPHYLACTIC REACTION 1
PS HIP FRACTURE BLOOD CREATININE DECREASED 1
PS HIP FRACTURE BLOOD UREA DECREASED 1
PS HIP FRACTURE CONFUSIONAL STATE 1
PS HIP FRACTURE HAEMORRHAGE 1
PS HIP FRACTURE HYPOTENSION 1
PS HIP FRACTURE LOSS OF CONSCIOUSNESS 1
PS HORMONE THERAPY BLISTER 1
PS HORMONE THERAPY HYPERSENSITIVITY 1
PS HORMONE THERAPY PRURITUS 1
PS HYPERLIPIDAEMIA ARRHYTHMIA 1
PS HYPERLIPIDAEMIA CAROTID ARTERY STENOSIS 1
PS HYPERLIPIDAEMIA COUGH 1
PS HYPERLIPIDAEMIA DRUG HYPERSENSITIVITY 1
PS HYPERLIPIDAEMIA DYSPEPSIA 1
PS HYPERLIPIDAEMIA FATIGUE 1
PS HYPERLIPIDAEMIA GASTROOESOPHAGEAL REFLUX DISEASE 1
PS HYPERLIPIDAEMIA HEADACHE 1
PS HYPERLIPIDAEMIA HEART RATE INCREASED 1
PS HYPERLIPIDAEMIA HYPERTENSION 1
PS HYPERLIPIDAEMIA LYMPHADENOPATHY 1
PS HYPERLIPIDAEMIA MITRAL VALVE INCOMPETENCE 1
PS HYPERLIPIDAEMIA NAUSEA 1
PS HYPERLIPIDAEMIA NON-CARDIAC CHEST PAIN 1
PS HYPERLIPIDAEMIA OROPHARYNGEAL PAIN 1
PS HYPERLIPIDAEMIA PALPITATIONS 1
PS HYPERLIPIDAEMIA RHINORRHOEA 1
PS HYPERLIPIDAEMIA SYNCOPE 1
PS HYPERTENSION ARRHYTHMIA 1
PS HYPERTENSION BLOOD PRESSURE INCREASED 1
PS HYPERTENSION DIARRHOEA 1
PS HYPERTENSION DIZZINESS 1
PS HYPERTENSION DRUG DOSE OMISSION 1
PS HYPERTENSION FEELING JITTERY 1
PS HYPERTENSION MUSCLE SPASMS 1
PS HYPERTENSION NERVOUSNESS 1
PS HYPERTENSION PAIN 1
PS MULTIPLE SCLEROSIS MUSCLE SPASMS 1
PS MULTIPLE SCLEROSIS OFF LABEL USE 1
PS MULTIPLE SCLEROSIS VOMITING 1
PS MUSCLE SPASMS ARRHYTHMIA 1
PS MUSCLE SPASMS CAROTID ARTERY STENOSIS 1
PS MUSCLE SPASMS COUGH 1
PS MUSCLE SPASMS DRUG HYPERSENSITIVITY 1
PS MUSCLE SPASMS DYSPEPSIA 1
PS MUSCLE SPASMS FATIGUE 1
PS MUSCLE SPASMS GASTROOESOPHAGEAL REFLUX DISEASE 1
PS MUSCLE SPASMS HEADACHE 1
PS MUSCLE SPASMS HEART RATE INCREASED 1
PS MUSCLE SPASMS HYPERTENSION 1
PS MUSCLE SPASMS LYMPHADENOPATHY 1
PS MUSCLE SPASMS MITRAL VALVE INCOMPETENCE 1
PS MUSCLE SPASMS NAUSEA 1
PS MUSCLE SPASMS NON-CARDIAC CHEST PAIN 1
PS MUSCLE SPASMS OROPHARYNGEAL PAIN 1
PS MUSCLE SPASMS PALPITATIONS 1
PS MUSCLE SPASMS RHINORRHOEA 1
PS MUSCLE SPASMS SYNCOPE 1
PS MUSCULOSKELETAL PAIN FALL 1
PS MUSCULOSKELETAL PAIN RENAL FAILURE ACUTE 1
PS NAUSEA ABDOMINAL DISCOMFORT 1
PS NAUSEA ARTHRITIS 1
PS NAUSEA BEHCET'S SYNDROME 1
PS NAUSEA FIBROMYALGIA 1
PS NAUSEA RHEUMATOID ARTHRITIS 1
PS NAUSEA TOTAL LUNG CAPACITY DECREASED 1
PS NAUSEA VISUAL FIELD DEFECT 1
PS NECK PAIN DIPLOPIA 1
PS NECK PAIN DIZZINESS 1
PS NECK PAIN FEELING ABNORMAL 1
PS NECK PAIN GAIT DISTURBANCE 1
PS OEDEMA RENAL FAILURE ACUTE 1
PS OSTEOARTHRITIS ABDOMINAL DISCOMFORT 1
PS OSTEOARTHRITIS ARRHYTHMIA 1
PS OSTEOARTHRITIS BLOOD PRESSURE INCREASED 2
PS OSTEOARTHRITIS CONTUSION 1
PS OSTEOARTHRITIS DIZZINESS 1
PS OSTEOARTHRITIS DRUG INEFFECTIVE 1
PS OSTEOARTHRITIS DUODENAL ULCER 1
PS OSTEOARTHRITIS ENDOSCOPY GASTROINTESTINAL 1
PS OSTEOARTHRITIS EPISTAXIS 1
PS OSTEOARTHRITIS FEELING HOT 1
PS OSTEOARTHRITIS FEELING JITTERY 1
PS OSTEOARTHRITIS FLUSHING 1
PS OSTEOARTHRITIS INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS OSTEOARTHRITIS MUSCLE SPASMS 1
PS OSTEOARTHRITIS NECK PAIN 1
PS OSTEOARTHRITIS NERVOUSNESS 1
PS OSTEOARTHRITIS NIPPLE PAIN 1
PS OSTEOARTHRITIS PAIN IN EXTREMITY 1
PS OSTEOARTHRITIS PLATELET COUNT INCREASED 1
PS OSTEOARTHRITIS PRURITUS 1
PS OSTEOARTHRITIS SOMNOLENCE 1
PS OSTEOARTHRITIS TREATMENT NONCOMPLIANCE 1
PS PAIN ABDOMINAL DISCOMFORT 1
PS PAIN ABDOMINAL PAIN 1
PS PAIN APHONIA 1
PS PAIN ARRHYTHMIA 1
PS PAIN ARTHRITIS 1
PS PAIN ASTHENIA 1
PS PAIN ATRIAL FIBRILLATION 3
PS PAIN BACK DISORDER 1
PS PAIN BACK PAIN 1
PS PAIN BEHCET'S SYNDROME 1
PS PAIN BLOOD CREATININE INCREASED 3
PS PAIN BLOOD POTASSIUM INCREASED 3
PS PAIN CARDIAC FAILURE CONGESTIVE 1
PS PAIN CAROTID ARTERY STENOSIS 1
PS PAIN COUGH 1
PS PAIN DECREASED APPETITE 1
PS PAIN DIAPHRAGMALGIA 3
PS PAIN DRUG HYPERSENSITIVITY 1
PS PAIN DRUG INEFFECTIVE 1
PS PAIN DRUG INTERACTION 3
PS PAIN DYSPEPSIA 1
PS PAIN DYSPNOEA 1
PS PAIN FATIGUE 1
PS PAIN FIBROMYALGIA 1
PS PAIN GASTROOESOPHAGEAL REFLUX DISEASE 1
PS PAIN GENERALISED OEDEMA 1
PS PAIN HEADACHE 1
PS PAIN HEART RATE DECREASED 3
PS PAIN HEART RATE INCREASED 1
PS PAIN HEART RATE IRREGULAR 1
PS PAIN HERPES ZOSTER 1
PS PAIN HYPERTENSION 2
PS PAIN HYPOAESTHESIA 1
PS PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS PAIN INFLUENZA 1
PS PAIN LARYNGITIS 1
PS PAIN LYMPHADENOPATHY 1
PS PAIN MALAISE 1
PS PAIN MITRAL VALVE INCOMPETENCE 1
PS PAIN NAUSEA 1
PS PAIN NON-CARDIAC CHEST PAIN 1
PS PAIN OESOPHAGEAL DISORDER 1
PS PAIN OROPHARYNGEAL PAIN 1
PS PAIN PAIN 1
PS PAIN PALPITATIONS 1
PS PAIN PARAESTHESIA 1
PS PAIN POST HERPETIC NEURALGIA 1
PS PAIN RASH PAPULAR 1
PS PAIN RENAL FAILURE ACUTE 2
PS PAIN RHEUMATOID ARTHRITIS 2
PS PAIN RHINORRHOEA 1
PS PAIN SYNCOPE 1
PS PAIN TOTAL LUNG CAPACITY DECREASED 1
PS PAIN VISUAL FIELD DEFECT 1
PS PAIN WEIGHT DECREASED 1
PS PAIN IN EXTREMITY DIPLOPIA 1
PS PAIN IN EXTREMITY DIZZINESS 1
PS PAIN IN EXTREMITY FEELING ABNORMAL 1
PS PAIN IN EXTREMITY GAIT DISTURBANCE 1
PS PNEUMONITIS BLISTER 1
PS PNEUMONITIS HYPERSENSITIVITY 1
PS PNEUMONITIS PRURITUS 1
PS POLYMYALGIA RHEUMATICA CONSTIPATION 2
PS POLYMYALGIA RHEUMATICA MUSCULOSKELETAL PAIN 2
PS RHEUMATOID ARTHRITIS ABDOMINAL PAIN 1
PS RHEUMATOID ARTHRITIS ARRHYTHMIA 1
PS RHEUMATOID ARTHRITIS CAROTID ARTERY STENOSIS 1
PS RHEUMATOID ARTHRITIS COUGH 1
PS RHEUMATOID ARTHRITIS DRUG HYPERSENSITIVITY 1
PS RHEUMATOID ARTHRITIS DRUG INEFFECTIVE 1
PS RHEUMATOID ARTHRITIS DYSPEPSIA 1
PS RHEUMATOID ARTHRITIS ECONOMIC PROBLEM 1
PS RHEUMATOID ARTHRITIS FATIGUE 1
PS RHEUMATOID ARTHRITIS GAIT DISTURBANCE 1
PS RHEUMATOID ARTHRITIS GASTROOESOPHAGEAL REFLUX DISEASE 1
PS RHEUMATOID ARTHRITIS HEADACHE 2
PS RHEUMATOID ARTHRITIS HEART RATE INCREASED 1
PS RHEUMATOID ARTHRITIS HYPERTENSION 1
PS RHEUMATOID ARTHRITIS INCORRECT DOSE ADMINISTERED 1
PS RHEUMATOID ARTHRITIS LYMPHADENOPATHY 1
PS RHEUMATOID ARTHRITIS MALAISE 1
PS RHEUMATOID ARTHRITIS MITRAL VALVE INCOMPETENCE 1
PS RHEUMATOID ARTHRITIS NAUSEA 1
PS RHEUMATOID ARTHRITIS NON-CARDIAC CHEST PAIN 1
PS RHEUMATOID ARTHRITIS OROPHARYNGEAL PAIN 1
PS RHEUMATOID ARTHRITIS PALPITATIONS 1
PS RHEUMATOID ARTHRITIS PRODUCT QUALITY ISSUE 1
PS RHEUMATOID ARTHRITIS RHEUMATOID ARTHRITIS 1
PS RHEUMATOID ARTHRITIS RHINORRHOEA 1
PS RHEUMATOID ARTHRITIS STRESS 1
PS RHEUMATOID ARTHRITIS SYNCOPE 1
PS RHEUMATOID ARTHRITIS VOMITING 1
PS TENDONITIS ABDOMINAL DISCOMFORT 1
PS TENDONITIS ARTHRALGIA 1
PS TENDONITIS DRUG INEFFECTIVE 1
SS ARTHRITIS CHEST DISCOMFORT 1
SS ARTHRITIS CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1
SS ARTHRITIS GASTROOESOPHAGEAL REFLUX DISEASE 1
SS ARTHRITIS INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
SS ARTHRITIS OFF LABEL USE 1
SS ARTHRITIS THERAPEUTIC RESPONSE UNEXPECTED 1
SS ARTHRITIS THROAT IRRITATION 1
SS ARTHRITIS WEIGHT INCREASED 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE CHEST DISCOMFORT 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE GASTROOESOPHAGEAL REFLUX DISEASE 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
SS CHRONIC OBSTRUCTIVE PULMONARY DISEASE THROAT IRRITATION 1
SS CONVULSION OFF LABEL USE 1
SS CONVULSION THERAPEUTIC RESPONSE UNEXPECTED 1
SS CONVULSION WEIGHT INCREASED 1
SS DEPRESSION INSOMNIA 1
SS GASTROOESOPHAGEAL REFLUX DISEASE CHEST DISCOMFORT 1
SS GASTROOESOPHAGEAL REFLUX DISEASE CHRONIC OBSTRUCTIVE PULMONARY DISEASE 1
SS GASTROOESOPHAGEAL REFLUX DISEASE GASTROOESOPHAGEAL REFLUX DISEASE 1
SS GASTROOESOPHAGEAL REFLUX DISEASE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
SS GASTROOESOPHAGEAL REFLUX DISEASE THROAT IRRITATION 1
SS MYALGIA INSOMNIA 1
SS OSTEOARTHRITIS BRADYCARDIA 3
SS OSTEOARTHRITIS DIVERTICULUM 1
SS OSTEOARTHRITIS DIVERTICULUM INTESTINAL HAEMORRHAGIC 2
SS OSTEOARTHRITIS DIZZINESS 3
SS OSTEOARTHRITIS VASCULAR RUPTURE 3
SS OSTEOARTHRITIS WRONG TECHNIQUE IN DRUG USAGE PROCESS 3
SS PAIN IN EXTREMITY INSOMNIA 1
C RHEUMATOID ARTHRITIS CONTUSION 1
C RHEUMATOID ARTHRITIS HAEMORRHAGE 1
C RHEUMATOID ARTHRITIS PALLOR 1
I FIBROMYALGIA ATRIAL FIBRILLATION 2
I FIBROMYALGIA BLOOD CREATININE INCREASED 2
I FIBROMYALGIA BLOOD POTASSIUM INCREASED 2
I FIBROMYALGIA DIAPHRAGMALGIA 2
I FIBROMYALGIA DRUG INTERACTION 2
I FIBROMYALGIA HEART RATE DECREASED 2
I FIBROMYALGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
I FIBROMYALGIA RENAL FAILURE ACUTE 2
I PAIN ATRIAL FIBRILLATION 2
I PAIN BLOOD CREATININE INCREASED 2
I PAIN BLOOD POTASSIUM INCREASED 2
I PAIN DIAPHRAGMALGIA 2
I PAIN DRUG INTERACTION 2
I PAIN HEART RATE DECREASED 2
I PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
I PAIN RENAL FAILURE ACUTE 2
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