Drug Safety Information for VIMOVO (Esomeprazole magnesium; naproxen)

Safety-related Labeling Changes for VIMOVO (ESOMEPRAZOLE MAGNESIUM; NAPROXEN) Rx Drug: FDA Link

Adverse Drug Reactions for VIMOVO* (Esomeprazole magnesium; naproxen)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with VIMOVO
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain98
2Drug dose omission80
3Drug ineffective73
4Arthralgia63
5Off label use63
6Dyspnoea49
7Nausea47
8Pain in extremity46
9Diarrhoea46
10Dizziness44
11Arthritis43
12Malaise43
13Abdominal discomfort40
14Headache39
15Fall38
16Gastrointestinal haemorrhage34
17Abdominal pain upper34
18Fatigue31
19Dyspepsia29
20Rash29

* This side effect also appears in "Top 10 Side Effects of VIMOVO " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking VIMOVO
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication286
2Pain256
3Osteoarthritis235
4Rheumatoid arthritis206
5Arthritis175
6Arthralgia116
7Inflammation102
8Back pain94
9Gastrooesophageal reflux disease64
10Analgesic therapy35

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for VIMOVO

Total Reports Filed with FDA: 3786


Number of FDA Adverse Event Reports by Patient Age for VIMOVO

Total Reports Filed with FDA: 3786*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Esomeprazole magnesium; naproxen (Vimovo)

Charts are based on 3786 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and VIMOVO Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on VIMOVO's side effects.