Drug Safety Information for BENICAR (Olmesartan medoxomil)

Safety-related Labeling Changes for BENICAR (OLMESARTAN MEDOXOMIL) Rx Drug: FDA Link

Adverse Drug Reactions for BENICAR* (Olmesartan medoxomil)

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 BENICAR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea1172
2Diarrhoea1134
3Dizziness*1115
4Drug ineffective1071
5Fatigue*855
6Headache847
7Dyspnoea*844
8Vomiting740
9Blood pressure increased650
10Pain*647
11Hypertension646
12Hypotension643
13Asthenia642
14Weight decreased625
15Malaise608
16Fall592
17Pruritus588
18Renal failure acute562
19Oedema peripheral519
20Flushing519

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

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

Reason # of FDA Reports
1Hypertension*26189
2Product used for unknown indication9297
3Blood pressure*2087
4Essential hypertension*827
5Blood pressure abnormal538
6Blood pressure increased*348
7Cardiac disorder232
8Blood pressure management111
9Blood cholesterol increased105
10Diabetes mellitus84

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


Types of Adverse Events for BENICAR

Total Reports Filed with FDA: 84674


Number of FDA Adverse Event Reports by Patient Age for BENICAR

Total Reports Filed with FDA: 84674*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Olmesartan medoxomil (Azor 5/40, Olmetec, Votum, Benicar)

Charts are based on 84674 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 BENICAR Reviews and Review Summary .

Historical 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.