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Benicar (Olmesartan Medoxomil) - Side Effects and Adverse Reactions



Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adult Hypertension
Benicar has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 for at least 1 year. Treatment with Benicar was well tolerated, with an incidence of adverse reactions similar to placebo. Events generally were mild, transient and had no relationship to the dose of Benicar.

The overall frequency of adverse reactions was not dose-related. Analysis of gender, age and race groups demonstrated no differences between Benicar and placebo-treated patients. The rate of withdrawals due to adverse reactions in all trials of hypertensive patients was 2.4% (i.e., 79/3278) of patients treated with Benicar and 2.7% (i.e., 32/1179) of control patients. In placebo-controlled trials, the only adverse reaction that occurred in more than 1% of patients treated with Benicar and at a higher incidence versus placebo was dizziness (3% vs. 1%).

The following adverse reactions occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with Benicar, but also occurred at about the same or greater incidence in patients receiving placebo: back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis and sinusitis.

The incidence of cough was similar in placebo (0.7%) and Benicar (0.9%) patients.

Other potentially important adverse reactions that have been reported with an incidence of greater than 0.5%, whether or not attributed to treatment, in the more than 3100 hypertensive patients treated with Benicar monotherapy in controlled or open-label trials are listed below.
Body as a Whole: chest pain, peripheral edema
Central and Peripheral Nervous System: vertigo
Gastrointestinal: abdominal pain, dyspepsia, gastroenteritis, nausea
Heart Rate and Rhythm Disorders: tachycardia
Metabolic and Nutritional Disorders: hypercholesterolemia, hyperlipemia, hyperuricemia
Musculoskeletal: arthralgia, arthritis, myalgia
Skin and Appendages: rash

Facial edema was reported in five patients receiving Benicar. Angioedema has been reported with angiotensin II antagonists.

Laboratory Test Findings: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Benicar.
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g/dL and 0.3 volume percent, respectively) were observed.

Liver Function Tests: Elevations of liver enzymes and/or serum bilirubin were observed infrequently. Five patients (0.1%) assigned to Benicar and one patient (0.2%) assigned to placebo in clinical trials were withdrawn because of abnormal liver chemistries (transaminases or total bilirubin). Of the five Benicar patients, three had elevated transaminases, which were attributed to alcohol use, and one had a single elevated bilirubin value, which normalized while treatment continued.

Pediatric Hypertension
No relevant differences were identified between the adverse experience profile for pediatric patients aged 1 to16 years and that previously reported for adult patients.

Post-Marketing Experience

The following adverse reactions have been reported in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: Asthenia, angioedema, anaphylactic reactions
Gastrointestinal: Vomiting, sprue-like enteropathy [see Warnings and Precautions ]
Metabolic and Nutritional Disorders: Hyperkalemia
Musculoskeletal: Rhabdomyolysis
Urogenital System: Acute renal failure, increased blood creatinine levels
Skin and Appendages: Alopecia, pruritus, urticaria

Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive. The randomized, placebo-controlled, double-blind ROADMAP trial (Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention trial, n=4447) examined the use of olmesartan, 40 mg daily, vs. placebo in patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional risk factor for CV disease. The trial met its primary endpoint, delayed onset of microalbuminuria, but olmesartan had no beneficial effect on decline in glomerular filtration rate (GFR). There was a finding of increased CV mortality (adjudicated sudden cardiac death, fatal myocardial infarction, fatal stroke, revascularization death) in the olmesartan group compared to the placebo group (15 olmesartan vs. 3 placebo, HR 4.9, 95% confidence interval [CI], 1.4, 17), but the risk of non-fatal myocardial infarction was lower with olmesartan (HR 0.64, 95% CI 0.35, 1.18).

The epidemiologic study included patients 65 years and older with overall exposure of > 300,000 patient-years. In the sub-group of diabetic patients receiving high-dose olmesartan (40 mg/d) for > 6 months, there appeared to be an increased risk of death (HR 2.0, 95% CI 1.1, 3.8) compared to similar patients taking other angiotensin receptor blockers. In contrast, high-dose olmesartan use in non-diabetic patients appeared to be associated with a decreased risk of death (HR 0.46, 95% CI 0.24, 0.86) compared to similar patients taking other angiotensin receptor blockers. No differences were observed between the groups receiving lower doses of olmesartan compared to other angiotensin blockers or those receiving therapy for < 6 months.

Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics.


Below is a sample of reports where side effects / adverse reactions may be related to Benicar. The information is not vetted and should not be considered as verified clinical evidence.

Possible Benicar side effects / adverse reactions in 64 year old male

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 64 year old male weighing 71.7 kg (157.7 pounds)

Reactions: Weight Decreased, Coeliac Disease, Hypotension

Suspect drug(s):
Benicar HCT
    Dosage: 40/12.5mg (qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01
    End date: 2010-01-01

    Dosage: 40 mg (40 mg, qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01

Other drugs received by patient: Pravastatin; Diovan; Aspirin

Possible Benicar side effects / adverse reactions in female

Reported by a consumer/non-health professional from Brazil on 2011-10-06

Patient: female

Reactions: Drug Ineffective, Hypothyroidism, Depression, Arteriosclerosis

Suspect drug(s):
    Dosage: 20 mg, per oral
    Administration route: Oral
    Indication: Arteriosclerosis
    Start date: 2006-01-01

    Dosage: 20 mg ( 20 mg, 1 in 1 d) , per oral
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-09-01

Other drugs received by patient: Hydrochlorothiazide/amiloride(hydrochlorothiasize, Amiloride) (Hydroch; Amiodarone HCL; Clonazepam

Possible Benicar side effects / adverse reactions in 80 year old male

Reported by a individual with unspecified qualification from Brazil on 2011-10-11

Patient: 80 year old male

Reactions: Overdose, Drug Administration Error, Gastrointestinal Carcinoma, Blood Pressure Abnormal, Headache

Suspect drug(s):
    Dosage: 120/15 mg (1 d), per oral : 160/20 mg (1 d), per oral : 40/5 mg (1 in 1 d), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-01
    End date: 2011-01-01

    Dosage: 120/15 mg (1 d), per oral : 160/20 mg (1 d), per oral : 40/5 mg (1 in 1 d), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01
    End date: 2011-08-01

    Dosage: 120/15 mg (1 d), per oral : 160/20 mg (1 d), per oral : 40/5 mg (1 in 1 d), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01

    Dosage: (2 in 1 m)
    Indication: Gastrointestinal Carcinoma
    Start date: 2011-07-01

Other drugs received by patient: Trimetazidine; Diltiazem HCL; Atorvastatin

See index of all Benicar side effect reports >>

Drug label data at the top of this Page last updated: 2014-09-25

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