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Benicar (Olmesartan Medoxomil) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 events similar to placebo. Events generally were mild, transient and had no relationship to the dose of olmesartan medoxomil.

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

The following adverse events occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with olmesartan medoxomil, 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 events 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 olmesartan medoxomil 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 5 patients receiving olmesartan medoxomil. 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 olmesartan medoxomil.

     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 olmesartan medoxomil 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 olmesartan medoxomil patients, three had elevated transaminases, which were attributed to alcohol use, and one had a single elevated bilirubin value, which normalized while treatment continued.

Post-Marketing Experience: The following adverse reactions have been reported in post-marketing experience:

     Body as a Whole: Asthenia, angioedema
     Gastrointestinal: Vomiting
     Metabolic and Nutritional Disorders: Hyperkalemia
     Musculoskeletal: Rhabdomyolysis
     Urogenital System: Acute renal failure, increased blood creatinine levels
     Skin and Appendages: Alopecia, pruritus, urticaria



REPORTS OF SUSPECTED BENICAR SIDE EFFECTS / ADVERSE REACTIONS

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

Benicar
    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):
Simvastatin
    Dosage: 20 mg, per oral
    Administration route: Oral
    Indication: Arteriosclerosis
    Start date: 2006-01-01

Benicar
    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):
Benicar
    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

Benicar
    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

Benicar
    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

Chemotherapy
    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: 2008-06-24

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