Benicar Side Effects

Please note - some side effects for Benicar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Benicar - for the Consumer

Benicar

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Benicar:

Dizziness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; hoarseness); change in the amount of urine produced; chest pain; difficulty swallowing; fast, slow, or irregular heartbeat; muscle pain or cramps; symptoms of low blood pressure (eg, fainting, lightheadedness, severe dizziness).

Benicar HCT

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Benicar HCT:

Dizziness; nausea.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; decrease in sexual ability; decreased urination; depression; drowsiness; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hoarseness; muscle pain, tenderness, or cramps; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dry mouth; shortness of breath; swelling of the arms or legs; unusual bruising or bleeding; unusual thirst, tiredness, or weakness; vomiting; yellowing of the skin or eyes.

Benicar Side Effects - for the Professional

Benicar

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

Side Effects by Body System

Nervous system

Nervous system side effects have included dizziness (3% vs. 1% with placebo), vertigo (0.5% to 1% with placebo), and insomnia (0.5% to 1% with placebo). Asthenia has been reported in postmarketing experience.

Respiratory

Respiratory side effects have included cough (0.9% vs. 0.7% with placebo), bronchitis, rhinitis, pharyngitis, sinusitis, and upper respiratory tract infection.

Gastrointestinal

Gastrointestinal side effects including abdominal pain, dyspepsia, gastroenteritis, and nausea have been reported in 0.5% to 1% of patients. Vomiting has been reported in postmarketing experience. Diarrhea has been reported in more than 1% of patients but at the same or greater incidence than placebo.

Cardiovascular

Cardiovascular side effects including tachycardia, chest pain, and peripheral edema have been reported in 0.5% to 1% of patients. At least 5 cases of facial edema and at least one case of olmesartan-induced angioedema, which resolved over 7 to 10 days after discontinuing olmesartan, have been reported.

Metabolic

Metabolic side effects have included hyperglycemia and hypertriglyceridemia. Hyperkalemia has been reported in postmarketing experience.

Musculoskeletal

Musculoskeletal side effects including arthralgia, arthritis, myalgia, and skeletal pain have been reported in 0.5% to 1% of patients. Rhabdomyolysis have been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.

Dermatologic

Dermatologic side effects have included rash (0.5% to 1%), alopecia, pruritus, and urticaria.

Genitourinary

Genitourinary side effects including urinary tract infection have been reported in 0.5% to 1% of patients. Hematuria has been reported in more than 1% of patients but at the same or greater incidence than placebo.

Hematologic

Hematologic side effects have included decreased hemoglobin and hematocrit.

Hepatic

Hepatic side effects have rarely included liver enzyme and serum bilirubin elevations.

Other

Other side effects including back pain, increased creatine phosphokinase, headache, inflicted injury, influenza-like symptoms, and have been reported in more than 1% of patients but at the same or greater incidence than placebo. Fatigue and pain have been reported in 0.5% to 1% of patients.

Renal

Renal side effects associated with ACE inhibitors have included increases in serum creatinine or BUN in patients with renal artery stenosis. Acute renal failure and increased serum creatinine levels have been reported in postmarketing experience.

Hypersensitivity

Hypersensitivity side effects including rare cases of angioedema have been reported in patients receiving olmesartan.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.