Benicar HCT Side Effects

Please note - some side effects for Benicar HCT 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 HCT - for the consumer

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.

For the professional

Benicar HCT

Olmesartan medoxomil-hydrochlorothiazide has been evaluated for safety in 1243 hypertensive patients. Treatment with olmesartan medoxomil-hydrochlorothiazide 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-hydrochlorothiazide.

In the clinical trials, the overall frequency of adverse events was not dose-related. Analysis of gender, age and race groups demonstrated no differences between olmesartan medoxomil-hydrochlorothiazide and placebo-treated patients. The rate of withdrawals due to adverse events in all trials of hypertensive patients was 2.0% (25/1243) of patients treated with olmesartan medoxomil-hydrochlorothiazide and 2.0% (7/342) of patients treated with placebo.

In a placebo-controlled clinical trial, the following adverse events reported with olmesartan medoxomil-hydrochlorothiazide occurred in >2% of patients, and more often on the olmesartan medoxomil-hydrochlorothiazide combination than on placebo, regardless of drug relationship:

The following adverse events were also reported at a rate of >2%, but were as, or more, common in the placebo group: headache and urinary tract infection.

Other adverse events that have been reported with an incidence of greater than 1.0%, whether or not attributed to treatment, in the more than 1200 hypertensive patients treated with olmesartan medoxomil-hydrochlorothiazide in controlled or open-label trials are listed below.

     Body as a Whole:chest pain, back pain, peripheral edema
     Central and Peripheral Nervous System: vertigo
     Gastrointestinal: abdominal pain, dyspepsia, gastroenteritis, diarrhea
     Liver and Biliary System: SGOT increased, GGT increased, SGPT increased
     Metabolic and Nutritional: hyperlipemia, creatine phosphokinase increased, hyperglycemia
     Musculoskeletal: arthritis, arthralgia, myalgia
     Respiratory System: coughing
     Skin and Appendages Disorders: rash
     Urinary System: hematuria

Facial edema was reported in 2/1243 patients receiving olmesartan medoxomil-hydrochlorothiazide. Angioedema has been reported with angiotensin II receptor antagonists.

Other adverse events that have been reported with an incidence of greater than 0.5%, whether or not attributed to treatment, in more than 3100 hypertensive patients treated with olmesartan medoxomil monotherapy in controlled or open-label trials are tachycardia and hypercholesterolemia.

Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

     Body as a Whole:weakness
     Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation
     Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia
     Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions
     Metabolic: hyperglycemia, glycosuria, hyperuricemia
     Musculoskeletal: muscle spasm
     Nervous System/Psychiatric: restlessness
     Renal: renal failure, renal dysfunction, interstitial nephritis
     Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis
     Special Senses: transient blurred vision, xanthopsia

Laboratory Test Findings

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of olmesartan medoxomil-hydrochlorothiazide.

     Creatinine, Blood Urea Nitrogen:Increases in blood urea nitrogen (BUN) and serum creatinine of >50% were observed in 1.3% of patients. No patients were discontinued from clinical trials of olmesartan medoxomil-hydrochlorothiazide due to increased BUN or creatinine.

     Hemoglobin and Hematocrit:A greater than 20% decrease in hemoglobin and hematocrit was observed in 0.0 % and 0.4% (one patient), respectively, of olmesartan medoxomil-hydrochlorothiazide patients, compared with 0.0% and 0.0%, respectively, in placebo-treated patients. No patients were discontinued due to anemia.

     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

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