Benicar HCT

Last updated on RxList: 1/11/2021
Benicar HCT Side Effects Center

What Is Benicar HCT?

Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist and a thiazide diuretic (water pill) used to treat high blood pressure (hypertension).

What Are Side Effects of Benicar HCT?

Common side effects of Benicar HCT include dizziness or lightheadedness as your body adjusts to the medication. Other side effects of Benicar HCT include:

Tell your doctor if you have serious side effects of Benicar HCT including:

  • fainting,
  • decrease in vision,
  • eye pain,
  • symptoms of a high potassium blood level (such as muscle weakness, slow or irregular heartbeat),
  • unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), or
  • severe or persistent diarrhea.

Dosage for Benicar HCT

The usual recommended starting dose of Benicar is 20 mg once daily. For patients requiring further reduction in blood pressure after 2 weeks, dose may be increased to 40 mg.

What Drugs, Substances, or Supplements Interact with Benicar HCT?

Benicar HCT may interact with:

  • other blood pressure medications,
  • steroids,
  • lithium,
  • cholestyramine or colestipol,
  • insulin or oral diabetes medicine,
  • barbiturates,
  • other diuretics,
  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs),
  • muscle relaxers, or
  • narcotics

Tell your doctor all medications you use.

Benicar HCT and Pregnancy

Benicar HCT is not recommended for use during pregnancy due to the risk for harm to a fetus. It is unknown if olmesartan passes into breast milk. Hydrochlorothiazide passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

How to Lower Blood Pressure: Exercise Tips See Slideshow
Benicar HCT Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, this medicine can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Also call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • eye pain, vision problems;
  • an unusual skin rash;
  • easy bruising, unusual bleeding;
  • jaundice (yellowing of the skin or eyes);
  • kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
  • low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
  • high potassium--slow or unusual heart rate, weakness, loss of movement; or
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects include:

  • nausea;
  • dizziness;
  • cold symptoms such as stuffy nose, sneezing, sore throat; or
  • high levels of uric acid in your blood.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Benicar HCT (Olmesartan Medoxomil-Hydrochlorothiazide)

QUESTION

Salt and sodium are the same. See Answer
Benicar HCT Professional Information

SIDE EFFECTS

The following adverse reactions with BENICAR HCT are described elsewhere:

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.

Olmesartan Medoxomil And Hydrochlorothiazide

The concomitant use of olmesartan medoxomil and hydrochlorothiazide was evaluated for safety in 1243 hypertensive patients. Treatment with olmesartan medoxomil and hydrochlorothiazide was well tolerated, with an incidence of adverse events similar to that of placebo. Adverse reactions were generally mild, transient and not dependent on the dose of olmesartan medoxomil and hydrochlorothiazide.

The rate of withdrawals for adverse events in all trials of hypertensive patients was 2.0% (25/1243) on olmesartan medoxomil plus hydrochlorothiazide and 2.0% (7/342) on placebo.

In a placebo-controlled, factorial clinical trial of olmesartan medoxomil (2.5 mg to 40 mg) and hydrochlorothiazide (12.5 mg to 25 mg), the following adverse reactions reported in Table 1 occurred in > 2% of patients, and more often on the olmesartan medoxomil and hydrochlorothiazide combination than on placebo.

Table 1: Adverse Reactions in a Factorial Trial of Patients with Hypertension

Olmesartan/ HCTZ
(N=247) (%)
Olmesartan
(N=125) (%)
HCTZ
(N=88) (%)
Placebo
(N=42) (%)
Nausea 3 2 1 0
Hyperuricemia 4 0 2 2
Dizziness 9 1 8 2
Upper Respiratory Infection 7 6 7 0

Other adverse reactions 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 and 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, ALT increased

Metabolic and Nutritional: creatine phosphokinase increased

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 and hydrochlorothiazide. Angioedema has been reported with angiotensin II receptor antagonists, including BENICAR HCT.

Hydrochlorothiazide

Other adverse reactions that have been reported with hydrochlorothiazide 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: glycosuria, hyperuricemia

Musculoskeletal: muscle spasm

Nervous System/Psychiatric: restlessness

Renal: renal dysfunction, interstitial nephritis

Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis

Special Senses: transient blurred vision, xanthopsia

Clinical Laboratory Test Findings

Creatinine/blood urea nitrogen (BUN): Minor elevations in creatinine and BUN occurred in 1.7% and 2.5% respectively, of patients taking BENICAR HCT and 0% and 0% respectively, given placebo in controlled clinical trials.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of BENICAR HCT. 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

Gastrointestinal: Vomiting

Metabolic: Hyperkalemia

Musculoskeletal: Rhabdomyolysis

Skin and Appendages: Alopecia, pruritus

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 highdose 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.

DRUG INTERACTIONS

Agents Increasing Serum Potassium

Coadministration of BENICAR HCT with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

Lithium

Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or hydrochlorothiazide. Monitor serum lithium levels during concomitant use.

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors )

Olmesartan Medoxomil

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including olmesartan medoxomil) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors.

Hydrochlorothiazide

In some patients the administration of a NSAID can reduce the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics. Therefore, monitor blood pressure closely.

Dual Blockade Of The Renin Angiotens In System

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on BENICAR HCT and other agents that affect the RAS.

Do not co-administer aliskiren with BENICAR HCT in patients with diabetes [see CONTRAINDICATIONS]. Avoid use of aliskiren with BENICAR HCT in patients with renal impairment (GFR < 60 ml/min).

Colesevelam Hydrochloride

Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose [see CLINICAL PHARMACOLOGY].

Use Of Hydrochlorothiazide With Other Drugs

When administered concurrently the following drugs may interact with thiazide diuretics:

Antidiabetic drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required.

Ion exchange resins: Staggering the dosage of hydrochlorothiazide and ion exchange resins (e.g., cholestyramine, colestipol) such that hydrochlorothiazide is administered at least 4 hours before or 4 – 6 hours after the administration of resins would potentially minimize the interaction [see CLINICAL PHARMACOLOGY].

Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia.

Read the entire FDA prescribing information for Benicar HCT (Olmesartan Medoxomil-Hydrochlorothiazide)

© Benicar HCT Patient Information is supplied by Cerner Multum, Inc. and Benicar HCT Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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