Side Effects of Benicar (olmesartan medoxomil)

Benicar (olmesartan medoxomil) tablets, for oral use, is an angiotensin II receptor blocker (ARB) used to treat high blood pressure (hypertension), alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks (myocardial infarctions).

Common side effects of Benicar include dizziness, chest pain, swelling of extremities, spinning sensation (vertigo), abdominal pain, indigestion, stomach upset, nausea, fast heart rate, high cholesterol, hyperlipemia, hyperuricemia. Joint pain, muscle pain, and rash.

Serious side effects of Benicar include changes in kidney function.

Drug interactions of Benicar include nonsteroidal anti-inflammatory drugs (NSAIDs) including selective COX-2 inhibitors because it may result in kidney problems, including kidney failure.

When pregnancy is detected, discontinue Benicar as soon as possible. It may cause birth defects or fetal death. It is unknown if Benicar passes into breast milk. Because of the potential for adverse effects on the nursing infant, breastfeeding is not recommended while using Benicar.

WARNING

FETAL TOXICITY

When pregnancy is detected, discontinue Benicar as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

What are the common side effects of Benicar?

Common side effects of Benicar include:

• dizziness,
• lightheadedness,
• bronchitis,
• back pain,
• joint or muscle pain,
• stomach pain,
• nausea,
• diarrhea,
• itching or skin rash,
• weakness,
• headache,
• flu-like symptoms,
• blood in the urine, and
• sinus infections.

What are the serious side effects of Benicar?

Potentially serious side effects of Benicar include:

• difficulty with breathing or swallowing,
• chest pain,
• cough,
• vertigo,
• abdominal pain,
• hyperkalemia,
• renal failure, and
• muscle tissue breakdown (rhabdomyolysis).

Agents Increasing Serum Potassium

• Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium. If co-medication is considered necessary, monitoring of serum potassium is advisable.

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

• 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.

Dual Blockade Of The Renin-Angiotensin System (RAS)

• 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 and other agents that affect the RAS.
• Do not co-administer aliskiren with Benicar in patients with diabetes. Avoid use of aliskiren with Benicar in patients with renal impairment (GFR <60 ml/min).

Lithium

• Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Benicar. Monitor serum lithium levels during concomitant use.

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.

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
• 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.