Tribenzor Side Effects

Generic Name: amlodipine / hydrochlorothiazide / olmesartan

Note: This page contains side effects data for the generic drug amlodipine / hydrochlorothiazide / olmesartan. It is possible that some of the dosage forms included below may not apply to the brand name Tribenzor.

It is possible that some side effects of Tribenzor may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to amlodipine / hydrochlorothiazide / olmesartan: oral tablet

As well as its needed effects, amlodipine / hydrochlorothiazide / olmesartan may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking amlodipine / hydrochlorothiazide / olmesartan, check with your doctor immediately:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss
Less common
  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • fainting
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • swelling of the joints
  • unusual tiredness or weakness

Some amlodipine / hydrochlorothiazide / olmesartan side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Diarrhea
  • muscle aches or spasms
  • nausea

For Healthcare Professionals

Applies to amlodipine / hydrochlorothiazide / olmesartan: oral tablet

Nervous system

Nervous system side effects associated with amlodipine / hydrochlorothiazide / olmesartan in combination have included dizziness (1.4 to 3.6%) headache (6.4%), fatigue (4.2%), and syncope (1%).

Nervous system side effects associated with amlodipine have included headache (8%), dizziness (3%), and fatigue (5%). Vertigo, tremors, and paresthesias have been reported in less than 1% of patients receiving amlodipine.

Nervous system side effects associated with hydrochlorothiazide have included cerebrovascular insufficiency associated with HCTZ-induced plasma volume contraction. At least one case of cognitive and neurologic impairment (i.e., confusion, somnolence, feeling dazed) has been reported. Symptoms immediately resolved following discontinuation of hydrochlorothiazide.

Nervous system side effects associated with olmesartan 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.[Ref]

Cardiovascular

Cardiovascular side effects associated with amlodipine are dose-related, are usually the result of vasodilation, and include flushing in less than 1% and peripheral edema in 2% of patients. Peripheral edema may become a chronic problem, and has occurred in up to 10% of patients who are receiving 10 mg doses. Palpitations occur in 1% to 5% of patients. Recent data have shown that the use of amlodipine in patients with NYHA Class III or IV heart failure is not associated with worsened heart failure. Bradycardia, hypotension, and syncope have been reported in less than 1% of patients. Generalized edema has also been reported rarely.

Cardiac arrhythmias, including ventricular ectopy and complete AV heart block, are associated with hypokalemia and hyponatremia due to HCTZ. Hypotension has been reported in association with HCTZ-induced pulmonary edema. Orthostatic hypotension may occur and may rarely be associated with syncope, particularly in the elderly.

Cardiovascular side effects associated with olmesartan 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.[Ref]

Dermatologic

Dermatologic side effects including amlodipine-associated lichen planus and telangiectasia have been rarely reported.

Dermatologic side effects associated with HCTZ include case reports of erythema annular centrifugum, acute eczematous dermatitis, and morbilliform and leukocytoclastic vasculitis. Thiazides may induce phototoxic dermatitis. In addition, a rare, distinct entity with clinical and laboratory features indistinguishable from those of subacute cutaneous lupus erythematosus is associated with HCTZ.

Dermatologic side effects associated with olmesartan have included rash (0.5% to 1%), alopecia, pruritus, and urticaria.[Ref]

Endocrine

Endocrine side effects including a single case of gynecomastia have been associated with the use of amlodipine.

Endocrine side effects associated with thiazide diuretics include a single case of recurrent parathyroid adenoma, although the association is probably coincidental.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea have been associated with amlodipine in 3% of patients.

Gastrointestinal side effects are associated with hydrochlorothiazide are unusual, and include case reports of pancreatitis, nausea, and acute cholecystitis.

Gastrointestinal side effects including abdominal pain, dyspepsia, gastroenteritis, and nausea have been reported in 0.5% to 1% of patients receiving olmesartan. 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.[Ref]

Genitourinary

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

Hematologic

Hematologic side effects associated with amlodipine have included isolated cases of thrombocytopenia.

Hematologic side effects associated with hydrochlorothiazide are rare. Cases of immune-complex hemolytic anemia, aplastic anemia, and thrombocytopenia have been reported.

Hematologic side effects associated with olmesartan have included decreased hemoglobin and hematocrit.[Ref]

Hypersensitivity

Hypersensitivity reactions have rarely been reported, although experience with amlodipine is limited. A single case of erythema multiforme during amlodipine therapy has been reported.

Hypersensitivity (usually nausea, vomiting, diarrhea, and rash) has been reported in less than 1% of patients taking hydrochlorothiazide. Rare cases of acute pulmonary edema, interstitial cystitis, and interstitial nephritis, and anaphylaxis have been reported.

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

Metabolic

Metabolic side effects associated with hydrochlorothiazide are common, especially when doses greater than 50 mg per day are used. Mild hypokalemia (decrease of 0.5 mEq/L) occurs in up to 50% of patients, and may predispose patients to cardiac arrhythmias. Metabolic alkalosis, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, and elevated serum uric acid levels are also relatively common. Metabolic problems associated with thiazide diuretics also include glucose intolerance and a potentially deleterious effect on the lipid profile (i.e., increased serum cholesterol).

Metabolic side effects associated with olmesartan have included hyperglycemia and hypertriglyceridemia.[Ref]

Musculoskeletal

Musculoskeletal side effects associated with hydrochlorothiazide are unusual, and include case reports of myalgias and chills. Preservation of mineral bone density has also been observed in older patients.

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

Other

Other side effects including a single case of acute porphyria exacerbation have been associated with the use of amlodipine, and confirmed upon rechallenge in the same patient. Peripheral edema and anaphylactic reactions have been reported postmarketing.[Ref]

Renal

Renal side effects have been reported rarely with amlodipine use. At least one case of interstitial nephritis has been associated with amlodipine therapy.

Renal insufficiency, manifest as an increase in serum creatinine and BUN may occur due to HCTZ-induced intravascular volume depletion. Rare cases of interstitial nephritis have been reported.

Renal side effects associated with ACE inhibitors like olmesartan 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.[Ref]

Respiratory

Respiratory side effects associated with hydrochlorothiazide are rare, and include approximately 40 case reports of acute noncardiogenic pulmonary edema. These cases are thought to be due to idiosyncrasy or a hypersensitivity mechanism.

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

Ocular

Ocular side effects have included idiosyncratic reactions to the hydrochlorothiazide component resulting in acute transient myopia and acute angle-closure glaucoma.

References

1. "Product Information. Tribenzor (amlodipine / hydrochlorothiazide / olmesartan)." Daiichi Pharmaceuticals, Montvale, NJ.

2. "Product Information. Benicar (olmesartan)." Sankyo Parke Davis, Parsippany, NJ.

3. "Product Information. Norvasc (amlodipine)." Pfizer US Pharmaceuticals, New York, NY.

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