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Tribenzor

Last reviewed on RxList: 1/30/2017
Tribenzor Side Effects Center

Last reviewed on RxList 11/14/2016

Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets is a combination of an angiotensin receptor blocker, a calcium channel blocker, and a diuretic used to treat high blood pressure. Common side effects of Tribenzor include:

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

  • fainting,
  • severe tiredness,
  • big toe/joint pain,
  • swelling hands/ankles/feet,
  • symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat),
  • unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), and
  • severe or persistent diarrhea.

The recommended dosage of Tribenzor is once daily. Other medications that lower blood pressure, heart medication, other diuretics, potassium supplements, insulin, lithium, steroid medications, aspirin, and narcotic mediations may interact with Tribenzor. Tell your doctor all medications you take. Before taking Tribenzor tell your doctor if you have kidney or liver disease, congestive heart failure, chest pain, coronary artery disease, glaucoma, lupus, diabetes, or are allergic to penicillin. Do not take Tribenzor if you are pregnant or breastfeeding.

Our Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets 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.

Tribenzor Consumer Information

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

Call your doctor at once if you have:

  • eye pain, vision problems;
  • a light-headed feeling, like you might pass out;
  • swelling in your hands, ankles, or feet;
  • little or no urinating;
  • pain or burning when you urinate;
  • joint pain or swelling with fever, swollen glands, muscle aches, unusual thoughts or behavior, patchy skin color, red spots, or skin rash on your face;
  • headache, trouble concentrating, memory problems, weakness, feeling unsteady, hallucinations, fainting, seizure, shallow breathing;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
  • electrolyte imbalance--nausea, loss of appetite, uneven heart rate, extreme thirst, increased urination, leg discomfort, jerking muscle movements, muscle weakness or limp feeling, confusion, and feeling tired or restless.

Common side effects may include:

  • dizziness;
  • diarrhea;
  • muscle spasms;
  • cold symptoms such as stuffy nose, sneezing, sore throat; or
  • flushing (warmth, redness, or tingly feeling).

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 Tribenzor (Olmesartan Medoxomil Amlodipine Hydrochlorothiazide Tablets)

Tribenzor Professional Information

SIDE EFFECTS

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.

Tribenzor

In the controlled trial of Tribenzor, patients were randomized to Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide 40/10/25 mg), olmesartan medoxomil/amlodipine 40/10 mg, olmesartan medoxomil/hydrochlorothiazide 40/25 mg, or amlodipine/hydrochlorothiazide 10/25 mg. Subjects who received triple combination therapy were treated between two and four weeks with one of the three dual combination therapies. Safety data from this study were obtained in 574 patients with hypertension who received Tribenzor for 8 weeks.

The frequency of adverse reactions was similar between men and women, patients < 65 years of age and patients ≥ 65 years of age, patients with and without diabetes, and Black and non-Black patients. Discontinuations because of adverse events occurred in 4% of patients treated with Tribenzor 40/10/25 mg compared to 1% of patients treated with olmesartan medoxomil/amlodipine 40/10 mg, 2% of patients treated with olmesartan medoxomil/hydrochlorothiazide 40/25 mg, and 2% of patients treated with amlodipine/hydrochlorothiazide 10/25 mg. The most common reason for discontinuation with Tribenzor was dizziness (1%).

Dizziness was one of the most frequently reported adverse reactions with incidence of 1.4% to 3.6% in subjects continuing on dual combination therapy compared to 5.8% to 8.9% in subjects who switched to Tribenzor.

The other most frequent adverse reactions that occurred in at least 2% of subjects are presented in the table below:

Table 1

Adverse Reaction OM40/ AML10/ HCTZ25 mg
(N = 574) n (%)
OM40/ AML10 mg
(N = 596) n (%)
OM40/ HCTZ25mg
(N = 580) n (%)
AML10/ HCTZ25 mg
(N = 552) n (%)
Edema peripheral 44 (7.7) 42 (7.0) 6 (1.0) 46 (8.3)
Headache 37 (6.4) 42 (7.0) 38 (6.6) 33 (6.0)
Fatigue 24 (4.2) 34 (5.7) 31 (5.3) 36 (6.5)
Nasopharyngitis 20 (3.5) 11 (18) 20 (3.4) 16 (2.9)
Muscle spasms 18 (3.1) 12 (2.0) 14 (2.4) 13 (2.4)
Nausea 17 (3.0) 12 (2.0) 22 (3.8) 12 (2.2)
Upper respiratory tract infection 16 (2.8) 26 (4.4) 18 (3.1) 14 (2.5)
Diarrhea 15 (2.6) 14 (2.3) 12 (2.1) 9 (1.6)
Urinary tract infection 14 (2.4) 8 (1.3) 6 (1.0) 7 (1.3)
Joint swelling 12 (2.1) 17 (2.9) 2 (0.3) 16 (2.9)

Syncope was reported by 1% of Tribenzor subjects compared to 0.5% or less for the other treatment groups.

Olmesartan Medoxomil

Olmesartan medoxomil 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 treated for at least 1 year. Treatment with olmesartan medoxomil was well tolerated, with an incidence of adverse reactions similar to that seen with placebo. Adverse reactions were generally mild, transient, and without relationship to the dose of olmesartan medoxomil.

Amlodipine

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials.

The following adverse reactions occurred in < 1% but > 0.1% of patients in controlled clinical trials under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert physicians to a possible relationship:

Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis

Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo

Gastrointestinal: anorexia, constipation, dyspepsia*, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia

General: allergic reaction, asthenia*, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease

Musculoskeletal System: arthralgia, arthrosis, muscle cramps*, myalgia

Psychiatric: sexual dysfunction (male* and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization

Respiratory: dyspnea*, epistaxis

Skin and Appendages: angioedema, erythema multiforme, pruritus*, rash*, rash erythematous, rash maculopapular

Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus

Urinary System: micturition frequency, micturition disorder, nocturia

Autonomic Nervous System: dry mouth, sweating increased

Metabolic and Nutritional: hyperglycemia, thirst Hemopoietic: leukopenia, purpura, thrombocytopenia

* = events that occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.

The following adverse reactions occurred in < 0.1% of patients: cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, coughing, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia.

Hydrochlorothiazide

Other adverse reactions 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

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of the individual components of Tribenzor. 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.

Olmesartan Medoxomil

The following adverse reactions have been reported in post-marketing experience:

Body as a Whole: asthenia, angioedema, anaphylactic reactions, peripheral edema

Gastrointestinal: vomiting, diarrhea, sprue-like enteropathy [see WARNINGS AND PRECAUTIONS]

Metabolic and Nutritional Disorders: hyperkalemia

Musculoskeletal: rhabdomyolysis

Urogenital System: acute renal failure, increased blood creatinine

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. 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 high-dose 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.

Amlodipine

The following post-marketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In post-marketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine. Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine.

Read the entire FDA prescribing information for Tribenzor (Olmesartan Medoxomil Amlodipine Hydrochlorothiazide Tablets)

Related Resources for Tribenzor

Read the Tribenzor User Reviews »

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

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