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Tribenzor Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets is a combination of an angiotensin receptor blocker, calcium channel blocker, and diuretic used to treat high blood pressure. Common side effects of Tribenzor include dizziness, lightheadedness, tiredness, and headache.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Tribenzor in Detail - Patient Information: Side Effects
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:
- muscle spasms;
- cold symptoms such as stuffy nose, sneezing, sore throat; or
- flushing (warmth, redness, or tingly feeling).
Read the entire detailed patient monograph for Tribenzor (Olmesartan Medoxomil Amlodipine Hydrochlorothiazide Tablets) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Tribenzor Overview - Patient Information: Side Effects
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, confusion, decreased urination.
Tell your doctor right away if you have any serious side effects, including: 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), decrease in vision, eye pain, severe/persistent diarrhea.
Some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Tribenzor (Olmesartan Medoxomil Amlodipine Hydrochlorothiazide Tablets)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tribenzor FDA Prescribing 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.
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:
|Adverse Reaction||0M40/ AML10/ HCTZ25 mg
(N = 574)
|0M40/ AML10 mg
(N = 596)
(N = 580)
|AML10/ HCTZ25 mg
(N = 552)
|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 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 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
Psychiatric: sexual dysfunction (male* and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization
Autonomic Nervous System: dry mouth, sweating increased
Metabolic and Nutritional: hyperglycemia, thirst
* = 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.
Other adverse reactions that have been reported with hydrochlorothiazide, without regard to causality, are listed below:
Body as a Whole: weakness
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
Special Senses: transient blurred vision, xanthopsia
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.
The following adverse reactions have been reported in post-marketing experience:
Body as a Whole: asthenia, angioedema, anaphylactic reactions, peripheral edema
Urogenital System: acute renal failure
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.
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.
Read the entire FDA prescribing information for Tribenzor (Olmesartan Medoxomil Amlodipine Hydrochlorothiazide Tablets) »
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