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Tribenzor

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Tribenzor

Tribenzor

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 any other serious side effects, such as:

  • eye pain, vision problems;
  • feeling like you might pass out;
  • swelling in your hands, ankles, or feet;
  • urinating less than usual or not at all;
  • 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.

Less serious 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) »

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

SIDE EFFECTS: Dizziness, lightheadedness, tiredness, or headache may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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.

The hydrochlorothiazide in this product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, fast/irregular heartbeat, nausea/vomiting, severe dizziness, confusion, fainting, seizures.

Tell your doctor immediately if any of these unlikely but serious side effects occur: toe/joint pain, swelling hands/ankles/feet.

Tell your doctor immediately if any of these rare but serious side effect occurs: 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.

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
(Adverse Reactions)

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 (1.8) 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]

Musculoskeletal: rhabdomyolysis Urogenital System: acute renal failure

Skin and Appendages: alopecia, pruritus, urticaria

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.

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

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Tribenzor - User Reviews

Tribenzor User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Tribenzor sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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