CoAprovel Adverse Reactions

irbesartan + hydrochlorothiazide




Full Prescribing Info
Adverse Reactions
The frequency of adverse reactions listed as follows is defined using the following convention: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Irbesartan/Hydrocholorothiazide Combination: In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan/hydrochlorothiazide and the placebo groups. Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan/hydrochlorothiazide-treated patients than for placebo-treated patients. The incidence of adverse events was not related to gender, age, race, or dose within the recommended dose range. In placebo-controlled trials in which 898 hypertensive patients received various doses (range: irbesartan/hydrochlorothiazide 37.5/6.25 mg to 300/25 mg), the following adverse reactions were reported:
Nervous System Disorders: Common: Dizziness. Uncommon: Orthostatic dizziness.
Cardiac Disorders: Uncommon: Syncope, hypotension, tachycardia, edema.
Vascular Disorders: Uncommon: Flushing.
Gastrointestinal Disorders: Common: Nausea and vomiting. Uncommon: Diarrhea.
Musculoskeletal, Connective Tissue and Bone Disorders: Uncommon: Swelling extremity.
Renal and Urinary Disorders: Common: Abnormal urination.
Reproductive System and Breast Disorders: Uncommon: Sexual dysfunction, libido changes.
General Disorders and Administration Site Conditions: Common: Fatigue.
Investigations: Patients treated with irbesartan/hydrochlorothiazide had changes in laboratory test parameters which were rarely clinically significant. Common: Increases in blood urea nitrogen (BUN), creatinine and creatinine kinase. Uncommon: Decreases in serum potassium and sodium.
In addition, since introduction of irbesartan/hydrochlorothiazide in the market the following adverse reactions have also been reported:
Immune System Disorders: Rare: As with other angiotensin-II receptor antagonists, rare cases of hypersensitivity reactions eg, angioedema, rash, urticaria have been reported.
Metabolism and Nutrition Disorders: Very Rare: Hyperkalemia.
Nervous System Disorders: Very Rare: Headache.
Ear and Labyrinth Disorders: Very Rare: Tinnitus.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Cough.
Gastrointestinal Disorders: Very Rare: Dyspepsia, dysgeusia.
Hepatobiliary Disorders: Very Rare: Hepatitis, abnormal liver function.
Musculoskeletal, Connective Tissue and Bone Disorders: Very Rare: Arthralgia, myalgia.
Renal and Urinary Disorders: Very Rare: Impaired renal function including isolated cases of renal failure in patients at risk (see Precautions).
Additional Information on Individual Components: In addition to the mentioned adverse reactions for the combination product, other undesirable effects previously reported with one of the individual components may be potential undesirable effects with CoAprovel.
Irbesartan: General Disorders and Administration Site Conditions: Uncommon: Chest pain.
Hydrochlorothiazide: Adverse events (regardless of relationship to drug) reported with the use of hydrochlorothiazide alone include:
Blood and Lymphatic System: Aplastic anemia, bone marrow suppression, neutropenia/agranulocytosis, hemolytic anemia, leucopenia, thrombocytopenia.
Psychiatric Disorders: Depression, sleep disturbances.
Nervous System Disorders: Vertigo, paraesthesia, lightheadedness, restlessness.
Eye Disorders: Transient blurred vision, xanthopsia.
Cardiac Disorders: Cardiac arrhythmias.
Vascular Disorders: Postural hypotension.
Respiratory, Thoracic and Mediastinal Disorders: Respiratory distress (including pneumonitis and pulmonary edema).
Gastrointestinal Disorders: Pancreatitis, anorexia, diarrhea, constipation, gastric irritation, sialadenitis, loss of appetite.
Hepatobiliary Disorders: Jaundice (intrahepatic cholestatic jaundice).
Skin and Subcutaneous Tissue Disorders: Anaphylactic reactions, toxic epidermal necrolysis, necrotizing angiitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria.
Musculoskeletal, Connective Tissue and Bone Disorders: Weakness and muscle spasm.
Renal and Urinary Disorders: Interstitial nephritis and renal dysfunction.
General Disorders and Administration Site Conditions: Fever.
Investigations: Electrolyte imbalance (including hypokalemia and hyponatremia, see also Precautions), hyperuricemia, glycosuria, hyperglycemia, increases in cholesterol and triglycerides.
The dose-dependent side effects of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
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