Converium 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 (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000).
Hypertension: in placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%). Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3%) than for placebo-treated patients (4.5%). The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
In placebo-controlled trials in which 1,965 patients received irbesartan, the following adverse drug reactions were reported: Nervous system disorders: Common: dizziness; Not known: vertigo.
Cardiac disorders: Uncommon: tachycardia.
Vascular disorders: Uncommon: flushing.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough.
Gastrointestinal disorders: Common: nausea/vomiting; Uncommon: diarrhoea, dyspepsia/heartburn.
Reproductive system and breast disorders: Uncommon: sexual dysfunction.
General disorders and administration site conditions: Common: fatigue; Uncommon: chest pain.
Investigations: Common: significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects. None of these increases were associated with identifiable clinical musculoskeletal events.
Hypertension and type 2 diabetes with renal disease: in addition to the adverse drug reactions mentioned under hypertension, in diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i.e., uncommon) but in excess of placebo.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, the following additional adverse reactions were reported in >2% of patients and in excess of placebo: Nervous system disorders: Common: orthostatic dizziness.
Vascular disorders: Common: orthostatic hypotension.
Musculoskeletal, connective tissue and bone disorders: Common: musculoskeletal pain.
Investigations: Hyperkalaemia occurred more often in diabetic patients treated with irbesartan than with placebo. In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥5.5 mEq/L) occurred in 29.4% (i.e. very common) of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group. In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥5.5 mEq/L) occurred in 46.3% (i.e. very common) of the patients in the irbesartan group and 26.3% of the patients in the placebo group. A decrease in haemoglobin, which was not clinically significant, has been observed in 1.7% (i.e. common) of hypertensive patients with advanced diabetic renal disease treated with irbesartan.
In addition, since introduction of irbesartan in the market the following adverse drug reactions have also been reported: Immune system disorders: Rare: as with other angiotensin-II receptor antagonists, rare cases of hypersensitivity reactions such as rash, urticaria, angioedema have been reported.
Metabolism and nutrition disorders: Very rare: hyperkalaemia.
Nervous system disorders: Very rare: headache.
Ear and labyrinth disorders: Very rare: tinnitus.
Gastrointestinal disorders: Very rare: Dysgeusia.
Hepato-biliary disorders: Uncommon: jaundice; Very rare: hepatitis, abnormal liver function.
Musculoskeletal, connective tissue and bone disorders: Very rare: myalgia, arthralgia.
Renal and urinary disorders: Very rare: impaired renal function including isolated cases of renal failure in patients at risk (see Precautions).