Dilatrend Adverse Reactions

Clinical Trials: Adverse Drug Reactions (ADRs) are listed according to MedDRA system organ class and CIOMS frequency category: Very common ≥ 1/10; Common ≥ 1/100 and < 1/10; Uncommon ≥ 1/1,000 and < 1/100; Rare ≥ 1/10,000 and < 1/1,000; Very rare < 1/10,000.
The table below summarizes undesirable effects that have been reported in association with the use of carvedilol in pivotal clinical trials with following indications: chronic heart failure, left ventricular dysfunction following acute myocardial infarction, hypertension and the long term management of coronary heart disease. (see Table.)

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Description of Selected Adverse Reactions: The frequency of adverse reactions is not dose-dependent, with the exception of dizziness, abnormal vision and bradycardia. Dizziness, syncope, headache and asthenia are usually mild and are more likely to occur at the beginning of treatment.
In patients with congestive heart failure, worsening cardiac failure and fluid retention may occur during up-titration of carvedilol dose (see Precautions).
Cardiac failure was a very commonly reported adverse event in both placebo (14.5%) and carvedilol-treated (15.4%) patients, in patients with left ventricular dysfunction following acute myocardial infarction.
Reversible deterioration of renal function has been observed with carvedilol therapy in chronic heart failure patients with low blood pressure, ischaemic heart disease and diffuse vascular disease and/ or underlying renal insufficiency (see Precautions).
Post Marketing: The following adverse events have been identified during post-marketing use of carvedilol. Because these events are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency and/or establish a causal relationship to drug exposure.
Metabolism and Nutrition Disorders: Due to the β-blocking properties, it is also possible for latent diabetes mellitus to become manifest, manifest diabetes to be aggravated, and blood glucose counter-regulation to be inhibited.
Skin and Subcutaneous Tissue Disorders: Alopecia: Severe cutaneous adverse reactions (Toxic epidermal necrolysis, Stevens-Johnson syndrome (see Precautions)).
Renal and Urinary Disorders: Isolated cases of urinary incontinence in women, which resolved upon discontinuation of the medication, have been reported.