Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The safety profile of carvedilol phosphate extended-release capsules were similar to that observed for immediate-release carvedilol.
Most common adverse events seen with immediate-release carvedilol.
( 6.1 ): Heart failure and left ventricular dysfunction following myocardial infarction (greater than or equal to 10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase.
Hypertension (greater than or equal to 5%): Dizziness.
To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Carvedilol has been evaluated for safety in subjects with heart failure (mild, moderate, and severe), in subjects with left ventricular dysfunction following myocardial infarction, and in hypertensive subjects.
The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the subjects in the clinical trials.
Adverse events reported for each of these populations reflecting the use of either carvedilol phosphate extended-release capsules or immediate-release carvedilol are provided below.
Excluded are adverse events considered too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population.
5 WARNINGS AND PRECAUTIONS In clinical trials of extended-release carvedilol phosphate capsules in subjects with hypertension (338 subjects) and in subjects with left ventricular dysfunction following a myocardial infarction or heart failure (187 subjects), the profile of adverse events observed with carvedilol phosphate was generally similar to that observed with the administration of immediate-release carvedilol.
Therefore, the information included within this section is based on data from controlled clinical trials with extended-release carvedilol phosphate capsules as well as immediate-release carvedilol.
Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue.
( 5.1 ) Bradycardia, hypotension, worsening heart failure/fluid retention may occur.
Reduce the dose as needed.
Like all medications, Carvedilol Phosphate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: