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 Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Hypertension: Most common adverse events (incidence greater than or equal to 5%) are cough, dizziness and back pain.
(6.1) Stable Coronary Artery Disease: Most common adverse events leading to discontinuation were cough, drug intolerance, and hypotension.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.
at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience The following adverse reactions are discussed elsewhere in labeling: Anaphylactoid reactions, including angioedema [see Warnings and Precautions (5.1) ] Hypotension [see Warnings and Precautions (5.2) ] Neutropenia and agranulocytosis [see Warnings and Precautions (5.3) ] Impaired renal function [see Warnings and Precautions (5.5) ] Hyperkalemia [see Warnings and Precautions (5.6) ] Cough [see Warnings and Precautions (5.7) ] Hypertension Perindopril erbumine has been evaluated for safety in approximately 3,400 patients with hypertension in U.S.
and foreign clinical trials.
The data presented here are based on results from the 1,417 perindopril erbumine-treated patients who participated in the U.S.
clinical trials.
Over 220 of these patients were treated with perindopril erbumine for at least one year.
5 WARNINGS AND PRECAUTIONS Watch for anaphylactoid reactions, including angioedema.
(5.1) Monitor renal function during therapy.
(5.5) Assess for hypotension and hyperkalemia.
(5.2 , 5.6) 5.1 Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including perindopril erbumine) may be subject to a variety of adverse events, some of them serious.
Black patients receiving ACE inhibitors have a higher incidence of angioedema compared to nonblacks.
Like all medications, Perindopril Erbumine 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: