Drugs
Amiodarone hydrochloride (marketed as Cordarone) Information
FDA ALERT [05/2005] – Pulmonary toxicity, Hepatic Injury, and Worsened Arrhythmia
Amiodarone may cause potentially fatal toxicities, including pulmonary toxicity, hepatic injury, and worsened arrhythmia.
Amiodarone should only be used to treat adults with life-threatening ventricular arrhythmias when other treatments are ineffective or have not been tolerated.
This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
Other Information
-
Amiodarone is marketed under this name:
-
Cordarone
-
Pacerone
-
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.
Related Information
Labeling and Regulatory History from Drugs@FDA
Contact Us
Report a Serious Problem
- 1-800-332-1088
- 1-800-FDA-0178 Fax
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787