Amiodarone hydrochloride: adverse event reports filed with FDA

5,286

reports as suspect product

0% of all reports · about 236 a year

382

reports, 12 months to June 2026

542 in the 12 months before

92.7%

marked serious by the reporter

73.5% across the class

17.7%

record death among outcomes, as reported

933 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Amiodarone hydrochloride reports recording the termmedian drug in antiarrhythmic

1. Dyspnoeashortness of breath12.9%683
2. Off label useused for a purpose or in a way not on the label12.5%660
3. Astheniaweakness or lack of energy12.4%654
4. Product use in unapproved indicationused for a purpose not on the label11%584
5. Drug ineffectivethe medicine did not work as expected10.6%561
6. Fatiguetiredness9.8%516
7. Coughcough7.5%396
8. Drug interactionan interaction between medicines6.7%354
9. Pulmonary toxicity6.6%348
10. Nauseafeeling sick6.3%333
11. Hyperthyroidismoveractive thyroid6.3%331
12. Pulmonary fibrosis6%319
13. Condition aggravatedthe condition being treated got worse5.8%304
14. Dizzinesslight-headedness or unsteadiness5.7%302
15. General physical health deteriorationgeneral decline in health5.4%284
16. Vomitingbeing sick5.4%283
17. Blindnessloss of sight5.3%278
18. Hyponatraemialow blood sodium5.2%275
19. Pneumonialung infection5%262
20. Cardiogenic shockshock from the heart failing to pump4.9%260
21. Wheezingwheezing4.9%260
22. Multiple organ dysfunction syndromeseveral organs failing4.8%254
23. Gait disturbancedifficulty walking4.7%248
24. Abdominal painstomach or belly pain4.6%245
25. Hypotensionlow blood pressure4.5%239
26. Respiratory failurethe lungs could not supply enough oxygen4.5%239
27. Atrial fibrillationan irregular heart rhythm4.4%234
28. Sepsisa severe body-wide response to infection4.4%232
29. Unevaluable eventthe event could not be assessed4.3%226
30. Interstitial lung diseasescarring or inflammation of lung tissue4.2%223

Top 30 of 946 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 11 drugs in the antiarrhythmic class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 30,807 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 55.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 5,286 reports.

Drugs most often listed in the same reports

Other products listed in reports where Amiodarone hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the antiarrhythmic class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Amiodarone hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (3,762) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.