Multaq: adverse event reports filed with FDA

5,773

reports as suspect product

0% of all reports · about 341 a year

289

reports, 12 months to June 2026

226 in the 12 months before

70.9%

marked serious by the reporter

73.5% across the class

4.7%

record death among outcomes, as reported

271 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 Multaq reports recording the termmedian drug in antiarrhythmic

1. Atrial fibrillationan irregular heart rhythm17.9%1,033
2. Dyspnoeashortness of breath9.8%566
3. Off label useused for a purpose or in a way not on the label7.1%411
4. Fatiguetiredness6.7%387
5. Nauseafeeling sick5.5%320
6. Diarrhoealoose or frequent stools5.1%293
7. Dizzinesslight-headedness or unsteadiness5%286
8. Blood creatinine increasedraised creatinine, a kidney test4.6%263
9. Astheniaweakness or lack of energy4.3%249
10. Drug interactionan interaction between medicines4.3%248
11. Drug ineffectivethe medicine did not work as expected3.5%203
12. Cardiac failureheart failure3.3%190
13. Oedema peripheralswelling of the legs, ankles or hands2.6%149
14. Palpitationsawareness of the heartbeat2.5%147
15. Condition aggravatedthe condition being treated got worse2.5%142
16. International normalised ratio increasedblood clotting slower than intended (raised INR)2.4%140
17. Cardiac failure congestivecongestive heart failure2.4%138
18. Malaisegeneral feeling of being unwell2.4%138
19. Weight increasedweight gain2.4%136
20. Coughcough2.2%127
21. Headachehead pain2.2%125
22. Heart rate increaseda fast heart rate reading2.1%121
23. Arrhythmia2.1%120
24. Heart rate decreased2.1%119
25. Renal failurekidney failure1.9%112
26. Bradycardiaslow heart rate1.9%111
27. Rashskin rash1.9%109
28. Vomitingbeing sick1.8%105
29. Feeling abnormalfeeling odd or not right1.8%104
30. Pruritusitching1.8%103

Top 30 of 695 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. 72.7% 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 5,773 reports.

Drugs most often listed in the same reports

Other products listed in reports where Multaq 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 Multaq as a suspect or interacting product; reports listing it only as a concomitant medication (3,353) 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.