Icatibant: adverse event reports filed with FDA

1,945

reports as suspect product

0% of all reports · about 137 a year

143

reports, 12 months to June 2026

196 in the 12 months before

87.3%

marked serious by the reporter

75.3% across the class

5.9%

record death among outcomes, as reported

114 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 Icatibant reports recording the termmedian drug in bradykinin b2 receptor antagonist

1. Hereditary angioedema33.5%651
2. Weight increasedweight gain11.8%229
3. Weight decreasedweight loss11%213
4. Drug ineffectivethe medicine did not work as expected9.9%193
5. Product use issuea problem in how the product was used9.5%184
6. Malaisegeneral feeling of being unwell8.8%172
7. Headachehead pain8.3%162
8. Product dose omission issuea dose was missed7.8%152
9. Inappropriate schedule of product administrationthe product was taken at the wrong times7.4%143
10. Covid-19COVID-19 infection7.1%138
11. Stressstress6.9%135
12. Painpain, site not specified6.7%131
13. Product availability issuethe product was not available6.4%125
14. Injection site painpain where the injection was given6.3%123
15. Nauseafeeling sick5.8%112
16. Off label useused for a purpose or in a way not on the label5.7%111
17. Influenzaflu5.7%110
18. Falla fall5.4%105
19. Vomitingbeing sick5.2%102
20. Diarrhoealoose or frequent stools5.1%99
21. Fatiguetiredness4.9%96
22. Angioedemadeep swelling of skin or mucous membranes4.8%93
23. Treatment noncompliancethe treatment was not taken as directed4.8%93
24. Dizzinesslight-headedness or unsteadiness4.7%92
25. Abdominal painstomach or belly pain4.7%91
26. Dyspnoeashortness of breath4.4%85
27. Insurance issue4.1%79
28. Anxietyanxiety4%78
29. Astheniaweakness or lack of energy3.9%75
30. Product prescribing error3.8%73

Top 30 of 647 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 3 drugs in the bradykinin b2 receptor antagonist 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 5,620 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. 41.5% 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 1,945 reports.

Drugs most often listed in the same reports

Other products listed in reports where Icatibant 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 bradykinin b2 receptor antagonist 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 Icatibant as a suspect or interacting product; reports listing it only as a concomitant medication (857) 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.