What the label lists and what reports show
Icatibant side effects
Icatibant's FDA label: “The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials.” FAERS holds 8,823 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is weight decreased (641 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the icatibant FDA label on DailyMed (effective July 7, 2025, Takeda Pharmaceuticals America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of FIRAZYR?The most common side effects of FIRAZYR include: redness, bruising, swelling, warmth, burning, itching, irritation, hives, numbness, pressure, or pain at the injection site fever too much of an enzyme called transaminase in your blood dizziness nausea headache rash Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of FIRAZYR. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective July 7, 2025 (SPL set ed6657ca-ab68-477a-9968-e12dc928b540), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials.
Table 1 Adverse reactions observed in >1% of patients with acute attacks of HAE and at a higher rate with FIRAZYR versus placebo in the placebo-controlled trials Events occurring within 14 days of study drug…
| System Organ Class Preferred Term | FIRAZYR (N =77) Subjects (%) | Placebo (N = 75) Subjects (%) |
|---|---|---|
| Injection site reaction Injection site bruising, Injection site hematoma, Injection site… | 75 (97) | 25 (33) |
| Pyrexia | 3 (4) | 0 |
| Transaminase increased | 3 (4) | 0 |
| Dizziness | 2 (3) | 1 (1) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The safety of icatibant was evaluated in three controlled trials that included 223 patients who received FIRAZYR 30 mg (n=113), placebo (n=75), or comparator (n=38). The mean age at study entry was 38 years (range 18 to 83 years), 64% were female, and 95% were white. The data described below represent adverse reactions observed from the two placebo-controlled trials, consisting of 77 patients who received FIRAZYR at a dose of 30 mg SC, and 75 who received placebo. The most frequently reported adverse reactions (occurring in greater than 1% of patients and at a higher rate with FIRAZYR versus placebo) are shown in Table 1. Because clinical trials are conducted under widely varying conditions, adverse reaction 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.
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective July 7, 2025 (SPL set ed6657ca-ab68-477a-9968-e12dc928b540), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,823 reports list icatibant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 284 are coded as a death and 3,582 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Icatibant: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions