Prescription medicine
Icatibant Brand names: Firazyr, Sajazir
Icatibant (Sajazir) is a prescription medicine with an FDA approval on record since 2011. FDA's NDC Directory lists it from 8 generic labelers.
- 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 NDA 22150 record on Drugs@FDA; every icatibant label on DailyMed.
Highlights of the record
FDA label of July 7, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFIRAZYR ® (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Forms and strengths
- 10 mg/ml
- 30 mg/3ml
Injection (solution); injection.
On the market
- Earliest approval on file
- August 25, 2011 Firazyr, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first July 15, 2019; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,823 through July 30, 2026
What is icatibant used for?
From the label: indications and usageFIRAZYR ® (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. FIRAZYR is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
FDA pharmacologic class: Bradykinin B2 Receptor Antagonist.
Source: FDA drug label (Firazyr), 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 patient leaflet for icatibant say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using FIRAZYR?Tiredness, drowsiness, and dizziness can happen in people who take FIRAZYR. If this happens, do not drive a car, use machinery, or do anything that needs you to be alert.
From the patient leaflet: How should I store FIRAZYR?Store FIRAZYR between 36°F to 77°F (2°C to 25°C). Do not freeze. Store FIRAZYR in the original carton until you are ready to use it. Keep FIRAZYR and all medicines out of the reach of children.
Source: FDA drug label (Firazyr), Takeda Pharmaceuticals America, Inc., effective July 7, 2025 (SPL set ed6657ca-ab68-477a-9968-e12dc928b540), via openFDA; the full label on DailyMed
Is there a generic for icatibant (Sajazir)?
The FDA approved the first generic icatibant on July 15, 2019. 10 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists icatibant from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2011 earliest approval on file
- 2019 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is icatibant in shortage?
No icatibant presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated May 7, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-86) | Fresenius Kabi USA, LLC | To Be Discontinued | May 7, 2026 |
| Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-93) | Fresenius Kabi USA, LLC | To Be Discontinued | May 7, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What do FAERS reports show for icatibant?
The FDA Adverse Event Reporting System holds 8,823 reports that list icatibant among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Icatibant side effects
- the label's list beside FAERS reports
- Icatibant shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other