FDA Drug Adverse Events (FAERS)

Report 26951370v1

Serious

Report Type: 1

Reported information does not establish causation. The fact that an adverse event has been reported does not mean that the suspect drug caused the adverse event. The event may have been related to the underlying disease, other concurrent medications, or other factors.

Received

2026-06-30T00:00:00.000Z

FDA receipt

2026-06-30T00:00:00.000Z

Drugs

Reactions

reported from US

Patient information

Every demographic field FAERS publishes; most reports carry only some.

Age: Not reported
Age Group: Not reported
Sex: Female
Weight (kg): 171

Outcome and seriousness

The seriousness criteria the reporter marked, as published.

Serious Outcome: Yes
Death: No
Hospitalization: Yes
Life Threatening: No
Disabling: No
Congenital Anomaly: No
Other Important: No

Reported drugs

Suspect, concomitant and interacting drugs, with the role the reporter gave each.

ICATIBANT ACETATESuspect

ICATIBANT ACETATE

Not Attempted

Clinical Use

IndicationComplement deficiency disease

Action TakenNot reported

Administration Route

Subcutaneous

Dosage Form

Not reported

Dosage Details

FREQUENCY : AS NEEDED;

Frequency

Not reported

Cumulative Dose

N/A

Reported reactions (MedDRA)

The reporter's own MedDRA preferred terms, with each term's outcome.

Hereditary angioedemaJoint swellingPeripheral swellingAbdominal distensionSwelling faceLaryngeal oedema

Source record

The FAERS payload this page was built from, exactly as it landed.

Historical FDA Source Record

Local Archive

Version: 1