ICATIBANT ACETATE

N/A

Manufactured by Takeda Pharmaceuticals America, Inc.

12,796 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ICATIBANT ACETATE

ICATIBANT ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. The most commonly reported adverse reactions for ICATIBANT ACETATE include HEREDITARY ANGIOEDEMA, DRUG INEFFECTIVE, PRODUCT DOSE OMISSION ISSUE, WEIGHT DECREASED, WEIGHT INCREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ICATIBANT ACETATE.

Top Adverse Reactions

HEREDITARY ANGIOEDEMA2,364 reports
DRUG INEFFECTIVE461 reports
PRODUCT DOSE OMISSION ISSUE414 reports
WEIGHT DECREASED370 reports
WEIGHT INCREASED349 reports
INJECTION SITE PAIN288 reports
OFF LABEL USE259 reports
PRODUCT USE ISSUE240 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION236 reports
HEADACHE217 reports
COVID 19189 reports
STRESS180 reports
CONDITION AGGRAVATED177 reports
MALAISE177 reports
NAUSEA168 reports
FATIGUE158 reports
NO ADVERSE EVENT158 reports
FALL154 reports
PHARYNGEAL SWELLING153 reports
PAIN152 reports
INSURANCE ISSUE150 reports
PRESCRIBED OVERDOSE146 reports
DYSPNOEA143 reports
VOMITING140 reports
DIZZINESS136 reports
INJECTION SITE ERYTHEMA130 reports
PNEUMONIA130 reports
INTENTIONAL PRODUCT USE ISSUE129 reports
PHARYNGEAL OEDEMA128 reports
LARYNGEAL OEDEMA126 reports
ABDOMINAL DISTENSION123 reports
ABDOMINAL PAIN117 reports
DEATH116 reports
SWELLING115 reports
DIARRHOEA113 reports
URTICARIA112 reports
HOSPITALISATION108 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION99 reports
ILLNESS98 reports
SINUSITIS95 reports
INFLUENZA92 reports
PRODUCT USE IN UNAPPROVED INDICATION92 reports
SWELLING FACE92 reports
INJECTION SITE SWELLING87 reports
NASOPHARYNGITIS87 reports
SWOLLEN TONGUE87 reports
PERIPHERAL SWELLING82 reports
GASTROINTESTINAL DISORDER79 reports
RASH79 reports
THROMBOSIS76 reports
POOR VENOUS ACCESS72 reports
PRODUCT AVAILABILITY ISSUE72 reports
URINARY TRACT INFECTION71 reports
ASTHENIA70 reports
INJECTION SITE BRUISING70 reports
PRURITUS70 reports
PYREXIA70 reports
HYPERSENSITIVITY69 reports
CHEST PAIN67 reports
COUGH67 reports
ABDOMINAL PAIN UPPER65 reports
ANAPHYLACTIC REACTION58 reports
ANXIETY58 reports
INFECTION58 reports
MIGRAINE58 reports
DEVICE RELATED INFECTION56 reports
THERAPY INTERRUPTED56 reports
ARTHRALGIA55 reports
BACK PAIN55 reports
ANGIOEDEMA54 reports
LOSS OF CONSCIOUSNESS54 reports
PRODUCT DISTRIBUTION ISSUE54 reports
BLOOD PRESSURE INCREASED53 reports
CONTUSION53 reports
INJECTION SITE REACTION53 reports
WEIGHT FLUCTUATION52 reports
ROAD TRAFFIC ACCIDENT51 reports
EXPOSURE DURING PREGNANCY50 reports
MATERNAL EXPOSURE DURING PREGNANCY50 reports
PRODUCT DOSE OMISSION IN ERROR50 reports
DRUG HYPERSENSITIVITY48 reports
SEPSIS47 reports
NEPHROLITHIASIS46 reports
FEELING ABNORMAL45 reports
ABDOMINAL DISCOMFORT44 reports
CARDIAC DISORDER44 reports
UNEVALUABLE EVENT44 reports
UPPER RESPIRATORY TRACT INFECTION43 reports
HEART RATE INCREASED42 reports
PAIN IN EXTREMITY42 reports
SEIZURE42 reports
DEHYDRATION41 reports
EXPIRED PRODUCT ADMINISTERED41 reports
LIP SWELLING40 reports
CEREBROVASCULAR ACCIDENT39 reports
BRONCHITIS38 reports
INJECTION SITE PRURITUS38 reports
MUSCLE SPASMS38 reports
INJECTION SITE URTICARIA36 reports
LIMB INJURY36 reports

Report Outcomes

Out of 5,451 classified reports for ICATIBANT ACETATE:

Serious 67.6%Non-Serious 32.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female3,552 (78.8%)
Male940 (20.9%)
Unknown14 (0.3%)

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ICATIBANT ACETATE?

This profile reflects 12,796 FDA FAERS reports that mention ICATIBANT ACETATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ICATIBANT ACETATE?

Frequently reported terms in FAERS include HEREDITARY ANGIOEDEMA, DRUG INEFFECTIVE, PRODUCT DOSE OMISSION ISSUE, WEIGHT DECREASED, WEIGHT INCREASED, INJECTION SITE PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ICATIBANT ACETATE?

Labeling and FAERS entries often list Takeda Pharmaceuticals America, Inc. in connection with ICATIBANT ACETATE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.