AMINOCAPROIC ACID

N/A

Manufactured by American Regent, Inc.

1,338 FDA adverse event reports analyzed

Last updated: 2026-04-15

About AMINOCAPROIC ACID

AMINOCAPROIC ACID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by American Regent, Inc.. The most commonly reported adverse reactions for AMINOCAPROIC ACID include HAEMORRHAGE, OFF LABEL USE, DRUG INEFFECTIVE, DEATH, EPISTAXIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMINOCAPROIC ACID.

Top Adverse Reactions

HAEMORRHAGE94 reports
OFF LABEL USE60 reports
DRUG INEFFECTIVE45 reports
DEATH37 reports
EPISTAXIS33 reports
PAIN28 reports
HAEMARTHROSIS27 reports
HYPOTENSION27 reports
FALL25 reports
THROMBOCYTOPENIA24 reports
PYREXIA22 reports
CONTUSION20 reports
MOUTH HAEMORRHAGE20 reports
ANAEMIA19 reports
PLATELET COUNT DECREASED19 reports
RENAL FAILURE19 reports
ANXIETY18 reports
DEEP VEIN THROMBOSIS18 reports
FATIGUE18 reports
INJURY18 reports
DYSPNOEA17 reports
ATRIAL FIBRILLATION16 reports
NAUSEA16 reports
RESPIRATORY FAILURE16 reports
UNEVALUABLE EVENT16 reports
GASTROINTESTINAL HAEMORRHAGE15 reports
GINGIVAL BLEEDING15 reports
HEADACHE15 reports
HYPERSENSITIVITY15 reports
PNEUMONIA15 reports
CARDIAC ARREST14 reports
DIABETES INSIPIDUS14 reports
RENAL FAILURE ACUTE14 reports
RENAL IMPAIRMENT14 reports
HEAD INJURY13 reports
DIARRHOEA12 reports
EMOTIONAL DISTRESS12 reports
HEPARIN INDUCED THROMBOCYTOPENIA12 reports
HYPERTENSION12 reports
HYPOXIA12 reports
LIMB INJURY12 reports
PAIN IN EXTREMITY12 reports
VOMITING12 reports
ANGIOEDEMA11 reports
DIZZINESS11 reports
SEIZURE11 reports
WEIGHT INCREASED11 reports
ACUTE KIDNEY INJURY10 reports
ANHEDONIA10 reports
ARTHRALGIA10 reports
FEBRILE NEUTROPENIA10 reports
JOINT INJURY10 reports
PANCYTOPENIA10 reports
COUGH9 reports
FEAR9 reports
MULTI ORGAN FAILURE9 reports
NO ADVERSE EVENT9 reports
PULMONARY EMBOLISM9 reports
ANAPHYLACTIC REACTION8 reports
ASTHENIA8 reports
BLOOD BILIRUBIN INCREASED8 reports
DEPRESSION8 reports
HAEMOPTYSIS8 reports
RASH8 reports
RENAL INJURY8 reports
SEPSIS8 reports
TRAUMATIC HAEMORRHAGE8 reports
URTICARIA8 reports
BRONCHOSPASM7 reports
CHEST PAIN7 reports
CONDITION AGGRAVATED7 reports
HAEMOGLOBIN DECREASED7 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME7 reports
OEDEMA PERIPHERAL7 reports
POST PROCEDURAL COMPLICATION7 reports
PRODUCT DOSE OMISSION ISSUE7 reports
PULMONARY ALVEOLAR HAEMORRHAGE7 reports
PULMONARY OEDEMA7 reports
TACHYCARDIA7 reports
ABDOMINAL PAIN6 reports
COAGULOPATHY6 reports
DECREASED APPETITE6 reports
DISEASE PROGRESSION6 reports
ENCEPHALOPATHY6 reports
GENERAL PHYSICAL HEALTH DETERIORATION6 reports
HAEMATOMA6 reports
LIP HAEMORRHAGE6 reports
MALIGNANT NEOPLASM PROGRESSION6 reports
POST PROCEDURAL HAEMORRHAGE6 reports
PRODUCT USE IN UNAPPROVED INDICATION6 reports
STRESS6 reports
THERAPY NON RESPONDER6 reports
UNRESPONSIVE TO STIMULI6 reports
WEIGHT DECREASED6 reports
ACUTE MYELOID LEUKAEMIA5 reports
BLOOD PRESSURE INCREASED5 reports
BRADYCARDIA5 reports
CARDIAC FAILURE CONGESTIVE5 reports
CONSTIPATION5 reports
DRUG INDUCED LIVER INJURY5 reports

Report Outcomes

Out of 681 classified reports for AMINOCAPROIC ACID:

Serious 78.4%Non-Serious 21.6%

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

Male405 (64.5%)
Female221 (35.2%)
Unknown2 (0.3%)

Reports by Age

Age 617 reports
Age 5517 reports
Age 816 reports
Age 5214 reports
Age 5913 reports
Age 6713 reports
Age 7613 reports
Age 312 reports
Age 6512 reports
Age 1411 reports
Age 6011 reports
Age 6111 reports
Age 1310 reports
Age 7210 reports
Age 79 reports
Age 119 reports
Age 199 reports
Age 449 reports
Age 519 reports
Age 629 reports

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 AMINOCAPROIC ACID?

This profile reflects 1,338 FDA FAERS reports that mention AMINOCAPROIC ACID. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMINOCAPROIC ACID?

Frequently reported terms in FAERS include HAEMORRHAGE, OFF LABEL USE, DRUG INEFFECTIVE, DEATH, EPISTAXIS, PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMINOCAPROIC ACID?

Labeling and FAERS entries often list American Regent, Inc. in connection with AMINOCAPROIC ACID. 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.