TRANEXAMIC ACID

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

13,960 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TRANEXAMIC ACID

TRANEXAMIC ACID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for TRANEXAMIC ACID include OFF LABEL USE, DRUG INEFFECTIVE, PYREXIA, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRANEXAMIC ACID.

Top Adverse Reactions

OFF LABEL USE600 reports
DRUG INEFFECTIVE595 reports
PYREXIA346 reports
NAUSEA324 reports
DIARRHOEA301 reports
VOMITING297 reports
HYPOTENSION294 reports
HAEMORRHAGE279 reports
DYSPNOEA269 reports
PNEUMONIA266 reports
FEBRILE NEUTROPENIA257 reports
HEADACHE224 reports
ANAPHYLACTIC REACTION217 reports
ANAEMIA215 reports
FATIGUE214 reports
PLATELET COUNT DECREASED212 reports
SEIZURE198 reports
PULMONARY EMBOLISM182 reports
PAIN181 reports
DIZZINESS180 reports
MALAISE176 reports
TACHYCARDIA176 reports
THROMBOCYTOPENIA171 reports
RASH169 reports
DRUG INTERACTION163 reports
ACUTE KIDNEY INJURY162 reports
HAEMOGLOBIN DECREASED158 reports
ABDOMINAL PAIN157 reports
EPISTAXIS157 reports
DEATH155 reports
SEPSIS155 reports
URTICARIA154 reports
ARTHRALGIA153 reports
CARDIAC ARREST138 reports
HYPERTENSION136 reports
PRODUCT USE IN UNAPPROVED INDICATION133 reports
MYOCLONUS129 reports
BACK PAIN126 reports
GASTROINTESTINAL HAEMORRHAGE121 reports
COUGH119 reports
CONDITION AGGRAVATED116 reports
HEREDITARY ANGIOEDEMA116 reports
FALL113 reports
WEIGHT DECREASED112 reports
HYPERSENSITIVITY109 reports
PRURITUS109 reports
MUCOSAL INFLAMMATION108 reports
MATERNAL EXPOSURE DURING PREGNANCY107 reports
GENERALISED TONIC CLONIC SEIZURE105 reports
APLASTIC ANAEMIA103 reports
ANXIETY101 reports
ASTHENIA101 reports
CHEST PAIN101 reports
MUSCLE SPASMS98 reports
ALANINE AMINOTRANSFERASE INCREASED97 reports
DECREASED APPETITE97 reports
ANGIOEDEMA96 reports
INSOMNIA96 reports
CONTUSION94 reports
DISEASE PROGRESSION94 reports
DEEP VEIN THROMBOSIS93 reports
ANAPHYLACTIC SHOCK92 reports
PLEURAL EFFUSION89 reports
HAEMOPTYSIS88 reports
NEUTROPENIA88 reports
CHILLS87 reports
CONFUSIONAL STATE87 reports
THROMBOSIS87 reports
VAGINAL HAEMORRHAGE87 reports
ERYTHEMA86 reports
SYNCOPE86 reports
OEDEMA PERIPHERAL85 reports
PANCYTOPENIA85 reports
ACUTE MYOCARDIAL INFARCTION84 reports
BLOOD PRESSURE INCREASED84 reports
COVID 1984 reports
BLOOD PRESSURE DECREASED83 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION83 reports
LOSS OF CONSCIOUSNESS83 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION82 reports
PAIN IN EXTREMITY81 reports
SOMNOLENCE81 reports
WRONG PRODUCT ADMINISTERED81 reports
CONSTIPATION80 reports
OXYGEN SATURATION DECREASED80 reports
STATUS EPILEPTICUS80 reports
PRODUCT USE ISSUE79 reports
RENAL FAILURE79 reports
HYPOKALAEMIA78 reports
WEIGHT INCREASED78 reports
CEREBRAL INFARCTION75 reports
MELAENA73 reports
MYALGIA72 reports
HYPOXIA71 reports
WHITE BLOOD CELL COUNT DECREASED71 reports
MIGRAINE70 reports
RESPIRATORY FAILURE70 reports
EXPOSURE DURING PREGNANCY69 reports
RASH ERYTHEMATOUS69 reports
HEART RATE INCREASED68 reports

Report Outcomes

Out of 8,386 classified reports for TRANEXAMIC ACID:

Serious 93.3%Non-Serious 6.7%

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

Female4,315 (57.6%)
Male3,160 (42.2%)
Unknown15 (0.2%)

Reports by Age

Age 67135 reports
Age 72132 reports
Age 64127 reports
Age 76124 reports
Age 56123 reports
Age 71123 reports
Age 70121 reports
Age 69119 reports
Age 63118 reports
Age 49116 reports
Age 60116 reports
Age 77112 reports
Age 50110 reports
Age 34108 reports
Age 68108 reports
Age 14105 reports
Age 35105 reports
Age 62104 reports
Age 78104 reports
Age 53101 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 TRANEXAMIC ACID?

This profile reflects 13,960 FDA FAERS reports that mention TRANEXAMIC ACID. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TRANEXAMIC ACID?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, PYREXIA, NAUSEA, DIARRHOEA, VOMITING. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TRANEXAMIC ACID?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with TRANEXAMIC 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.