Drug · FAERS side-effect profile with label screen
Tranexamic Acid side effects: what 8,839 FDA adverse event reports show
Drug class
Antifibrinolytic Agent
FDA label (Established Pharmacologic Class)
Who reports
8,839 reports · 93% serious · 1,316 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Tranexamic acid USP tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential . Tranexamic acid USP tablets is an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential. ( 1 )
FDA label, Indications and Usage
What it is
Tranexamic acid USP tablets is an antifibrinolytic drug administered orally.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 4Reporting / coding artifact 6Lab value / disease marker 1Not in label — unassessed 28
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 991 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Mechanical ventilation complication | 25 | 475.5 309.4–730.5ROR 476.8 · χ² 9,447 / p <1e-300 | 303.5 EB05 216.2 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=25 · ♀ 0% (drug 58%) · 100% clinician | no trial data cached |
| Post procedural hypotension | 11 | 352.5 187.1–664.2ROR 352.9 · χ² 3,052 / p <1e-300 | 200.4 EB05 119.4 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial data cached |
| Inspiratory capacity decreased | 26 | 247.2 165.1–370.2ROR 248.0 · χ² 5,546 / p <1e-300 | 192.3 EB05 137.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 58%) · 100% clinician | no trial data cached |
| Renal cortical necrosis | 17 | 189.4 115.6–310.3ROR 189.7 · χ² 2,775 / p <1e-300 | 146.7 EB05 97.0 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=17 | no trial data cached |
| Red blood cell transfusion | 16 | 98.8 59.9–162.8ROR 98.9 · χ² 1,393 / p <1e-300 | 85.4 EB05 55.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Fallopian tube disorder | 11 | 90.9 49.8–166.0ROR 91.0 · χ² 857 / p 1e-188 | 76.4 EB05 45.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Adnexal torsion | 11 | 85.2 46.7–155.5ROR 85.3 · χ² 804 / p 4e-177 | 72.3 EB05 43.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Biliary sepsis | 14 | 74.1 43.5–126.1ROR 74.2 · χ² 909 / p 6e-200 | 65.7 EB05 41.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Maternal exposure during delivery | 29 | 72.9 50.4–105.5ROR 73.2 · χ² 1,926 / p <1e-300 | 67.7 EB05 49.5 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=22 · ♀ 100% (drug 58%) · 100% clinician | no trial data cached |
| Enterococcal sepsis | 21 | 62.6 40.6–96.5ROR 62.7 · χ² 1,180 / p 6e-259 | 57.9 EB05 40.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 86% (drug 58%) | no trial data cached |
| Cerebral venous sinus thrombosis | 21 | 62.3 40.4–96.1ROR 62.5 · χ² 1,176 / p 6e-258 | 57.7 EB05 39.8 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=21 · ♀ 100% (drug 58%) · 100% clinician | no trial data cached |
| Acute left ventricular failure | 14 | 50.1 29.5–85.0ROR 50.2 · χ² 612 / p 2e-135 | 46.2 EB05 29.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Aplastic anaemia | 105 | 48.4 40.0–58.7ROR 49.0 · χ² 4,735 / p <1e-300 | 47.1 EB05 40.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=105 · 98% clinician | no trial data cached |
| Joint ankylosis | 11 | 46.4 25.5–84.2ROR 46.4 · χ² 435 / p 6e-97 | 42.4 EB05 25.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Myoclonic epilepsy | 27 | 44.3 30.3–64.7ROR 44.4 · χ² 1,078 / p 8e-237 | 42.3 EB05 30.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=27 · 100% clinician | no trial data cached |
| Factor viii inhibition | 18 | 41.1 25.8–65.4ROR 41.2 · χ² 653 / p 3e-144 | 38.9 EB05 26.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Haemothorax | 46 | 38.1 28.5–51.0ROR 38.3 · χ² 1,601 / p <1e-300 | 37.0 EB05 28.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 12% (drug 58%) · 100% clinician | no trial data cached |
| Platelet transfusion | 19 | 35.8 22.8–56.3ROR 35.9 · χ² 599 / p 1e-132 | 34.2 EB05 23.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Basophil count increased | 10 | 31.9 17.1–59.5ROR 31.9 · χ² 266 / p 5e-60 | 29.8 EB05 17.2 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Wrong product administered | 86 | 31.1 25.2–38.4ROR 31.4 · χ² 2,444 / p <1e-300 | 30.5 EB05 25.5 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=85 · 98% clinician | no trial data cached |
| Vasodilatation | 32 | 30.5 21.6–43.3ROR 30.6 · χ² 874 / p 2e-192 | 29.7 EB05 22.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% clinician | no trial data cached |
| Perforation | 10 | 30.2 16.2–56.3ROR 30.2 · χ² 251 / p 1e-56 | 28.3 EB05 16.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Coronary artery thrombosis | 24 | 28.4 19.0–42.5ROR 28.5 · χ² 601 / p 6e-133 | 27.6 EB05 19.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | no trial data cached |
| Fibroma | 11 | 28.4 15.7–51.5ROR 28.4 · χ² 261 / p 6e-59 | 26.8 EB05 15.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Bronchial hyperreactivity | 14 | 27.9 16.5–47.2ROR 27.9 · χ² 333 / p 1e-74 | 26.7 EB05 16.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Hereditary angioedema | 121 | 27.6 23.1–33.0ROR 28.0 · χ² 3,045 / p <1e-300 | 27.2 EB05 23.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.3 · ♀ 87% (drug 58%) | no trial data cached |
| Myoclonus | 131 | 26.3 22.2–31.2ROR 26.7 · χ² 3,134 / p <1e-300 | 26.0 EB05 22.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · 100% clinician | no trial data cached |
| Product appearance confusion | 10 | 26.3 14.1–49.0ROR 26.3 · χ² 216 / p 3e-49 | 24.7 EB05 14.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Haemorrhagic disorder | 12 | 26.2 14.8–46.3ROR 26.2 · χ² 263 / p 2e-59 | 24.9 EB05 15.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Stridor | 32 | 26.0 18.4–36.9ROR 26.1 · χ² 737 / p 1e-162 | 25.4 EB05 18.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=32 · 100% clinician | no trial data cached |
| Hyporesponsive to stimuli | 12 | 25.0 14.2–44.2ROR 25.1 · χ² 251 / p 1e-56 | 23.8 EB05 14.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Product packaging confusion | 25 | 24.6 16.6–36.5ROR 24.7 · χ² 537 / p 4e-119 | 24.0 EB05 17.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=19 · 100% clinician | no trial data cached |
| Postpartum haemorrhage | 13 | 23.7 13.7–40.9ROR 23.8 · χ² 258 / p 2e-58 | 22.7 EB05 13.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Vascular stent thrombosis | 20 | 23.5 15.2–36.6ROR 23.6 · χ² 405 / p 2e-90 | 22.9 EB05 15.6 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | no trial data cached |
| Uterine disorder | 23 | 23.5 15.6–35.4ROR 23.5 · χ² 468 / p 4e-104 | 22.9 EB05 16.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Local anaesthetic systemic toxicity | 10 | 23.1 12.4–43.0ROR 23.1 · χ² 188 / p 4e-43 | 21.7 EB05 12.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Immune thrombocytopenia | 43 | 23.0 17.0–31.0ROR 23.1 · χ² 875 / p 2e-192 | 22.6 EB05 17.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 25% (drug 58%) | no trial data cached |
| Arterial haemorrhage | 11 | 22.9 12.7–41.5ROR 22.9 · χ² 207 / p 3e-47 | 21.7 EB05 12.5 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Abscess oral | 12 | 21.0 11.9–37.1ROR 21.1 · χ² 208 / p 2e-47 | 20.0 EB05 11.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Retinal artery occlusion | 21 | 19.9 13.0–30.6ROR 19.9 · χ² 355 / p 1e-79 | 19.4 EB05 13.2 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=21 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 642 | 1.2 1.1–1.2ROR 1.2 · χ² 14 / p 8e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Off label use (used outside approved label) | 642 | 1.8 1.6–1.9ROR 1.8 · χ² 217 / p 3e-49 | 1.8 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Pyrexia (fever) | 366 | 2.5 2.3–2.8ROR 2.6 · χ² 336 / p 3e-75 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Nausea | 340 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.351 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Hypotension (low blood pressure) | 325 | 3.9 3.5–4.3ROR 4.0 · χ² 689 / p 3e-152 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · 92% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 313 | 1.2 1.0–1.3ROR 1.2 · χ² 6 / p 0.005 | 1.2 EB05 1.1 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Vomiting | 304 | 1.5 1.4–1.7ROR 1.6 · χ² 58 / p 1e-14 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Haemorrhage | 302 | 6.9 6.1–7.7ROR 7.1 · χ² 1,511 / p <1e-300 | 6.8 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Dyspnoea (shortness of breath) | 287 | 1.2 1.1–1.3ROR 1.2 · χ² 10 / p 8e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Pneumonia (lung infection) | 274 | 2.0 1.8–2.3ROR 2.0 · χ² 140 / p 1e-32 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.3 · 90% clinician | no trial data cached |
| Febrile neutropenia | 261 | 9.4 8.3–10.6ROR 9.6 · χ² 1,944 / p <1e-300 | 9.3 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 36% (drug 58%) · 97% clinician | no trial data cached |
| Headache | 241 | 0.9 0.8–1.0ROR 0.9 · χ² 2 / p 0.080 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 · ♀ 80% (drug 58%) | no trial data cached |
| Anaemia (low red blood cells) | 231 | 2.9 2.5–3.3ROR 2.9 · χ² 282 / p 1e-63 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 228 | 9.9 8.7–11.2ROR 10.1 · χ² 1,808 / p <1e-300 | 9.8 EB05 8.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 94% clinician | no trial data cached |
| Fatigue (tiredness) | 226 | 0.7 0.6–0.8ROR 0.7 · χ² 32 / p 6e-9 | 0.7 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.7 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Inspiratory capacity decreased — n=26, PRR 247.2
- Enterococcal sepsis — n=21, PRR 62.6
- Aplastic anaemia — n=105, PRR 48.4
- Myoclonic epilepsy — n=27, PRR 44.3
- Haemothorax — n=46, PRR 38.1
- Vasodilatation — n=32, PRR 30.5
- Coronary artery thrombosis — n=24, PRR 28.4
- Hereditary angioedema — n=121, PRR 27.6
- Myoclonus — n=131, PRR 26.3
- Stridor — n=32, PRR 26.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Tranexamic Acid?
In FDA FAERS, the most frequently co-reported reaction terms for Tranexamic Acid are pyrexia, nausea, hypotension, diarrhoea, vomiting, haemorrhage. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Tranexamic Acid have an FDA boxed warning?
No. The FDA label retrieved for Tranexamic Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tranexamic Acid causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 031bf7c2-3b07-469d-bc5a-31fc6238e25f, effective 20250929; matched on
openfda.generic_name.exact:"TRANEXAMIC ACID") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,031 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.