Aminocaproic Acid side effects: what 764 FDA adverse event reports show
Drug class
Antifibrinolytic Agent
Who reports
764 reports · 76% serious · 141 with death outcome · 34% female
Used for
Aminocaproic Acid Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required. Fibrinolytic bl.
What it is
DESCRIPTION Aminocaproic Acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis.
Boxed warning
None in the current label
Causality screen of the 16 strongest signals
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
- 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. 6 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Gingival bleeding | 18 | 36.1 22.9–57.0ROR 37.0 · χ² 580 / p 2e-128 | 34.9 EB05 23.3 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 24.9 | no trial data cached |
| Haemorrhage | 129 | 33.9 28.9–39.6ROR 40.5 · χ² 4,097 / p <1e-300 | 33.7 EB05 29.1 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.1 · ♀ 8% (drug 34%) | no trial data cached |
| Post procedural haemorrhage | 9 | 21.1 11.0–40.5ROR 21.4 · χ² 153 / p 2e-35 | 19.7 EB05 10.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 17.8 | no trial data cached |
| Epistaxis (nosebleed) | 49 | 17.9 13.7–23.5ROR 19.1 · χ² 769 / p 2e-169 | 17.8 EB05 14.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 | no trial data cached |
| Head injury | 20 | 17.4 11.3–26.8ROR 17.8 · χ² 293 / p 7e-66 | 16.9 EB05 11.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 10% (drug 34%) | no trial data cached |
| Joint injury | 12 | 15.4 8.8–27.0ROR 15.6 · χ² 147 / p 3e-34 | 14.2 EB05 7.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Limb injury | 14 | 14.2 8.4–23.8ROR 14.4 · χ² 159 / p 1e-36 | 13.1 EB05 7.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Multi-organ failure | 9 | 14.1 7.3–26.9ROR 14.2 · χ² 97 / p 4e-23 | 11.9 EB05 5.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Ligament sprain | 5 | 13.9 5.8–33.3ROR 14.0 · χ² 48 / p 3e-12 | 9.5 EB05 3.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Bronchospasm (airway tightening) | 7 | 13.4 6.4–28.0ROR 13.5 · χ² 68 / p 6e-17 | 10.4 EB05 4.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Eye haemorrhage | 6 | 12.3 5.5–27.3ROR 12.4 · χ² 52 / p 4e-13 | 8.7 EB05 3.6 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.9 | no trial data cached |
| Anhedonia | 10 | 10.4 5.6–19.2ROR 10.5 · χ² 75 / p 2e-18 | 8.3 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Myelodysplastic syndrome | 5 | 9.5 4.0–22.7ROR 9.5 · χ² 30 / p 2e-8 | 6.0 EB05 2.6 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Fluid overload | 5 | 9.3 3.9–22.3ROR 9.3 · χ² 29 / p 3e-8 | 5.9 EB05 2.6 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Fear | 9 | 9.1 4.8–17.4ROR 9.2 · χ² 57 / p 2e-14 | 6.9 EB05 3.7 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Acute myeloid leukaemia | 5 | 8.8 3.7–21.1ROR 8.9 · χ² 27 / p 9e-8 | 5.6 EB05 2.5 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Haemorrhage | 129 | 33.9 28.9–39.6ROR 40.5 · χ² 4,097 / p <1e-300 | 33.7 EB05 29.1 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.1 · ♀ 8% (drug 34%) | no trial data cached |
| Epistaxis (nosebleed) | 49 | 17.9 13.7–23.5ROR 19.1 · χ² 769 / p 2e-169 | 17.8 EB05 14.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 | no trial data cached |
| Head injury | 20 | 17.4 11.3–26.8ROR 17.8 · χ² 293 / p 7e-66 | 16.9 EB05 11.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 10% (drug 34%) | no trial data cached |
| Gingival bleeding | 18 | 36.1 22.9–57.0ROR 37.0 · χ² 580 / p 2e-128 | 34.9 EB05 23.3 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 24.9 | no trial data cached |
| Limb injury | 14 | 14.2 8.4–23.8ROR 14.4 · χ² 159 / p 1e-36 | 13.1 EB05 7.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Joint injury | 12 | 15.4 8.8–27.0ROR 15.6 · χ² 147 / p 3e-34 | 14.2 EB05 7.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Anhedonia | 10 | 10.4 5.6–19.2ROR 10.5 · χ² 75 / p 2e-18 | 8.3 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Fear | 9 | 9.1 4.8–17.4ROR 9.2 · χ² 57 / p 2e-14 | 6.9 EB05 3.7 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Multi-organ failure | 9 | 14.1 7.3–26.9ROR 14.2 · χ² 97 / p 4e-23 | 11.9 EB05 5.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Post procedural haemorrhage | 9 | 21.1 11.0–40.5ROR 21.4 · χ² 153 / p 2e-35 | 19.7 EB05 10.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 17.8 | no trial data cached |
| Bronchospasm (airway tightening) | 7 | 13.4 6.4–28.0ROR 13.5 · χ² 68 / p 6e-17 | 10.4 EB05 4.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Eye haemorrhage | 6 | 12.3 5.5–27.3ROR 12.4 · χ² 52 / p 4e-13 | 8.7 EB05 3.6 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.9 | no trial data cached |
| Acute myeloid leukaemia | 5 | 8.8 3.7–21.1ROR 8.9 · χ² 27 / p 9e-8 | 5.6 EB05 2.5 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Fluid overload | 5 | 9.3 3.9–22.3ROR 9.3 · χ² 29 / p 3e-8 | 5.9 EB05 2.6 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Myelodysplastic syndrome | 5 | 9.5 4.0–22.7ROR 9.5 · χ² 30 / p 2e-8 | 6.0 EB05 2.6 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | 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.
- Epistaxis — n=49, PRR 17.9
- Head injury — n=20, PRR 17.4
✓ 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 Aminocaproic Acid?
In FDA FAERS, the most frequently co-reported reaction terms for Aminocaproic Acid are haemorrhage, epistaxis, head injury, gingival bleeding, limb injury, joint injury. 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 Aminocaproic Acid have an FDA boxed warning?
No. The FDA label retrieved for Aminocaproic Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Aminocaproic 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 08bfb83e-3ac5-4e66-84a3-fcd4deaf73ae, effective 20200716; matched on
openfda.generic_name.exact:"AMINOCAPROIC 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, 22 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.