Argatroban side effects: what 1,496 FDA adverse event reports show
Drug class
Anti-coagulant, Direct Thrombin Inhibitor
Who reports
1,496 reports · 87% serious · 318 with death outcome · 45% female
Used for
Argatroban in Sodium Chloride injection is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) ( 1.1 ) As an anticoagulant in adult patients with or at risk for.
What it is
Argatroban is a synthetic direct thrombin inhibitor.
Boxed warning
None in the current label
Causality screen of the 27 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. 18 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 |
|---|---|---|---|---|---|---|
| International normalised ratio increased | 110 | 53.8 44.9–64.4ROR 58.0 · χ² 5,632 / p <1e-300 | 53.1 EB05 45.3 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.6 · 93% clinician | no trial data cached |
| Disseminated intravascular coagulation | 38 | 37.8 27.6–51.8ROR 38.8 · χ² 1,324 / p 4e-290 | 37.1 EB05 28.2 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.3 · 92% clinician | no trial data cached |
| Subarachnoid haemorrhage | 25 | 34.4 23.3–50.8ROR 35.0 · χ² 776 / p 4e-171 | 33.5 EB05 23.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · 96% clinician | no trial data cached |
| Coagulopathy | 35 | 29.6 21.3–41.1ROR 30.3 · χ² 938 / p 3e-206 | 29.1 EB05 21.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 · 93% clinician | no trial data cached |
| Cerebral infarction | 50 | 28.7 21.9–37.7ROR 29.7 · χ² 1,310 / p 5e-287 | 28.4 EB05 22.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.5 | no trial data cached |
| Cardiogenic shock | 22 | 21.7 14.3–32.8ROR 22.0 · χ² 413 / p 5e-92 | 21.2 EB05 14.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 · 100% clinician | no trial data cached |
| Cerebral haemorrhage | 38 | 14.9 10.9–20.4ROR 15.3 · χ² 480 / p 1e-106 | 14.7 EB05 11.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 68 | 14.6 11.6–18.4ROR 15.3 · χ² 851 / p 2e-187 | 14.5 EB05 11.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Multi-organ failure | 18 | 14.4 9.1–22.8ROR 14.6 · χ² 211 / p 4e-48 | 13.7 EB05 8.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Haemorrhage | 80 | 10.7 8.7–13.3ROR 11.3 · χ² 700 / p 2e-154 | 10.5 EB05 8.7 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Multiple organ dysfunction syndrome | 21 | 10.6 6.9–16.2ROR 10.7 · χ² 172 / p 1e-39 | 9.6 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Pulmonary embolism (lung blood clot) | 70 | 10.3 8.2–12.9ROR 10.7 · χ² 580 / p 2e-128 | 10.0 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Haemorrhage intracranial | 11 | 10.3 5.7–18.5ROR 10.4 · χ² 83 / p 4e-20 | 8.4 EB05 4.6 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Thrombosis | 55 | 9.6 7.4–12.4ROR 9.9 · χ² 415 / p 2e-92 | 9.2 EB05 7.2 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.4 | no trial data cached |
| Melaena (black stool) | 15 | 9.5 5.8–15.8ROR 9.6 · χ² 106 / p 3e-25 | 8.1 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Thrombocytopenia (low platelets) | 69 | 8.7 6.9–10.9ROR 9.1 · χ² 464 / p 4e-103 | 8.4 EB05 6.8 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.8 · 92% clinician | no trial data cached |
| Gastrointestinal haemorrhage | 52 | 8.7 6.6–11.3ROR 9.0 · χ² 347 / p 1e-77 | 8.3 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · ♀ 22% (drug 45%) | no trial data cached |
| Ischaemic stroke | 11 | 8.6 4.8–15.6ROR 8.7 · χ² 67 / p 1e-16 | 6.9 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Haematemesis (vomiting blood) | 15 | 8.3 5.0–13.7ROR 8.4 · χ² 89 / p 2e-21 | 7.0 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Haematoma | 15 | 8.1 4.9–13.4ROR 8.2 · χ² 86 / p 8e-21 | 6.8 EB05 4.3 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Haemoptysis | 16 | 8.0 4.9–13.1ROR 8.1 · χ² 92 / p 5e-22 | 6.8 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Hepatic function abnormal | 21 | 8.0 5.2–12.2ROR 8.0 · χ² 121 / p 2e-28 | 7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Drug resistance | 14 | 7.6 4.5–12.9ROR 7.7 · χ² 74 / p 3e-18 | 6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Renal failure acute | 21 | 6.8 4.5–10.5ROR 6.9 · χ² 99 / p 1e-23 | 6.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Unresponsive to stimuli | 11 | 6.0 3.3–10.8ROR 6.0 · χ² 41 / p 8e-11 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Liver function test abnormal | 12 | 5.8 3.3–10.1ROR 5.8 · χ² 43 / p 3e-11 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 14 | 4.7 2.8–7.9ROR 4.8 · χ² 37 / p 5e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | 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 |
|---|---|---|---|---|---|---|
| International normalised ratio increased | 110 | 53.8 44.9–64.4ROR 58.0 · χ² 5,632 / p <1e-300 | 53.1 EB05 45.3 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.6 · 93% clinician | no trial data cached |
| Haemorrhage | 80 | 10.7 8.7–13.3ROR 11.3 · χ² 700 / p 2e-154 | 10.5 EB05 8.7 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Pulmonary embolism (lung blood clot) | 70 | 10.3 8.2–12.9ROR 10.7 · χ² 580 / p 2e-128 | 10.0 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Thrombocytopenia (low platelets) | 69 | 8.7 6.9–10.9ROR 9.1 · χ² 464 / p 4e-103 | 8.4 EB05 6.8 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.8 · 92% clinician | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 68 | 14.6 11.6–18.4ROR 15.3 · χ² 851 / p 2e-187 | 14.5 EB05 11.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Thrombosis | 55 | 9.6 7.4–12.4ROR 9.9 · χ² 415 / p 2e-92 | 9.2 EB05 7.2 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.4 | no trial data cached |
| Gastrointestinal haemorrhage | 52 | 8.7 6.6–11.3ROR 9.0 · χ² 347 / p 1e-77 | 8.3 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · ♀ 22% (drug 45%) | no trial data cached |
| Cerebral infarction | 50 | 28.7 21.9–37.7ROR 29.7 · χ² 1,310 / p 5e-287 | 28.4 EB05 22.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.5 | no trial data cached |
| Cerebral haemorrhage | 38 | 14.9 10.9–20.4ROR 15.3 · χ² 480 / p 1e-106 | 14.7 EB05 11.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Disseminated intravascular coagulation | 38 | 37.8 27.6–51.8ROR 38.8 · χ² 1,324 / p 4e-290 | 37.1 EB05 28.2 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.3 · 92% clinician | no trial data cached |
| Coagulopathy | 35 | 29.6 21.3–41.1ROR 30.3 · χ² 938 / p 3e-206 | 29.1 EB05 21.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 · 93% clinician | no trial data cached |
| Subarachnoid haemorrhage | 25 | 34.4 23.3–50.8ROR 35.0 · χ² 776 / p 4e-171 | 33.5 EB05 23.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · 96% clinician | no trial data cached |
| Cardiogenic shock | 22 | 21.7 14.3–32.8ROR 22.0 · χ² 413 / p 5e-92 | 21.2 EB05 14.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 · 100% clinician | no trial data cached |
| Renal failure acute | 21 | 6.8 4.5–10.5ROR 6.9 · χ² 99 / p 1e-23 | 6.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Hepatic function abnormal | 21 | 8.0 5.2–12.2ROR 8.0 · χ² 121 / p 2e-28 | 7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | 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.
- Subarachnoid haemorrhage — n=25, PRR 34.4
- Coagulopathy — n=35, PRR 29.6
- Cerebral infarction — n=50, PRR 28.7
- Cardiogenic shock — n=22, PRR 21.7
- Cerebral haemorrhage — n=38, PRR 14.9
- Deep vein thrombosis — n=68, PRR 14.6
- Multiple organ dysfunction syndrome — n=21, PRR 10.6
- Pulmonary embolism — n=70, PRR 10.3
- Renal failure acute — n=21, PRR 6.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Argatroban ↔ Haemorrhage.
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 Argatroban?
In FDA FAERS, the most frequently co-reported reaction terms for Argatroban are international normalised ratio increased, haemorrhage, pulmonary embolism, thrombocytopenia, deep vein thrombosis, thrombosis. 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 Argatroban have an FDA boxed warning?
No. The FDA label retrieved for Argatroban has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Argatroban 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 46cdf9e6-839c-49c8-9ee1-c30cfdd9368d, effective 20260521; matched on
openfda.generic_name.exact:"ARGATROBAN") - 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, 45 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.