Tirofiban side effects: what 2,889 FDA adverse event reports show

Tirofiban · Tirofiban Hydrochloride · 45 reaction terms · 2,188 drug–reaction co-reports · data 2026-09-14

Drug class

Platelet aggregation inhibitor

FDA label, Indications wording

Brand names

Tirofiban Hydrochloride

openFDA label

Who reports

2,889 reports · 89% serious · 456 with death outcome · 38% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Tirofiban hydrochloride injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) .

FDA label, Indications and Usage

What it is

Tirofiban hydrochloride injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N- (butylsulfonyl)- O -[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate.

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 34 strongest signals

Labeled adverse reaction 5Labeled (related wording) 1Likely indication confounding 6Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 16

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.
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. 11 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Haemorrhage intracranial	181	88.6 76.9–102.1ROR 94.5 · χ² 15,413 / p <1e-300	86.8 EB05 76.7 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 56.9 · 98% clinician	no trial data cached
Angina pectoris	188	47.6 41.4–54.7ROR 50.9 · χ² 8,487 / p <1e-300	47.1 EB05 41.7 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 31.7 · ♀ 61% (drug 38%) · 99% clinician	no trial data cached
Acute respiratory failure	101	38.5 31.8–46.6ROR 39.8 · χ² 3,634 / p <1e-300	38.0 EB05 32.2 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 24.9 · 99% clinician	no trial data cached
Haemorrhage	377	26.3 23.9–28.9ROR 30.1 · χ² 9,149 / p <1e-300	26.1 EB05 24.0 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.9 · 100% clinician	no trial data cached
Cerebral haemorrhage	125	25.5 21.4–30.2ROR 26.6 · χ² 2,907 / p <1e-300	25.3 EB05 21.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 16.5 · 98% clinician	no trial data cached
Cardiogenic shock	47	24.0 18.1–31.9ROR 24.4 · χ² 1,010 / p 8e-222	23.7 EB05 18.5 · IC025 +3.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 15.5 · 98% clinician	no trial data cached
Thrombocytopenia (low platelets)	307	20.0 18.0–22.3ROR 22.3 · χ² 5,547 / p <1e-300	20.0 EB05 18.2 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.8 · 97% clinician	no trial data cached
Acute myocardial infarction	49	12.0 9.1–15.9ROR 12.2 · χ² 484 / p 1e-107	11.7 EB05 9.1 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 7.6 · 98% clinician	no trial data cached
Subarachnoid haemorrhage	16	11.4 7.0–18.6ROR 11.4 · χ² 141 / p 7e-33	10.1 EB05 6.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Gingival bleeding	20	10.6 6.9–16.5ROR 10.7 · χ² 165 / p 5e-38	9.6 EB05 6.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	no trial data cached
Petechiae	15	10.5 6.3–17.4ROR 10.5 · χ² 119 / p 5e-28	9.1 EB05 5.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Coronary artery occlusion	19	10.0 6.4–15.7ROR 10.1 · χ² 145 / p 1e-33	8.9 EB05 5.7 · IC025 +2.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 6.5	no trial data cached
Myocardial infarction (heart attack)	208	8.6 7.5–9.8ROR 9.2 · χ² 1,398 / p <1e-300	8.5 EB05 7.5 · IC025 +2.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 5.6 · 100% clinician	no trial data cached
Cardiac failure (heart failure)	88	8.0 6.5–9.8ROR 8.2 · χ² 530 / p 2e-117	7.7 EB05 6.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.2 · 99% clinician	no trial data cached
Ventricular fibrillation	12	7.8 4.4–13.8ROR 7.9 · χ² 65 / p 4e-16	6.3 EB05 3.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Haemoptysis	30	7.8 5.5–11.1ROR 7.9 · χ² 171 / p 2e-39	7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.3 · 100% clinician	no trial data cached
Haematoma	27	7.5 5.2–11.0ROR 7.6 · χ² 147 / p 5e-34	6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.7 · 96% clinician	no trial data cached
Haematuria (blood in urine)	34	7.2 5.2–10.1ROR 7.3 · χ² 175 / p 2e-40	6.7 EB05 4.9 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.3 · ♀ 14% (drug 38%)	no trial data cached
Post procedural haemorrhage	11	6.8 3.8–12.3ROR 6.9 · χ² 49 / p 1e-12	5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	no trial data cached
Upper gastrointestinal haemorrhage	15	6.5 3.9–10.7ROR 6.5 · χ² 64 / p 7e-16	5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.2	no trial data cached
Multiple organ dysfunction syndrome	23	6.0 4.0–9.0ROR 6.0 · χ² 91 / p 9e-22	5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 3.9 · 96% clinician	no trial data cached
Haematemesis (vomiting blood)	20	5.7 3.7–8.8ROR 5.7 · χ² 73 / p 6e-18	5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.8 · 95% clinician	no trial data cached
Ejection fraction decreased	12	5.6 3.2–9.8ROR 5.6 · χ² 41 / p 8e-11	4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree	Lab value / disease marker	serious PRR 4.0	no trial data cached
Shock	17	5.4 3.4–8.7ROR 5.4 · χ² 57 / p 2e-14	4.8 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 3.5	no trial data cached
Ischaemic stroke	13	5.3 3.1–9.1ROR 5.3 · χ² 41 / p 8e-11	4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 3.4	no trial data cached
Haematocrit decreased	14	5.1 3.0–8.6ROR 5.1 · χ² 42 / p 4e-11	4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree	Lab value / disease marker	serious PRR 3.7	no trial data cached
Arrhythmia	32	4.9 3.5–6.9ROR 4.9 · χ² 95 / p 9e-23	4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 3.3 · 100% clinician	no trial data cached
Ventricular tachycardia	11	4.8 2.7–8.7ROR 4.8 · χ² 30 / p 3e-8	4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.2	no trial data cached
Post procedural complication	12	4.5 2.6–8.0ROR 4.5 · χ² 30 / p 3e-8	3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2	no trial data cached
Gastrointestinal haemorrhage	42	3.6 2.7–4.9ROR 3.7 · χ² 78 / p 6e-19	3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 2.3 · 100% clinician	no trial data cached
Melaena (black stool)	10	3.3 1.8–6.1ROR 3.3 · χ² 14 / p 1e-4	2.9 EB05 1.7 · IC025 +0.5	Not in label — unassessed	serious PRR 2.0	no trial data cached
Drug administration error	14	3.3 1.9–5.5ROR 3.3 · χ² 20 / p 4e-6	3.0 EB05 1.9 · IC025 +0.7	Reporting / coding artifact	serious PRR 6.2	no trial data cached
Cerebral infarction	10	3.0 1.6–5.5ROR 3.0 · χ² 11 / p 4e-4	2.7 EB05 1.6 · IC025 +0.4	Likely indication confounding shares a disease stem with the indications wording	serious PRR 1.9	no trial data cached
Drug resistance	10	2.8 1.5–5.2ROR 2.8 · χ² 10 / p 8e-4	2.6 EB05 1.5 · IC025 +0.3	Reporting / coding artifact	serious PRR 1.2	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
Haemorrhage	377	26.3 23.9–28.9ROR 30.1 · χ² 9,149 / p <1e-300	26.1 EB05 24.0 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.9 · 100% clinician	no trial data cached
Thrombocytopenia (low platelets)	307	20.0 18.0–22.3ROR 22.3 · χ² 5,547 / p <1e-300	20.0 EB05 18.2 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.8 · 97% clinician	no trial data cached
Myocardial infarction (heart attack)	208	8.6 7.5–9.8ROR 9.2 · χ² 1,398 / p <1e-300	8.5 EB05 7.5 · IC025 +2.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 5.6 · 100% clinician	no trial data cached
Angina pectoris	188	47.6 41.4–54.7ROR 50.9 · χ² 8,487 / p <1e-300	47.1 EB05 41.7 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 31.7 · ♀ 61% (drug 38%) · 99% clinician	no trial data cached
Haemorrhage intracranial	181	88.6 76.9–102.1ROR 94.5 · χ² 15,413 / p <1e-300	86.8 EB05 76.7 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 56.9 · 98% clinician	no trial data cached
Cerebral haemorrhage	125	25.5 21.4–30.2ROR 26.6 · χ² 2,907 / p <1e-300	25.3 EB05 21.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 16.5 · 98% clinician	no trial data cached
Acute respiratory failure	101	38.5 31.8–46.6ROR 39.8 · χ² 3,634 / p <1e-300	38.0 EB05 32.2 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 24.9 · 99% clinician	no trial data cached
Cardiac failure (heart failure)	88	8.0 6.5–9.8ROR 8.2 · χ² 530 / p 2e-117	7.7 EB05 6.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.2 · 99% clinician	no trial data cached
Acute myocardial infarction	49	12.0 9.1–15.9ROR 12.2 · χ² 484 / p 1e-107	11.7 EB05 9.1 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 7.6 · 98% clinician	no trial data cached
Cardiogenic shock	47	24.0 18.1–31.9ROR 24.4 · χ² 1,010 / p 8e-222	23.7 EB05 18.5 · IC025 +3.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 15.5 · 98% clinician	no trial data cached
Gastrointestinal haemorrhage	42	3.6 2.7–4.9ROR 3.7 · χ² 78 / p 6e-19	3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 2.3 · 100% clinician	no trial data cached
Haematuria (blood in urine)	34	7.2 5.2–10.1ROR 7.3 · χ² 175 / p 2e-40	6.7 EB05 4.9 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.3 · ♀ 14% (drug 38%)	no trial data cached
Arrhythmia	32	4.9 3.5–6.9ROR 4.9 · χ² 95 / p 9e-23	4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 3.3 · 100% clinician	no trial data cached
Haemoptysis	30	7.8 5.5–11.1ROR 7.9 · χ² 171 / p 2e-39	7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.3 · 100% clinician	no trial data cached
Haematoma	27	7.5 5.2–11.0ROR 7.6 · χ² 147 / p 5e-34	6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.7 · 96% clinician	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.

Angina pectoris — n=188, PRR 47.6
Acute respiratory failure — n=101, PRR 38.5
Cerebral haemorrhage — n=125, PRR 25.5
Gingival bleeding — n=20, PRR 10.6
Cardiac failure — n=88, PRR 8.0
Haematoma — n=27, PRR 7.5
Multiple organ dysfunction syndrome — n=23, PRR 6.0
Arrhythmia — n=32, PRR 4.9
Gastrointestinal haemorrhage — n=42, PRR 3.6

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 Tirofiban?

In FDA FAERS, the most frequently co-reported reaction terms for Tirofiban are haemorrhage, thrombocytopenia, myocardial infarction, angina pectoris, haemorrhage intracranial, cerebral 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 Tirofiban have an FDA boxed warning?

No. The FDA label retrieved for Tirofiban has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Tirofiban 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 fa3ac570-f9f6-474c-a920-bd0cf03045ac, effective 20210519; matched on openfda.generic_name.exact:"TIROFIBAN")
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, field patient.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.