Drug · FAERS side-effect profile with label screen
Dipyridamole side effects: what 3,743 FDA adverse event reports show
Drug class
Platelet Aggregation Inhibitor
FDA label (Established Pharmacologic Class)
Who reports
3,743 reports · 93% serious · 461 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dipyridamole Injection is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately. In a study of about 1100 patients who underwent coronar.
FDA label, Indications and Usage
What it is
DESCRIPTION Dipyridamole is a coronary vasodilator described as 2,2',2'',2'''-[(4,8 Dipiperidinopyrimido[ 5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol.
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 4Labeled (related wording) 3Reporting / coding artifact 1Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 30
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 154 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 |
|---|---|---|---|---|---|---|
| Blood calcium decreased | 445 | 230.3 210.6–251.8ROR 261.2 · χ² 97,357 / p <1e-300 | 219.0 EB05 202.5 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious PRR 170.6 · ♀ 100% (drug 54%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 467 | 154.2 141.5–168.1ROR 176.0 · χ² 69,054 / p <1e-300 | 149.1 EB05 138.1 · IC025 +6.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 105.3 · ♀ 99% (drug 54%) | no trial data cached |
| Sedation | 440 | 96.3 88.1–105.2ROR 109.0 · χ² 40,723 / p <1e-300 | 94.2 EB05 87.1 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 80.5 · ♀ 100% (drug 54%) | no trial data cached |
| Depressed level of consciousness | 478 | 68.7 63.2–74.8ROR 78.6 · χ² 31,499 / p <1e-300 | 67.7 EB05 62.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 43.0 · ♀ 98% (drug 54%) | no trial data cached |
| Cognitive disorder | 504 | 61.4 56.6–66.6ROR 70.8 · χ² 29,626 / p <1e-300 | 60.6 EB05 56.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 52.5 · ♀ 96% (drug 54%) | no trial data cached |
| Mobility decreased | 443 | 34.9 32.0–38.1ROR 39.4 · χ² 14,508 / p <1e-300 | 34.6 EB05 32.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 31.6 · ♀ 99% (drug 54%) | no trial data cached |
| Balance disorder | 467 | 30.4 27.9–33.1ROR 34.6 · χ² 13,232 / p <1e-300 | 30.2 EB05 28.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 29.9 · ♀ 98% (drug 54%) | no trial data cached |
| Bladder disorder | 37 | 20.9 15.2–28.8ROR 21.1 · χ² 680 / p 4e-150 | 20.6 EB05 15.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 97% (drug 54%) | no trial data cached |
| Haemorrhage intracranial | 47 | 17.6 13.3–23.4ROR 17.8 · χ² 718 / p 2e-158 | 17.4 EB05 13.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · ♀ 19% (drug 54%) | no trial data cached |
| Hypotension (low blood pressure) | 536 | 15.0 13.9–16.3ROR 17.4 · χ² 7,061 / p <1e-300 | 15.0 EB05 14.0 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 · ♀ 85% (drug 54%) | no trial data cached |
| Ischaemic stroke | 46 | 14.5 10.8–19.3ROR 14.6 · χ² 562 / p 1e-124 | 14.2 EB05 11.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 100% clinician | no trial data cached |
| Circulatory collapse | 43 | 14.1 10.5–19.0ROR 14.3 · χ² 511 / p 2e-113 | 13.9 EB05 10.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 76% (drug 54%) | no trial data cached |
| Toxicity to various agents | 401 | 13.4 12.2–14.7ROR 14.9 · χ² 4,625 / p <1e-300 | 13.4 EB05 12.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 98% (drug 54%) | no trial data cached |
| Constipation | 470 | 12.2 11.2–13.3ROR 13.8 · χ² 4,862 / p <1e-300 | 12.2 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · ♀ 98% (drug 54%) | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 69 | 11.4 9.1–14.5ROR 11.6 · χ² 647 / p 6e-143 | 11.2 EB05 9.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Peripheral coldness | 26 | 10.6 7.2–15.5ROR 10.7 · χ² 216 / p 3e-49 | 9.8 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 83% (drug 54%) | no trial data cached |
| Cerebral haemorrhage | 64 | 10.0 7.9–12.8ROR 10.2 · χ² 512 / p 9e-114 | 9.7 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 23% (drug 54%) · 100% clinician | no trial data cached |
| Subarachnoid haemorrhage | 18 | 9.9 6.2–15.7ROR 9.9 · χ² 135 / p 2e-31 | 8.7 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Subdural haematoma | 25 | 9.8 6.6–14.4ROR 9.8 · χ² 188 / p 4e-43 | 8.9 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 96% clinician | no trial data cached |
| Fall | 550 | 9.3 8.6–10.0ROR 10.7 · χ² 4,119 / p <1e-300 | 9.2 EB05 8.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 95% (drug 54%) | no trial data cached |
| Eyelid ptosis | 16 | 8.8 5.4–14.4ROR 8.9 · χ² 103 / p 1e-24 | 7.5 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Cerebral infarction | 38 | 8.7 6.4–12.0ROR 8.8 · χ² 252 / p 5e-57 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 | no trial data cached |
| Upper gastrointestinal haemorrhage | 26 | 8.6 5.9–12.7ROR 8.7 · χ² 168 / p 9e-39 | 7.8 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Tubulointerstitial nephritis | 28 | 8.4 5.8–12.1ROR 8.4 · χ² 175 / p 3e-40 | 7.6 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Oesophagitis | 16 | 8.2 5.0–13.4ROR 8.2 · χ² 94 / p 1e-22 | 7.0 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Multi-organ failure | 25 | 8.0 5.4–11.8ROR 8.0 · χ² 146 / p 6e-34 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Dementia | 39 | 7.9 5.8–10.7ROR 7.9 · χ² 227 / p 2e-51 | 7.3 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 91% (drug 54%) | no trial data cached |
| Drug eruption | 22 | 7.0 4.6–10.6ROR 7.0 · χ² 107 / p 2e-25 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 90% clinician | no trial data cached |
| Drug interaction | 197 | 7.0 6.1–8.0ROR 7.3 · χ² 1,007 / p 2e-221 | 6.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 92% clinician | no trial data cached |
| Hemiparesis | 21 | 6.9 4.5–10.6ROR 6.9 · χ² 100 / p 6e-24 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 33% (drug 54%) | no trial data cached |
| Myocardial ischaemia | 14 | 6.8 4.1–11.6ROR 6.9 · χ² 64 / p 6e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Angina pectoris | 35 | 6.8 4.9–9.5ROR 6.9 · χ² 168 / p 1e-38 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 97% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 48 | 6.5 4.9–8.6ROR 6.5 · χ² 217 / p 2e-49 | 6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 · 100% clinician | no trial data cached |
| Bone disorder | 21 | 6.4 4.2–9.8ROR 6.4 · χ² 91 / p 9e-22 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Sudden death | 12 | 6.3 3.6–11.1ROR 6.3 · χ² 48 / p 2e-12 | 5.2 EB05 3.2 · IC025 +1.4 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.9 | no trial data cached |
| Coordination abnormal | 15 | 6.0 3.6–9.9ROR 6.0 · χ² 57 / p 2e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 | no trial data cached |
| Haematemesis (vomiting blood) | 27 | 6.0 4.1–8.7ROR 6.0 · χ² 107 / p 3e-25 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · ♀ 21% (drug 54%) · 100% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 16 | 6.0 3.7–9.7ROR 6.0 · χ² 61 / p 3e-15 | 5.1 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Melaena (black stool) | 22 | 5.6 3.7–8.5ROR 5.6 · χ² 78 / p 4e-19 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 100% clinician | no trial data cached |
| Anorexia | 13 | 5.6 3.2–9.6ROR 5.6 · χ² 44 / p 1e-11 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | 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 |
|---|---|---|---|---|---|---|
| Fall | 550 | 9.3 8.6–10.0ROR 10.7 · χ² 4,119 / p <1e-300 | 9.2 EB05 8.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 95% (drug 54%) | no trial data cached |
| Hypotension (low blood pressure) | 536 | 15.0 13.9–16.3ROR 17.4 · χ² 7,061 / p <1e-300 | 15.0 EB05 14.0 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 · ♀ 85% (drug 54%) | no trial data cached |
| Pain | 521 | 4.8 4.4–5.1ROR 5.4 · χ² 1,584 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · ♀ 93% (drug 54%) | no trial data cached |
| Cognitive disorder | 504 | 61.4 56.6–66.6ROR 70.8 · χ² 29,626 / p <1e-300 | 60.6 EB05 56.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 52.5 · ♀ 96% (drug 54%) | no trial data cached |
| Depressed level of consciousness | 478 | 68.7 63.2–74.8ROR 78.6 · χ² 31,499 / p <1e-300 | 67.7 EB05 62.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 43.0 · ♀ 98% (drug 54%) | no trial data cached |
| Constipation | 470 | 12.2 11.2–13.3ROR 13.8 · χ² 4,862 / p <1e-300 | 12.2 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · ♀ 98% (drug 54%) | no trial data cached |
| Balance disorder | 467 | 30.4 27.9–33.1ROR 34.6 · χ² 13,232 / p <1e-300 | 30.2 EB05 28.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 29.9 · ♀ 98% (drug 54%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 467 | 154.2 141.5–168.1ROR 176.0 · χ² 69,054 / p <1e-300 | 149.1 EB05 138.1 · IC025 +6.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 105.3 · ♀ 99% (drug 54%) | no trial data cached |
| Blood calcium decreased | 445 | 230.3 210.6–251.8ROR 261.2 · χ² 97,357 / p <1e-300 | 219.0 EB05 202.5 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious PRR 170.6 · ♀ 100% (drug 54%) | no trial data cached |
| Mobility decreased | 443 | 34.9 32.0–38.1ROR 39.4 · χ² 14,508 / p <1e-300 | 34.6 EB05 32.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 31.6 · ♀ 99% (drug 54%) | no trial data cached |
| Sedation | 440 | 96.3 88.1–105.2ROR 109.0 · χ² 40,723 / p <1e-300 | 94.2 EB05 87.1 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 80.5 · ♀ 100% (drug 54%) | no trial data cached |
| Toxicity to various agents | 401 | 13.4 12.2–14.7ROR 14.9 · χ² 4,625 / p <1e-300 | 13.4 EB05 12.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 98% (drug 54%) | no trial data cached |
| Drug interaction | 197 | 7.0 6.1–8.0ROR 7.3 · χ² 1,007 / p 2e-221 | 6.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 92% clinician | no trial data cached |
| Cerebrovascular accident (stroke) | 130 | 4.3 3.6–5.1ROR 4.4 · χ² 327 / p 2e-73 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Product use in unapproved indication | 112 | 2.6 2.1–3.1ROR 2.6 · χ² 107 / p 2e-25 | 2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 · ♀ 88% (drug 54%) · 92% 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.
- Sedation — n=440, PRR 96.3
- Depressed level of consciousness — n=478, PRR 68.7
- Cognitive disorder — n=504, PRR 61.4
- Mobility decreased — n=443, PRR 34.9
- Balance disorder — n=467, PRR 30.4
- Bladder disorder — n=37, PRR 20.9
- Haemorrhage intracranial — n=47, PRR 17.6
- Ischaemic stroke — n=46, PRR 14.5
- Circulatory collapse — n=43, PRR 14.1
- Toxicity to various agents — n=401, PRR 13.4
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 Dipyridamole?
In FDA FAERS, the most frequently co-reported reaction terms for Dipyridamole are fall, hypotension, pain, cognitive disorder, depressed level of consciousness, constipation. 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 Dipyridamole have an FDA boxed warning?
No. The FDA label retrieved for Dipyridamole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dipyridamole 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 6093dcd9-82d2-414f-8507-eda22c14f626, effective 20260520; matched on
openfda.generic_name.exact:"DIPYRIDAMOLE") - 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, 194 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.