Drug · FAERS side-effect profile with label screen
Verapamil side effects: what 4,242 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Verapamil Hydrochloride (Verapamil Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,242 reports · 91% serious · 948 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Verapamil Hydrochloride Injection, USP is indicated for the following: • Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes).
FDA label, Indications and Usage
What it is
DESCRIPTION Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection.
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 2Labeled (related wording) 1Likely indication confounding 6Reporting / coding artifact 2Outcome field, not a reaction 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.
- 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.
- 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. 209 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 |
|---|---|---|---|---|---|---|
| Ocular discomfort | 148 | 68.3 58.2–80.1ROR 70.7 · χ² 9,618 / p <1e-300 | 66.8 EB05 58.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=147 · 91% clinician | no trial data cached |
| Generalised oedema | 129 | 52.3 44.1–62.1ROR 53.9 · χ² 6,380 / p <1e-300 | 51.4 EB05 44.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 36.4 · 94% clinician | no trial data cached |
| Head discomfort | 155 | 43.9 37.6–51.3ROR 45.5 · χ² 6,401 / p <1e-300 | 43.3 EB05 37.9 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 48.4 | no trial data cached |
| Cardiogenic shock | 111 | 38.8 32.2–46.6ROR 39.8 · χ² 4,016 / p <1e-300 | 38.2 EB05 32.6 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.3 · 97% clinician | no trial data cached |
| Altered state of consciousness | 167 | 38.6 33.3–44.8ROR 40.1 · χ² 6,039 / p <1e-300 | 38.2 EB05 33.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · ♀ 27% (drug 59%) · 93% clinician | no trial data cached |
| Photophobia (light sensitivity) | 125 | 33.3 28.0–39.6ROR 34.3 · χ² 3,863 / p <1e-300 | 33.0 EB05 28.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 33.2 · 92% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 158 | 30.9 26.5–36.0ROR 32.1 · χ² 4,521 / p <1e-300 | 30.6 EB05 26.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 · 92% clinician | no trial data cached |
| Ascites | 161 | 27.2 23.4–31.7ROR 28.2 · χ² 4,021 / p <1e-300 | 27.0 EB05 23.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 | no trial data cached |
| Presyncope (near-fainting) | 132 | 27.1 22.9–32.1ROR 28.0 · χ² 3,279 / p <1e-300 | 26.9 EB05 23.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 21.9 · 93% clinician | no trial data cached |
| Cardio-respiratory arrest | 196 | 23.1 20.2–26.5ROR 24.2 · χ² 4,116 / p <1e-300 | 23.0 EB05 20.4 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 14.6 · 93% clinician | no trial data cached |
| Diplopia (double vision) | 119 | 22.8 19.0–27.2ROR 23.4 · χ² 2,444 / p <1e-300 | 22.6 EB05 19.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 19.6 · 93% clinician | no trial data cached |
| Coma | 202 | 21.0 18.4–24.1ROR 22.0 · χ² 3,827 / p <1e-300 | 20.9 EB05 18.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · ♀ 35% (drug 59%) · 92% clinician | no trial data cached |
| Haematuria (blood in urine) | 143 | 20.7 17.6–24.3ROR 21.4 · χ² 2,654 / p <1e-300 | 20.6 EB05 17.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 · 94% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 213 | 19.9 17.5–22.7ROR 20.9 · χ² 3,798 / p <1e-300 | 19.8 EB05 17.7 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.9 · 95% clinician | no trial data cached |
| Blindness | 153 | 18.6 16.0–21.8ROR 19.3 · χ² 2,533 / p <1e-300 | 18.5 EB05 16.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · 91% clinician | no trial data cached |
| Shock | 75 | 16.3 13.0–20.4ROR 16.6 · χ² 1,060 / p 1e-232 | 16.2 EB05 13.3 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · ♀ 35% (drug 59%) · 92% clinician | no trial data cached |
| Completed suicide (death by suicide) | 236 | 13.9 12.3–15.7ROR 14.7 · χ² 2,817 / p <1e-300 | 13.8 EB05 12.4 · IC025 +3.5 3/3 methods agree | Outcome field, not a reaction | serious PRR 8.8 · 99% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 129 | 13.9 11.7–16.5ROR 14.3 · χ² 1,530 / p <1e-300 | 13.8 EB05 11.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · 93% clinician | no trial data cached |
| Eye pain | 149 | 13.4 11.4–15.7ROR 13.8 · χ² 1,693 / p <1e-300 | 13.3 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 | no trial data cached |
| Acute respiratory distress syndrome | 46 | 12.9 9.7–17.2ROR 13.0 · χ² 492 / p 3e-109 | 12.6 EB05 9.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 95% clinician | no trial data cached |
| Sinus bradycardia | 25 | 12.8 8.6–18.9ROR 12.9 · χ² 260 / p 1e-58 | 12.2 EB05 8.3 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.3 · 100% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 228 | 12.7 11.2–14.4ROR 13.4 · χ² 2,454 / p <1e-300 | 12.6 EB05 11.3 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.8 | no trial data cached |
| Supraventricular tachycardia | 22 | 11.4 7.5–17.3ROR 11.5 · χ² 198 / p 3e-45 | 10.5 EB05 7.0 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.2 | no trial data cached |
| Ventricular extrasystoles | 23 | 11.0 7.3–16.5ROR 11.0 · χ² 198 / p 3e-45 | 10.1 EB05 6.8 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.7 | no trial data cached |
| Ischaemic stroke | 39 | 10.8 7.9–14.8ROR 10.9 · χ² 337 / p 1e-75 | 10.3 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 25% (drug 59%) · 95% clinician | no trial data cached |
| Drug interaction | 315 | 9.8 8.8–10.9ROR 10.5 · χ² 2,505 / p <1e-300 | 9.8 EB05 8.9 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · 91% clinician | no trial data cached |
| Ileus | 24 | 9.7 6.5–14.4ROR 9.7 · χ² 178 / p 8e-41 | 8.8 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 17% (drug 59%) | no trial data cached |
| Metabolic acidosis | 60 | 9.4 7.3–12.1ROR 9.5 · χ² 441 / p 3e-98 | 9.0 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 100% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 62 | 8.8 6.9–11.3ROR 8.9 · χ² 421 / p 9e-94 | 8.4 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 96% clinician | no trial data cached |
| Atelectasis | 17 | 8.7 5.4–14.0ROR 8.7 · χ² 108 / p 1e-25 | 7.5 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Sepsis (blood infection) | 188 | 8.3 7.3–9.6ROR 8.7 · χ² 1,212 / p 8e-266 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Toxic skin eruption | 17 | 8.3 5.2–13.4ROR 8.4 · χ² 102 / p 2e-24 | 7.2 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Extrapyramidal disorder | 42 | 8.3 6.1–11.2ROR 8.4 · χ² 262 / p 3e-59 | 7.8 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 95% (drug 59%) · 95% clinician | no trial data cached |
| Quality of life decreased | 22 | 8.1 5.3–12.3ROR 8.1 · χ² 130 / p 2e-30 | 7.2 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 77% consumer | no trial data cached |
| Cerebral infarction | 40 | 8.1 5.9–11.0ROR 8.2 · χ² 242 / p 8e-55 | 7.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 34% (drug 59%) | no trial data cached |
| Intentional overdose | 103 | 8.0 6.6–9.7ROR 8.2 · χ² 625 / p 3e-138 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 99% clinician | no trial data cached |
| Mitral valve incompetence | 18 | 7.9 5.0–12.5ROR 7.9 · χ² 101 / p 4e-24 | 6.8 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Hypomagnesaemia | 22 | 7.9 5.2–11.9ROR 7.9 · χ² 125 / p 3e-29 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 95% clinician | no trial data cached |
| Oesophagitis | 17 | 7.7 4.8–12.4ROR 7.7 · χ² 92 / p 4e-22 | 6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Syncope (fainting) | 155 | 7.7 6.6–8.9ROR 7.9 · χ² 895 / p 7e-197 | 7.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 353 | 3.1 2.8–3.4ROR 3.3 · χ² 509 / p 4e-113 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Drug interaction | 315 | 9.8 8.8–10.9ROR 10.5 · χ² 2,505 / p <1e-300 | 9.8 EB05 8.9 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · 91% clinician | no trial data cached |
| Dizziness | 289 | 2.9 2.6–3.2ROR 3.0 · χ² 359 / p 2e-80 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Hypotension (low blood pressure) | 287 | 7.1 6.3–7.9ROR 7.5 · χ² 1,509 / p <1e-300 | 7.0 EB05 6.4 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.1 | no trial data cached |
| Abdominal pain | 242 | 5.2 4.6–5.8ROR 5.4 · χ² 814 / p 3e-179 | 5.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Cough | 241 | 4.3 3.8–4.8ROR 4.5 · χ² 606 / p 4e-134 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Completed suicide (death by suicide) | 236 | 13.9 12.3–15.7ROR 14.7 · χ² 2,817 / p <1e-300 | 13.8 EB05 12.4 · IC025 +3.5 3/3 methods agree | Outcome field, not a reaction | serious PRR 8.8 · 99% clinician | no trial data cached |
| Fall | 234 | 3.5 3.1–3.9ROR 3.6 · χ² 418 / p 4e-93 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Asthenia (weakness) | 229 | 3.0 2.7–3.4ROR 3.1 · χ² 311 / p 6e-70 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Tachycardia (fast heart rate) | 228 | 12.7 11.2–14.4ROR 13.4 · χ² 2,454 / p <1e-300 | 12.6 EB05 11.3 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.8 | no trial data cached |
| Pruritus (itching) | 224 | 2.9 2.6–3.3ROR 3.0 · χ² 288 / p 6e-65 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Malaise (feeling unwell) | 223 | 2.5 2.2–2.9ROR 2.6 · χ² 205 / p 8e-47 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Bradycardia (slow heart rate) | 213 | 19.9 17.5–22.7ROR 20.9 · χ² 3,798 / p <1e-300 | 19.8 EB05 17.7 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.9 · 95% clinician | no trial data cached |
| Arthralgia (joint pain) | 207 | 2.5 2.2–2.8ROR 2.5 · χ² 183 / p 5e-42 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Blood pressure increased | 202 | 6.5 5.7–7.5ROR 6.8 · χ² 945 / p 7e-208 | 6.4 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | 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.
- Ocular discomfort — n=148, PRR 68.3
- Generalised oedema — n=129, PRR 52.3
- Altered state of consciousness — n=167, PRR 38.6
- Photophobia — n=125, PRR 33.3
- Haematemesis — n=158, PRR 30.9
- Ascites — n=161, PRR 27.2
- Presyncope — n=132, PRR 27.1
- Diplopia — n=119, PRR 22.8
- Coma — n=202, PRR 21.0
- Haematuria — n=143, PRR 20.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Verapamil (non-dihydropyridine CCBs) ↔ Bradycardia / AV block.
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 Verapamil?
In FDA FAERS, the most frequently co-reported reaction terms for Verapamil are dyspnoea, dizziness, hypotension, abdominal pain, cough, fall. 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 Verapamil have an FDA boxed warning?
No. The FDA label retrieved for Verapamil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Verapamil 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 03c5daf8-5399-4d89-a747-9a9d7667b6e4, effective 20200325; matched on
openfda.generic_name.exact:"VERAPAMIL HYDROCHLORIDE") - 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, 249 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.