Drug · FAERS side-effect profile with label screen
Carvedilol side effects: what 2,969 FDA adverse event reports show
Drug class
alpha-Adrenergic Blocker, beta-Adrenergic Blocker
FDA label (Established Pharmacologic Class) · compare the class
Who reports
2,969 reports · 38% serious · 148 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients( 1.2 ) hypertension( .
FDA label, Indications and Usage
What it is
Carvedilol is a nonselective β-adrenergic blocking agent with α 1 -blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mi.
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 7Labeled (related wording) 9Likely indication confounding 4Reporting / coding artifact 5Lab value / disease marker 1Not in label — unassessed 14
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. 56 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 |
|---|---|---|---|---|---|---|
| Heart rate decreased | 53 | 10.6 8.1–13.9ROR 10.8 · χ² 452 / p 1e-100 | 10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · 91% consumer | no trial data cached |
| Ejection fraction decreased | 23 | 10.4 7.0–15.7ROR 10.5 · χ² 187 / p 7e-43 | 9.6 EB05 6.4 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.7 · 91% consumer | no trial data cached |
| Heart rate irregular | 31 | 9.6 6.8–13.7ROR 9.7 · χ² 232 / p 1e-52 | 9.0 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 87% consumer | no trial data cached |
| Peripheral coldness | 18 | 9.2 5.8–14.6ROR 9.3 · χ² 124 / p 4e-29 | 8.1 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Blood pressure fluctuation | 31 | 9.1 6.4–12.9ROR 9.2 · χ² 216 / p 4e-49 | 8.4 EB05 6.1 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 · 84% consumer | no trial data cached |
| Ventricular extrasystoles | 13 | 8.8 5.1–15.2ROR 8.9 · χ² 83 / p 5e-20 | 7.3 EB05 4.3 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.6 | no trial data cached |
| Cardiomyopathy | 16 | 7.6 4.7–12.5ROR 7.7 · χ² 86 / p 1e-20 | 6.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.7 | no trial data cached |
| Blood pressure decreased | 66 | 7.0 5.5–8.9ROR 7.2 · χ² 336 / p 2e-75 | 6.7 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 · 86% consumer | no trial data cached |
| Sluggishness | 10 | 7.0 3.7–12.9ROR 7.0 · χ² 45 / p 9e-12 | 5.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Blood pressure increased | 139 | 6.4 5.5–7.5ROR 6.7 · χ² 634 / p 4e-140 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 · 84% consumer | no trial data cached |
| Cardiac failure congestive | 63 | 5.5 4.3–7.0ROR 5.6 · χ² 228 / p 1e-51 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 | no trial data cached |
| Drug dispensing error | 12 | 5.5 3.1–9.6ROR 5.5 · χ² 40 / p 2e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Arrhythmia | 35 | 5.2 3.7–7.2ROR 5.3 · χ² 115 / p 4e-27 | 4.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 88% consumer | no trial data cached |
| Product substitution issue | 36 | 4.4 3.2–6.1ROR 4.5 · χ² 92 / p 4e-22 | 4.2 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · ♀ 79% (drug 55%) · 97% consumer | no trial data cached |
| Dizziness | 309 | 4.4 3.9–4.9ROR 4.8 · χ² 823 / p 2e-181 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 89% consumer | no trial data cached |
| Blood potassium increased | 10 | 4.4 2.3–8.1ROR 4.4 · χ² 23 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Hypotension (low blood pressure) | 121 | 4.3 3.6–5.1ROR 4.4 · χ² 302 / p 5e-68 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 81% consumer | no trial data cached |
| Ventricular tachycardia | 10 | 4.3 2.3–7.9ROR 4.3 · χ² 22 / p 1e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
| Angina pectoris | 17 | 4.2 2.6–6.7ROR 4.2 · χ² 38 / p 4e-10 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Eructation (belching) | 11 | 4.1 2.3–7.4ROR 4.1 · χ² 23 / p 1e-6 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Drug administration error | 18 | 4.1 2.6–6.5ROR 4.1 · χ² 39 / p 2e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Pharmaceutical product complaint | 15 | 4.0 2.4–6.7ROR 4.0 · χ² 31 / p 1e-8 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.0 | no trial data cached |
| Palpitations (pounding heartbeat) | 66 | 4.0 3.1–5.1ROR 4.1 · χ² 145 / p 9e-34 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 88% consumer | no trial data cached |
| Ill-defined disorder | 34 | 4.0 2.8–5.5ROR 4.0 · χ² 72 / p 1e-17 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 91% consumer | no trial data cached |
| Hypersomnia | 16 | 3.9 2.4–6.4ROR 4.0 · χ² 32 / p 6e-9 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Abasia | 14 | 3.9 2.3–6.7ROR 4.0 · χ² 28 / p 6e-8 | 3.5 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Coronary artery disease | 17 | 3.9 2.5–6.3ROR 4.0 · χ² 34 / p 2e-9 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Acute myocardial infarction | 16 | 3.8 2.3–6.2ROR 3.8 · χ² 31 / p 2e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Product availability issue | 12 | 3.8 2.1–6.7ROR 3.8 · χ² 22 / p 1e-6 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Heart rate increased | 52 | 3.7 2.8–4.9ROR 3.8 · χ² 101 / p 5e-24 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 · 84% consumer | no trial data cached |
| Disability | 10 | 3.6 1.9–6.6ROR 3.6 · χ² 16 / p 3e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Pollakiuria (frequent urination) | 19 | 3.2 2.1–5.0ROR 3.2 · χ² 27 / p 1e-7 | 3.0 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Feeling hot | 28 | 3.2 2.2–4.7ROR 3.2 · χ² 41 / p 8e-11 | 3.1 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.5 · 91% consumer | no trial data cached |
| Cardiac disorder | 41 | 3.1 2.3–4.2ROR 3.1 · χ² 56 / p 4e-14 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 · 72% consumer | no trial data cached |
| Myocardial infarction (heart attack) | 74 | 3.0 2.4–3.7ROR 3.0 · χ² 96 / p 7e-23 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.6 | no trial data cached |
| Fluid retention | 21 | 2.9 1.9–4.5ROR 2.9 · χ² 25 / p 3e-7 | 2.8 EB05 1.9 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 3.5 · ♀ 33% (drug 55%) | no trial data cached |
| Hip fracture | 13 | 2.9 1.7–4.9ROR 2.9 · χ² 14 / p 9e-5 | 2.7 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Nightmare | 13 | 2.6 1.5–4.5ROR 2.6 · χ² 12 / p 3e-4 | 2.5 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Gastric disorder | 13 | 2.6 1.5–4.5ROR 2.6 · χ² 12 / p 3e-4 | 2.5 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Product quality issue | 50 | 2.6 2.0–3.4ROR 2.6 · χ² 49 / p 1e-12 | 2.6 EB05 2.0 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 88% consumer | 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 |
|---|---|---|---|---|---|---|
| Dizziness | 309 | 4.4 3.9–4.9ROR 4.8 · χ² 823 / p 2e-181 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 89% consumer | no trial data cached |
| Blood pressure increased | 139 | 6.4 5.5–7.5ROR 6.7 · χ² 634 / p 4e-140 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 · 84% consumer | no trial data cached |
| Hypotension (low blood pressure) | 121 | 4.3 3.6–5.1ROR 4.4 · χ² 302 / p 5e-68 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 81% consumer | no trial data cached |
| Myocardial infarction (heart attack) | 74 | 3.0 2.4–3.7ROR 3.0 · χ² 96 / p 7e-23 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.6 | no trial data cached |
| Palpitations (pounding heartbeat) | 66 | 4.0 3.1–5.1ROR 4.1 · χ² 145 / p 9e-34 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 88% consumer | no trial data cached |
| Blood pressure decreased | 66 | 7.0 5.5–8.9ROR 7.2 · χ² 336 / p 2e-75 | 6.7 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 · 86% consumer | no trial data cached |
| Cardiac failure congestive | 63 | 5.5 4.3–7.0ROR 5.6 · χ² 228 / p 1e-51 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 | no trial data cached |
| Cerebrovascular accident (stroke) | 53 | 2.2 1.7–2.9ROR 2.2 · χ² 34 / p 3e-9 | 2.2 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 3.4 · 73% consumer | no trial data cached |
| Heart rate decreased | 53 | 10.6 8.1–13.9ROR 10.8 · χ² 452 / p 1e-100 | 10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 · 91% consumer | no trial data cached |
| Heart rate increased | 52 | 3.7 2.8–4.9ROR 3.8 · χ² 101 / p 5e-24 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 · 84% consumer | no trial data cached |
| Drug dose omission | 50 | 2.1 1.6–2.8ROR 2.1 · χ² 28 / p 6e-8 | 2.1 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 3.9 · 94% consumer | no trial data cached |
| Product quality issue | 50 | 2.6 2.0–3.4ROR 2.6 · χ² 49 / p 1e-12 | 2.6 EB05 2.0 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 88% consumer | no trial data cached |
| Blood glucose increased | 44 | 1.6 1.2–2.2ROR 1.7 · χ² 11 / p 6e-4 | 1.6 EB05 1.3 · IC025 +0.2 | Labeled (related wording) related wording | serious PRR 2.1 · 86% consumer | no trial data cached |
| Cardiac disorder | 41 | 3.1 2.3–4.2ROR 3.1 · χ² 56 / p 4e-14 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 · 72% consumer | no trial data cached |
| Product substitution issue | 36 | 4.4 3.2–6.1ROR 4.5 · χ² 92 / p 4e-22 | 4.2 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · ♀ 79% (drug 55%) · 97% consumer | 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.
- Heart rate irregular — n=31, PRR 9.6
- Palpitations — n=66, PRR 4.0
- Ill-defined disorder — n=34, PRR 4.0
- Feeling hot — n=28, PRR 3.2
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 Carvedilol?
In FDA FAERS, the most frequently co-reported reaction terms for Carvedilol are dizziness, blood pressure increased, hypotension, myocardial infarction, palpitations, blood pressure decreased. 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 Carvedilol have an FDA boxed warning?
No. The FDA label retrieved for Carvedilol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Carvedilol 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 010290af-81f4-0037-e063-6394a90a4638, effective 20260511; matched on
openfda.generic_name.exact:"CARVEDILOL") - 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, 96 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.