Labetalol Hydrochloride side effects: what 1,940 FDA adverse event reports show
Brand names
Labetalol Hydrochloride
Who reports
1,940 reports · 69% serious · 179 with death outcome · 66% female
Used for
Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
What it is
DESCRIPTION Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1 -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.
Boxed warning
None in the current label
Causality screen of the 26 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.
- 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. 32 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 |
|---|---|---|---|---|---|---|
| Premature delivery | 77 | 52.1 41.8–64.9ROR 54.2 · χ² 3,793 / p <1e-300 | 51.2 EB05 42.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 44.0 · ♀ 95% (drug 66%) | no trial data cached |
| Premature baby | 142 | 50.9 43.4–59.7ROR 54.8 · χ² 6,876 / p <1e-300 | 50.4 EB05 43.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 42.7 · ♀ 30% (drug 66%) | no trial data cached |
| Caesarean section | 33 | 30.3 21.6–42.5ROR 30.8 · χ² 904 / p 6e-199 | 29.8 EB05 22.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 | no trial data cached |
| Maternal exposure during pregnancy | 179 | 21.9 19.1–25.2ROR 24.0 · χ² 3,559 / p <1e-300 | 21.8 EB05 19.3 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 21.5 · ♀ 91% (drug 66%) | no trial data cached |
| Foetal exposure during pregnancy | 138 | 18.3 15.6–21.5ROR 19.7 · χ² 2,249 / p <1e-300 | 18.3 EB05 15.8 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 · ♀ 26% (drug 66%) | no trial data cached |
| Diabetes mellitus inadequate control | 28 | 17.1 11.8–24.7ROR 17.3 · χ² 407 / p 8e-91 | 16.8 EB05 12.0 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.8 · ♀ 89% (drug 66%) | no trial data cached |
| Exposure during pregnancy | 86 | 14.9 12.1–18.3ROR 15.6 · χ² 1,105 / p 1e-242 | 14.8 EB05 12.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 15.3 · ♀ 99% (drug 66%) | no trial data cached |
| Pregnancy | 23 | 12.3 8.2–18.4ROR 12.4 · χ² 227 / p 2e-51 | 11.6 EB05 7.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · ♀ 95% (drug 66%) | no trial data cached |
| Cardiomegaly | 11 | 9.6 5.3–17.2ROR 9.6 · χ² 76 / p 1e-18 | 7.7 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| End stage renal disease | 16 | 9.4 5.7–15.3ROR 9.4 · χ² 111 / p 2e-26 | 8.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Cardiogenic shock | 10 | 7.6 4.1–14.0ROR 7.6 · χ² 51 / p 6e-13 | 5.9 EB05 3.4 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Drug-induced liver injury | 20 | 7.0 4.5–10.8ROR 7.1 · χ² 97 / p 4e-23 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 100% clinician | no trial data cached |
| Frequent bowel movements | 16 | 6.4 3.9–10.4ROR 6.5 · χ² 68 / p 9e-17 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Medication error | 33 | 6.4 4.6–9.0ROR 6.5 · χ² 146 / p 8e-34 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · ♀ 88% (drug 66%) · 94% clinician | no trial data cached |
| Transaminases increased | 13 | 6.3 3.7–10.8ROR 6.3 · χ² 53 / p 2e-13 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Hyperkalaemia (high potassium) | 20 | 6.2 4.0–9.6ROR 6.2 · χ² 82 / p 8e-20 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Depressed mood | 30 | 6.1 4.3–8.8ROR 6.2 · χ² 124 / p 4e-29 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 93% (drug 66%) | no trial data cached |
| Cognitive disorder | 25 | 5.8 3.9–8.6ROR 5.9 · χ² 95 / p 1e-22 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 96% (drug 66%) | no trial data cached |
| Treatment noncompliance | 29 | 5.8 4.0–8.3ROR 5.8 · χ² 109 / p 7e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · ♀ 93% (drug 66%) | no trial data cached |
| Drug exposure during pregnancy | 17 | 5.3 3.3–8.5ROR 5.3 · χ² 55 / p 5e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Pulmonary oedema | 22 | 5.3 3.5–8.0ROR 5.3 · χ² 72 / p 9e-18 | 4.8 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Completed suicide (death by suicide) | 41 | 5.3 3.9–7.1ROR 5.3 · χ² 137 / p 5e-32 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.4 · 100% clinician | no trial data cached |
| Amnesia (memory loss) | 31 | 5.1 3.6–7.3ROR 5.2 · χ² 99 / p 1e-23 | 4.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 87% (drug 66%) | no trial data cached |
| Heart rate decreased | 16 | 4.9 3.0–8.0ROR 4.9 · χ² 46 / p 7e-12 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Coronary artery disease | 12 | 4.2 2.4–7.5ROR 4.3 · χ² 27 / p 1e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Abortion spontaneous | 11 | 2.9 1.6–5.3ROR 3.0 · χ² 12 / p 2e-4 | 2.7 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.5 | 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 |
|---|---|---|---|---|---|---|
| Maternal exposure during pregnancy | 179 | 21.9 19.1–25.2ROR 24.0 · χ² 3,559 / p <1e-300 | 21.8 EB05 19.3 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 21.5 · ♀ 91% (drug 66%) | no trial data cached |
| Premature baby | 142 | 50.9 43.4–59.7ROR 54.8 · χ² 6,876 / p <1e-300 | 50.4 EB05 43.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 42.7 · ♀ 30% (drug 66%) | no trial data cached |
| Foetal exposure during pregnancy | 138 | 18.3 15.6–21.5ROR 19.7 · χ² 2,249 / p <1e-300 | 18.3 EB05 15.8 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 · ♀ 26% (drug 66%) | no trial data cached |
| Exposure during pregnancy | 86 | 14.9 12.1–18.3ROR 15.6 · χ² 1,105 / p 1e-242 | 14.8 EB05 12.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 15.3 · ♀ 99% (drug 66%) | no trial data cached |
| Premature delivery | 77 | 52.1 41.8–64.9ROR 54.2 · χ² 3,793 / p <1e-300 | 51.2 EB05 42.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 44.0 · ♀ 95% (drug 66%) | no trial data cached |
| Completed suicide (death by suicide) | 41 | 5.3 3.9–7.1ROR 5.3 · χ² 137 / p 5e-32 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.4 · 100% clinician | no trial data cached |
| Medication error | 33 | 6.4 4.6–9.0ROR 6.5 · χ² 146 / p 8e-34 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · ♀ 88% (drug 66%) · 94% clinician | no trial data cached |
| Caesarean section | 33 | 30.3 21.6–42.5ROR 30.8 · χ² 904 / p 6e-199 | 29.8 EB05 22.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 | no trial data cached |
| Amnesia (memory loss) | 31 | 5.1 3.6–7.3ROR 5.2 · χ² 99 / p 1e-23 | 4.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 87% (drug 66%) | no trial data cached |
| Depressed mood | 30 | 6.1 4.3–8.8ROR 6.2 · χ² 124 / p 4e-29 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 93% (drug 66%) | no trial data cached |
| Treatment noncompliance | 29 | 5.8 4.0–8.3ROR 5.8 · χ² 109 / p 7e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · ♀ 93% (drug 66%) | no trial data cached |
| Diabetes mellitus inadequate control | 28 | 17.1 11.8–24.7ROR 17.3 · χ² 407 / p 8e-91 | 16.8 EB05 12.0 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.8 · ♀ 89% (drug 66%) | no trial data cached |
| Cognitive disorder | 25 | 5.8 3.9–8.6ROR 5.9 · χ² 95 / p 1e-22 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 96% (drug 66%) | no trial data cached |
| Pregnancy | 23 | 12.3 8.2–18.4ROR 12.4 · χ² 227 / p 2e-51 | 11.6 EB05 7.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · ♀ 95% (drug 66%) | no trial data cached |
| Pulmonary oedema | 22 | 5.3 3.5–8.0ROR 5.3 · χ² 72 / p 9e-18 | 4.8 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | 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.
- Premature delivery — n=77, PRR 52.1
- Premature baby — n=142, PRR 50.9
- Caesarean section — n=33, PRR 30.3
- Pregnancy — n=23, PRR 12.3
- Drug-induced liver injury — n=20, PRR 7.0
- Hyperkalaemia — n=20, PRR 6.2
- Depressed mood — n=30, PRR 6.1
- Cognitive disorder — n=25, PRR 5.8
- Pulmonary oedema — n=22, PRR 5.3
- Amnesia — n=31, PRR 5.1
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 Labetalol?
In FDA FAERS, the most frequently co-reported reaction terms for Labetalol are premature baby, premature delivery, caesarean section, amnesia, depressed mood, diabetes mellitus inadequate control. 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 Labetalol have an FDA boxed warning?
No. The FDA label retrieved for Labetalol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Labetalol 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 28c91727-e5a8-48b3-a4df-d7bec8feda40, effective 20241007; matched on
openfda.generic_name.exact:"LABETALOL") - 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, 58 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.