Labetalol side effects: what 13,242 FDA adverse event reports show

Labetalol · Labetalol Hydrochloride · 1,160 reaction terms · 51,454 drug–reaction co-reports · data 2026-09-14

Drug class

beta-Adrenergic Blocker

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Labetalol Hydrochloride

openFDA label

Who reports

13,242 reports · 76% serious · 1,362 with death outcome · 64% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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.

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 (related wording) 1Likely indication confounding 3Reporting / coding artifact 2Not in label — unassessed 34

What the badges mean

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.
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. 1,120 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
Ultrasound antenatal screen	44	1,373.4 916.2–2,058.7ROR 1,378.0 · χ² 31,371 / p <1e-300	553.9 EB05 429.7 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=44 · ♀ 41% (drug 64%) · 100% clinician	not reported in cached trials
Zoonotic bacterial infection	14	1,213.9 603.9–2,440.2ROR 1,215.2 · χ² 8,873 / p <1e-300	353.1 EB05 223.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Superimposed pre-eclampsia	10	650.3 311.0–1,359.6ROR 650.8 · χ² 4,129 / p <1e-300	244.9 EB05 142.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Trigemino-cardiac reflex	17	414.6 242.9–707.5ROR 415.1 · χ² 5,220 / p <1e-300	239.7 EB05 158.5 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Neutropenia neonatal	30	242.6 165.2–356.3ROR 243.1 · χ² 6,040 / p <1e-300	185.4 EB05 136.2 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=30 · ♀ 0% (drug 64%)	not reported in cached trials
Trisomy 18	43	199.7 145.5–274.2ROR 200.4 · χ² 7,363 / p <1e-300	164.4 EB05 127.1 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=43 · ♀ 0% (drug 64%) · 100% clinician	not reported in cached trials
Phaeochromocytoma crisis	18	147.1 90.7–238.4ROR 147.3 · χ² 2,255 / p <1e-300	118.0 EB05 79.0 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Dandy-walker syndrome	21	138.9 88.9–216.9ROR 139.1 · χ² 2,515 / p <1e-300	114.6 EB05 79.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=21 · 100% clinician	not reported in cached trials
Hydrops foetalis	49	137.8 102.9–184.4ROR 138.3 · χ² 5,989 / p <1e-300	120.8 EB05 95.0 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=49 · ♀ 26% (drug 64%) · 100% clinician	not reported in cached trials
Withdrawal hypertension	16	136.5 81.9–227.4ROR 136.6 · χ² 1,856 / p <1e-300	109.5 EB05 71.5 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious n=13	not reported in cached trials
Ventricular asystole	14	135.7 78.6–234.3ROR 135.9 · χ² 1,601 / p <1e-300	107.1 EB05 67.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Multiple drug therapy	50	122.1 91.6–162.8ROR 122.6 · χ² 5,459 / p <1e-300	108.7 EB05 85.7 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious n=50 · ♀ 100% (drug 64%) · 92% clinician	not reported in cached trials
Mycobacterium marinum infection	18	96.9 60.2–155.9ROR 97.0 · χ² 1,519 / p <1e-300	83.5 EB05 55.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Foetal disorder	45	89.0 65.9–120.1ROR 89.3 · χ² 3,622 / p <1e-300	81.4 EB05 63.4 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=45 · ♀ 0% (drug 64%)	not reported in cached trials
Macrocephaly	20	87.4 55.7–137.1ROR 87.6 · χ² 1,537 / p <1e-300	77.0 EB05 52.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=20 · 100% clinician	not reported in cached trials
Low birth weight baby	409	85.9 77.8–94.7ROR 88.6 · χ² 32,445 / p <1e-300	81.1 EB05 74.7 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 62.2 · ♀ 39% (drug 64%) · 92% clinician	not reported in cached trials
Pre-eclampsia	238	83.7 73.5–95.2ROR 85.2 · χ² 18,383 / p <1e-300	79.0 EB05 70.9 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=233 · ♀ 97% (drug 64%)	not reported in cached trials
Eclampsia	18	82.4 51.3–132.3ROR 82.5 · χ² 1,298 / p 1e-284	72.5 EB05 48.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Atrioventricular septal defect	22	76.8 50.1–117.8ROR 76.9 · χ² 1,498 / p <1e-300	69.1 EB05 48.1 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=22 · 100% clinician	not reported in cached trials
Chronic kidney disease-mineral and bone disorder	48	73.9 55.3–98.6ROR 74.1 · χ² 3,226 / p <1e-300	68.7 EB05 53.9 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=48 · ♀ 38% (drug 64%)	not reported in cached trials
Polydactyly	51	73.2 55.3–96.8ROR 73.4 · χ² 3,399 / p <1e-300	68.2 EB05 53.9 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=51 · ♀ 0% (drug 64%)	not reported in cached trials
Hypermagnesaemia	26	66.9 45.2–99.0ROR 67.0 · χ² 1,555 / p <1e-300	61.4 EB05 44.0 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=26 · ♀ 100% (drug 64%) · 100% clinician	not reported in cached trials
Nephrogenic anaemia	189	66.7 57.7–77.0ROR 67.6 · χ² 11,663 / p <1e-300	63.6 EB05 56.3 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=189	not reported in cached trials
Cleft lip and palate	45	65.7 48.8–88.5ROR 65.9 · χ² 2,690 / p <1e-300	61.5 EB05 47.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=45 · ♀ 15% (drug 64%) · 100% clinician	not reported in cached trials
Hyperparathyroidism secondary	90	58.3 47.3–71.9ROR 58.7 · χ² 4,832 / p <1e-300	55.6 EB05 46.6 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=90	not reported in cached trials
Maternal exposure during delivery	34	57.4 40.8–80.7ROR 57.5 · χ² 1,762 / p <1e-300	53.8 EB05 40.3 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious n=22 · ♀ 100% (drug 64%) · 100% clinician	not reported in cached trials
Premature delivery	508	51.9 47.6–56.6ROR 53.9 · χ² 24,505 / p <1e-300	50.2 EB05 46.6 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 37.8 · ♀ 98% (drug 64%) · 91% clinician	not reported in cached trials
Hellp syndrome	19	50.2 31.8–79.2ROR 50.2 · χ² 840 / p 5e-185	46.5 EB05 31.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Exomphalos	16	48.1 29.3–79.1ROR 48.2 · χ² 671 / p 3e-148	44.4 EB05 29.0 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Neurodevelopmental disorder	20	48.0 30.8–74.9ROR 48.1 · χ² 848 / p 8e-187	44.8 EB05 30.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=20 · 100% clinician	not reported in cached trials
Accelerated hypertension	11	47.3 26.0–86.1ROR 47.3 · χ² 440 / p 6e-98	42.8 EB05 25.5 · IC025 +2.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=11	not reported in cached trials
Phaeochromocytoma	19	46.5 29.5–73.3ROR 46.5 · χ² 777 / p 2e-171	43.3 EB05 29.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Hypertensive encephalopathy	17	46.2 28.5–74.9ROR 46.3 · χ² 687 / p 9e-152	42.9 EB05 28.4 · IC025 +3.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=17	not reported in cached trials
Gestational hypertension	33	41.9 29.7–59.2ROR 42.0 · χ² 1,244 / p 9e-273	40.0 EB05 29.8 · IC025 +4.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=32 · ♀ 100% (drug 64%)	not reported in cached trials
Foetal heart rate deceleration abnormality	18	41.6 26.0–66.3ROR 41.6 · χ² 655 / p 9e-145	39.0 EB05 26.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Choreoathetosis	17	40.2 24.8–65.0ROR 40.3 · χ² 596 / p 7e-132	37.7 EB05 24.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Premature baby	735	39.5 36.8–42.4ROR 41.7 · χ² 26,882 / p <1e-300	38.5 EB05 36.2 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 29.4 · ♀ 41% (drug 64%) · 93% clinician	not reported in cached trials
Neonatal hypoxia	19	37.2 23.6–58.6ROR 37.3 · χ² 619 / p 6e-137	35.2 EB05 23.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Foetal growth restriction	133	35.6 30.0–42.3ROR 36.0 · χ² 4,342 / p <1e-300	34.7 EB05 30.0 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=133	not reported in cached trials
End stage renal disease	381	33.4 30.2–36.9ROR 34.4 · χ² 11,707 / p <1e-300	32.7 EB05 30.0 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 24.7	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Labetalol as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).

NCT00765648 — Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department (N=226, PHASE4; 1 AE terms posted; arms: Nicardipine; Labetalol)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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
Drug ineffective (drug did not work)	1,036	1.2 1.2–1.3ROR 1.3 · χ² 53 / p 2e-13	1.2 EB05 1.2 · IC025 +0.2	Reporting / coding artifact	serious PRR 2.0	not reported in cached trials
Maternal exposure during pregnancy	975	17.7 16.6–18.8ROR 19.0 · χ² 15,219 / p <1e-300	17.5 EB05 16.6 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 14.3 · ♀ 97% (drug 64%)	not reported in cached trials
Foetal exposure during pregnancy	953	18.8 17.7–20.0ROR 20.2 · χ² 15,890 / p <1e-300	18.6 EB05 17.6 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 14.3 · ♀ 33% (drug 64%) · 91% clinician	not reported in cached trials
Hypertension (high blood pressure)	750	5.6 5.2–6.0ROR 5.9 · χ² 2,859 / p <1e-300	5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 4.8	not reported in cached trials
Premature baby	735	39.5 36.8–42.4ROR 41.7 · χ² 26,882 / p <1e-300	38.5 EB05 36.2 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 29.4 · ♀ 41% (drug 64%) · 93% clinician	not reported in cached trials
Off label use (used outside approved label)	706	1.3 1.2–1.4ROR 1.3 · χ² 47 / p 4e-12	1.3 EB05 1.2 · IC025 +0.2	Reporting / coding artifact	serious PRR 1.4	not reported in cached trials
Exposure during pregnancy	657	16.9 15.7–18.2ROR 17.7 · χ² 9,730 / p <1e-300	16.7 EB05 15.7 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 16.5 · ♀ 98% (drug 64%)	not reported in cached trials
Chronic kidney disease	645	13.4 12.4–14.5ROR 14.1 · χ² 7,367 / p <1e-300	13.3 EB05 12.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	not reported in cached trials
Acute kidney injury (sudden kidney damage)	642	6.7 6.2–7.2ROR 7.0 · χ² 3,114 / p <1e-300	6.6 EB05 6.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	not reported in cached trials
Fatigue (tiredness)	600	1.2 1.1–1.3ROR 1.2 · χ² 25 / p 3e-7	1.2 EB05 1.1 · IC025 +0.2	Labeled adverse reaction exact term	serious PRR 1.1	not reported in cached trials
Renal failure (kidney failure)	579	6.9 6.3–7.4ROR 7.1 · χ² 2,907 / p <1e-300	6.8 EB05 6.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	not reported in cached trials
Nausea	545	1.1 1.0–1.2ROR 1.1 · χ² 4 / p 0.018	1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.1	not reported in cached trials
Headache	511	1.3 1.2–1.4ROR 1.3 · χ² 34 / p 2e-9	1.3 EB05 1.2 · IC025 +0.2	Labeled adverse reaction exact term	serious PRR 1.4	not reported in cached trials
Premature delivery	508	51.9 47.6–56.6ROR 53.9 · χ² 24,505 / p <1e-300	50.2 EB05 46.6 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 37.8 · ♀ 98% (drug 64%) · 91% clinician	not reported in cached trials
Dyspnoea (shortness of breath)	497	1.4 1.3–1.5ROR 1.4 · χ² 56 / p 4e-14	1.4 EB05 1.3 · IC025 +0.3	Labeled adverse reaction exact term	serious PRR 1.2	not reported in cached trials

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.

Ultrasound antenatal screen — n=44, PRR 1,373.4
Neutropenia neonatal — n=30, PRR 242.6
Trisomy 18 — n=43, PRR 199.7
Dandy-walker syndrome — n=21, PRR 138.9
Hydrops foetalis — n=49, PRR 137.8
Foetal disorder — n=45, PRR 89.0
Macrocephaly — n=20, PRR 87.4
Low birth weight baby — n=409, PRR 85.9
Pre-eclampsia — n=238, PRR 83.7
Atrioventricular septal defect — n=22, PRR 76.8

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 hypertension, premature baby, chronic kidney disease, acute kidney injury, fatigue, renal failure. 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, field patient.drug.openfda.generic_name.exact, 1,160 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
ClinicalTrials.gov API v2 (query LABETALOL, results-bearing studies sorted by enrollment)

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.