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Labetalol Side Effects

The most commonly reported side effects of labetalol include foetal exposure during pregnancy, maternal exposure during pregnancy, and premature baby, based on 17,640 FDA adverse event reports from 2004 to 2025. 5.9% of reports found the drug to be ineffective.

Labetalol side effects

Percentages show how often each reaction appears relative to total reports for labetalol.

1
Drug Ineffective5.9%1,035
2
Foetal Exposure During Pregnancy5.8%1,024
3
Maternal Exposure During Pregnancy5.8%1,018
4
Premature Baby4.4%771
5
Hypertension4.3%755
6
Off Label Use4.2%738
7
Chronic Kidney Disease4.0%701
8
Exposure During Pregnancy3.9%692
9
Acute Kidney Injury3.9%686
10
Fatigue3.8%676
11
Renal Failure3.4%599
12
Nausea3.2%565
13
Diarrhoea3.1%542
14
Headache3.1%541
15
Premature Delivery3.1%541

These are voluntary reports and do not establish that labetalol caused these reactions.

Report severity

77.6%Serious13,692 reports
38.9%Hospitalizations6,861 reports
11.0%Fatal1,949 reports

Seriousness is determined by the reporter, not by OpenClaim.

Labetalol drug interactions

Other drugs that appear in adverse event reports alongside labetalol. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Nifedipine5.2%923
2
Aspirin4.0%703
3
Omeprazole3.8%668
4
Amlodipine3.7%646
5
Esomeprazole3.3%578
6
Lenalidomide3.2%569
7
Furosemide3.2%557
8
Hydralazine-hydrochloride3.2%557
9
Pantoprazole-sodium3.1%542
10
Hydrochlorothiazide2.8%501
11
Tacrolimus2.8%490
12
Metformin2.6%453
13
Insulin2.4%417
14
Betamethasone2.2%389
15
Methyldopa2.2%387

Taken alongside

1
Amlodipine21.5%3,794
2
Aspirin17.8%3,144
3
Acetaminophen15.5%2,737
4
Furosemide14.8%2,611
5
Ergocalciferol11.7%2,060
6
Atorvastatin-calcium11.1%1,963
7
Lisinopril10.6%1,868
8
Clonidine10.0%1,756
9
Insulin9.9%1,748
10
Levothyroxine-sodium9.6%1,701
11
Hydralazine-hydrochloride9.6%1,688
12
Prednisone9.2%1,620
13
Hydrochlorothiazide8.7%1,533
14
Omeprazole8.4%1,488
15
Losartan-potassium8.2%1,444

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports labetalol side effects

56.2% of labetalol adverse event reports involve female patients and 34.9% involve male patients. The largest age group is adult at 55%. These figures reflect who reports side effects, not underlying risk.

Sex

Female56.2%
Male34.9%
Unknown8.8%

Age group

< 27.1%
2–111.7%
12–171.4%
18–6454.6%
65+35.1%

What is labetalol used for

Conditions and purposes for which patients were taking labetalol when the adverse event was reported.

Accelerated HypertensionAcute Kidney InjuryAdenocarcinomaAdrenergic SyndromeAdrenocortical Insufficiency AcuteAngina PectorisAntiandrogen TherapyAnticoagulant TherapyAnxietyAorta Coarctation RepairAortic DissectionAortic InjuryArrhythmiaAtrial FibrillationAtrioventricular Block

Showing 15 of 376 indications

Labetalol brand names and reporting trend

Labetalol is sold under the brand name Normozide.

Brand names

Normozide23

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking labetalol with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.