Labetalol hydrochloride: adverse event reports filed with FDA

791

reports as suspect product

0% of all reports · about 35 a year

88

reports, 12 months to June 2026

95 in the 12 months before

80.7%

marked serious by the reporter

78.7% across the class

11.8%

record death among outcomes, as reported

93 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Labetalol hydrochloride reports recording the termmedian drug in beta-adrenergic blocker

1. Maternal exposure during pregnancythe mother took the medicine during pregnancy17.7%140
2. Drug ineffectivethe medicine did not work as expected15.4%122
3. Foetal exposure during pregnancythe unborn baby was exposed to the medicine15.3%121
4. Premature babya baby born early14.4%114
5. Exposure during pregnancythe medicine was taken during pregnancy9.4%74
6. Low birth weight baby9.1%72
7. Premature delivery9%71
8. Hypertensionhigh blood pressure6.3%50
9. Completed suicidedeath by suicide4.7%37
10. Off label useused for a purpose or in a way not on the label4.6%36
11. Product use issuea problem in how the product was used4.6%36
12. Foetal disorder3.9%31
13. Drug hypersensitivityan allergic-type reaction to a medicine3.3%26
14. Medication errora mistake in prescribing, dispensing or taking a medicine3.3%26
15. Oedema peripheralswelling of the legs, ankles or hands3.2%25
16. Abdominal discomfortstomach discomfort3%24
17. Amnesiamemory loss2.9%23
18. Diabetes mellitus inadequate controldiabetes not well controlled2.9%23
19. Nauseafeeling sick2.9%23
20. Neutropenia neonatal2.9%23
21. Blood pressure inadequately controlled2.8%22
22. Cognitive disorderproblems with thinking or memory2.8%22
23. Contusiona bruise2.8%22
24. Depressed moodlow mood2.8%22
25. Exercise tolerance decreased2.8%22
26. Mobility decreasedreduced ability to move about2.8%22
27. Diarrhoealoose or frequent stools2.5%20
28. Peripheral swellingswelling of the arms or legs2.5%20
29. Product use in unapproved indicationused for a purpose not on the label2.4%19
30. Treatment noncompliancethe treatment was not taken as directed2.4%19

Top 30 of 183 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 22 drugs in the beta-adrenergic blocker class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 148,208 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 54.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 791 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the beta-adrenergic blocker class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Labetalol hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,184) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.