What the label lists and what reports show
Labetalol side effects
Labetalol's FDA label lists its adverse reactions in its own words. FAERS holds 13,250 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is premature baby (735 reports).
- Generic listed
Check it at the source: the labetalol FDA label on DailyMed (effective March 2, 2026, Zydus Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost adverse effects are mild and transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 months duration, discontinuation of labetalol hydrochloride tablets due to one or more adverse effects was required in 7% of all patients. In these same trials, other agents with solely beta-blocking activity used in the control groups led to discontinuation in 8% to 10% of patients and acentrally acting alpha-agonist led to discontinuation in 30% of patients. The incidence rates of adverse reactions listed in the following table were derived from multicenter controlled clinical trials, comparing labetalol hydrochloride, placebo, metoprolol and propranolol, over treatment periods of 3 and 4 months. Where the frequency of adverse effects for labetalol hydrochloride and placebo is similar, causal relationship is uncertain. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Labetalol Hydrochloride (N=227)% | Placebo (N=98)% | Propranolol (N=84)% | Metoprolol (N=49)% |
|---|---|---|---|---|
| Fatigue | 5 | 0 | 12 | 12 |
| Asthenia | 1 | 1 | 1 | 0 |
| Headache | 2 | 1 | 1 | 2 |
| Nausea | 6 | 1 | 1 | 2 |
| Vomiting | <1 | 0 | 0 | 0 |
| Dyspepsia | 3 | 1 | 1 | 0 |
| Abdominal pain | 0 | 0 | 1 | 2 |
| Diarrhea | <1 | 0 | 2 | 0 |
| Taste distortion | 1 | 0 | 0 | 0 |
| Dizziness | 11 | 3 | 4 | 4 |
| Paresthesias | <1 | 0 | 0 | 0 |
| Drowsiness | <1 | 2 | 2 | 2 |
| Nasal stuffiness | 3 | 0 | 0 | 0 |
| Ejaculation failure | 2 | 0 | 0 | 0 |
| Impotence | 1 | 0 | 1 | 3 |
| Increased sweating | <1 | 0 | 0 | 0 |
| Edema | 1 | 0 | 0 | 0 |
| Postural hypotension | 1 | 0 | 0 | 0 |
| Bradycardia | 0 | 0 | 5 | 12 |
| Dyspnea | 2 | 0 | 1 | 2 |
| Rash | 1 | 0 | 0 | 0 |
| Vision abnormality | 1 | 0 | 0 | 0 |
| Vertigo | 2 | 1 | 0 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Zydus Pharmaceuticals USA Inc., effective March 2, 2026 (SPL set 5942a5a8-c3c1-4ecb-921e-9bc92393bdf8), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,250 reports list labetalol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,362 are coded as a death and 5,049 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Labetalol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions