What the label lists and what reports show
Betaxolol side effects
Betaxolol's FDA label lists its adverse reactions in its own words. FAERS holds 1,304 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 fall (107 reports).
- Generic listed
Check it at the source: the betaxolol FDA label on DailyMed (effective December 20, 2023, Epic Pharma LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost adverse reactions have been mild and transient and are typical of beta-adrenergic blocking agents, eg, bradycardia, fatigue, dyspnea, and lethargy. Withdrawal of therapy in U.S. and European controlled clinical trials has been necessary in about 3.5% of patients, principally because of bradycardia, fatigue, dizziness, headache, and impotence. Frequency estimates of adverse events were derived from controlled studies in which adverse reactions were volunteered and elicited in U.S. studies and volunteered and/or elicited in European studies. In the U.S., the placebo-controlled hypertension studies lasted for 4 weeks, while the active-controlled hypertension studies had a 22- to 24-week double-blind phase. The following doses were studied: betaxolol–5, 10, 20, and 40 mg once daily; atenolol–25, 50, and 100 mg once daily; and propranolol–40, 80, and 160 mg b.i.d. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Betaxolol label published by PuraCap Laboratories LLC of October 31, 2019; the label quoted above does not print one.
| Dose Range Body System/Adverse Reaction | Betaxolol (N=509) 5-40 mg q.d.* (%) | Propranolol (N=73) 40-160 mg b.i.d. (%) | Atenolol (N=75) 25-100 mg q.d. (%) | Placebo (N=109) (%) |
|---|---|---|---|---|
| Cardiovascular | 8.1 | 4.1 | 12.0 | 0 |
| Symptomatic bradycardia | 0.8 | 1.4 | 0 | 0 |
| Edema | 1.8 | 0 | 0 | 1.8 |
| Skin | 1.2 | 0 | 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, Epic Pharma LLC, effective December 20, 2023 (SPL set bf716efe-0a9f-43b1-9d8a-c69330b82e18), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,304 reports list betaxolol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 138 are coded as a death and 672 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 22 reactions below, 7 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?
- Betaxolol: 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