What the label lists and what reports show
Timolol side effects
Timolol's FDA label: “The most frequently reported ocular event in clinical trials was burning/stinging on instillation and was comparable between Betimol ® and timolol maleate (approximately one in eight patients).” FAERS holds 9,878 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 fatigue (527 reports).
- Generic listed
Check it at the source: the timolol FDA label on DailyMed (effective June 27, 2025, Thea Pharma Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most frequently reported ocular event in clinical trials was burning/stinging on instillation and was comparable between Betimol ® and timolol maleate (approximately one in eight patients).
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 Timolol Maleate label published by Rising Pharma Holdings, Inc. of June 11, 2024; the label quoted above does not print one.
| Reaction | Timolol Maleate (n=176) % | Placebo (n=168) % |
|---|---|---|
| fatigue/tiredness | 3.4 | 0.6 |
| headache | 1.7 | 1.8 |
| chest pain | 0.6 | 0 |
| asthenia | 0.6 | 0 |
| bradycardia | 9.1 | 0 |
| arrhythmia | 1.1 | 0.6 |
| syncope | 0.6 | 0 |
| edema | 0.6 | 1.2 |
| dyspepsia | 0.6 | 0.6 |
| nausea | 0.6 | 0 |
| pruritus | 1.1 | 0 |
| dizziness | 2.3 | 1.2 |
| vertigo | 0.6 | 0 |
| paresthesia | 0.6 | 0 |
| decreased libido | 0.6 | 0 |
| dyspnea | 1.7 | 0.6 |
| bronchial spasm | 0.6 | 0 |
| rales | 0.6 | 0 |
| eye irritation | 1.1 | 0.6 |
| tinnitus | 0.6 | 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.
From the label: adverse reactions, continuedThe most frequently reported ocular event in clinical trials was burning/stinging on instillation and was comparable between Betimol ® and timolol maleate (approximately one in eight patients). The following adverse events were associated with use of Betimol ® in frequencies of more than 5% in two controlled, double-masked clinical studies in which 184 patients received 0.25% or 0.5% Betimol ® : OCULAR: Dry eyes, itching, foreign body sensation, discomfort in the eye, eyelid erythema, conjunctival injection, and headache. BODY AS A WHOLE: Headache. The following side effects were reported in frequencies of 1 to 5%: OCULAR: Eye pain, epiphora, photophobia, blurred or abnormal vision, corneal fluorescein staining, keratitis, blepharitis and cataract. BODY AS A WHOLE: Allergic reaction, asthenia, common cold and pain in extremities. CARDIOVASCULAR: Hypertension. DIGESTIVE: Nausea. METABOLIC/NUTRITIONAL: Peripheral edema. NERVOUS SYSTEM/PSYCHIATRY: Dizziness and dry mouth. RESPIRATORY: Respiratory infection and sinusitis. In addition, the following adverse reactions have been reported with ophthalmic use of beta blockers: OCULAR: Conjunctivitis, blepharoptosis, decreased corneal sensitivity, visual disturbances including refractive changes, diplopia and retinal vascular disorder. BODY AS A WHOLE: Chest pain. …
Source: FDA drug label, Thea Pharma Inc., effective June 27, 2025 (SPL set 3ae775f4-340c-4bf4-aa49-8a31daba0f8b), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,878 reports list timolol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 586 are coded as a death and 2,176 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. Reports rose sharply in 2020 (1,558, against a median of 503 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 11 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?
- Timolol: 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