Prescription medication · Beta-Blocker (Ophthalmic)
timolol
Also sold as Timoptic.
Data updated 2026-05-15
- 11,690
- FDA reportsModerately reported
- 6
- InteractionsFew interactions
- 7
- Recall records
What the data shows
timolol (Timoptic) is a prescription Beta-Blocker (Ophthalmic), reported less often than most tracked drugs (11,690 FDA reports), with 6 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$10.21/unit
Generic Price
$23.09/unit
Generic Available
Yes (22 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Information not available.
Common side effects
Bitter, sour, or unusual taste, Eye burning or stinging, Redness of the eye
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
Side Effects (from patient reports)
Based on 11,690 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for timolol, by number of reports
- Treatment Failure
Treatment Failure
3,042 reports
- Fatigue 470
Fatigue
470 reports
- Hypersensitivity 456
Hypersensitivity
456 reports
- Dizziness 401
Dizziness
401 reports
- Diarrhoea 396
Diarrhoea
396 reports
- Dyspnoea 363
Dyspnoea
363 reports
- Nausea 347
Nausea
347 reports
- Eye Irritation 327
Eye Irritation
327 reports
- Fall 317
Fall
317 reports
- Headache 301
Headache
301 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for timolol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where timolol sits
timolol has more FDA adverse-event reports than 43% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is timolol; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 11,690 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
11,690
Reports Mentioning Death
550
4.7% of reports — not proof of cause
Hospitalization Reports
2,304
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | TREATMENT FAILURE | 3,042 |
| 3 | FATIGUE | 470 |
| 4 | HYPERSENSITIVITY | 456 |
| 5 | DIZZINESS | 401 |
| 6 | DIARRHOEA | 396 |
| 8 | DYSPNOEA | 363 |
| 9 | NAUSEA | 347 |
| 10 | EYE IRRITATION | 327 |
| 11 | FALL | 317 |
| 12 | HEADACHE | 301 |
| 13 | EYE PAIN | 279 |
| 14 | VISION BLURRED | 274 |
| 15 | INTRAOCULAR PRESSURE INCREASED | 272 |
| 16 | ASTHENIA | 256 |
| 17 | PAIN | 256 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
7 DRUG INTERACTIONS Potential additive effect of oral carbonic anhydrase inhibitor with dorzolamide hydrochloride and timolol maleate ophthalmic solution. ( 7.7 ) 7.1 Oral Carbonic Anhydrase Inhibitors There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and dorzolamide hydrochloride and timolol maleate ophthalmic solution. The concomitant administration of dorzolamide hydrochloride and timolol maleate ophthalmic solution and oral carbonic anhydrase inhibitors is not recommended.
Mechanism: Using these drugs together can cause their effects to stack up, which may lead to more side effects throughout your body.
7.8 Clonidine Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
Mechanism: Timolol is a beta-blocker that can make blood pressure rise even higher if you suddenly stop taking clonidine. This happens because the two drugs affect the nervous system's control of blood pressure in opposite ways.
7.7 CYP2D6 Inhibitors Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g., quinidine, SSRIs) and timolol.
Mechanism: Certain medicines can block the body from breaking down timolol. This can lead to higher levels of the drug in your system, which may cause a slow heart rate or feelings of depression.
carvedilol, metoprolol, timolol ↑ beta-blockers Clinical monitoring of patients is recommended.
Mechanism: Darunavir prevents the body from clearing timolol quickly, which can cause the beta-blocker to build up to higher levels.
7.7 CYP2D6 Inhibitors Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g., quinidine, SSRIs) and timolol. There have been no reports of exacerbation of rebound hypertension with ophthalmic timolol maleate.
Mechanism: Using two medications that both contain timolol can lead to an overdose, which may slow your heart rate down too much or cause low blood pressure.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What are the common side effects of timolol?
Does timolol interact with other medications?
What drug class is timolol?
Has timolol been recalled?
Active Recalls
Lack of Assurance of Sterility
Apotex Corp.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Apotex Corp.
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
FDC Limited
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limited
Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
Akorn, Inc
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for timolol: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 11,690.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 4.70%.
- teriparatide Δ 0.02 pts · 111,257 reports · Parathyroid Hormone Analog 4.73%death share
- mometasone Δ 0.03 pts · 17,186 reports · Inhaled Corticosteroid 4.74%death share
- fluocinonide Δ 0.03 pts · 5,460 reports · Topical Corticosteroid 4.67%death share
- tofacitinib Δ 0.05 pts · 181,998 reports · JAK Inhibitor 4.76%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for timolol
The FDA label for timolol (sold under brand names such as Timoptic) classifies it as a prescription-only medication in the Beta-Blocker (Ophthalmic) class. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. Official labeling lists 5 commonly reported side effects, including Bitter, sour, or unusual taste, Eye burning or stinging, Redness of the eye.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 11,690 voluntary reports. The database also lists 6 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $23.09 versus $10.21 for the brand.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 7 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: December 22, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages