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
- The medicine did not work
The medicine did not work
3,042 reports
- Feeling tired 470
Feeling tired
470 reports
- Allergic reaction 456
Allergic reaction
456 reports
- Feeling lightheaded 401
Feeling lightheaded
401 reports
- Loose stools 396
Loose stools
396 reports
- Difficulty breathing 363
Difficulty breathing
363 reports
- Feeling sick to your stomach 347
Feeling sick to your stomach
347 reports
- Eye feels sore 327
Eye feels sore
327 reports
- Accidentally falling down 317
Accidentally falling down
317 reports
- Pain in the head 301
Pain in the head
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) 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.
What to do: This combination is not recommended, and you should talk to your doctor about other options.
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.
What to do: If you need to stop taking clonidine, your doctor should monitor your blood pressure closely and may need to adjust your timolol dose.
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.
What to do: Your doctor should monitor you for a slow pulse or mood changes if you take these medications together.
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.
What to do: Your healthcare provider should monitor you for signs of a slow heart rate or low blood pressure.
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.
What to do: Tell your doctor about all the eye drops and heart medicines you use to avoid taking too much of the same active ingredient.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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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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
Why some drugs demand precise dosing and monitoring
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: December 22, 2025
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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