Prescription medicine
Timolol Brand names: Timoptic, Betimol, Timoptic-Xe, Istalol
Timolol (Timoptic) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $0.774 per mL (Timolol maleate 0.5% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the timolol FDA label on DailyMed (effective June 27, 2025, Thea Pharma Inc.); the NDA 18086 record on Drugs@FDA; every timolol label on DailyMed.
Highlights of the record
FDA label of June 27, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBetimol ® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Forms and strengths
- 5 mg
- 10 mg
- 20 mg
- 2.5 mg/ml
- 2.56 mg/ml
- 3.4 mg/ml
- 5 mg/ml
- 5.12 mg/ml
- 6.8 mg/ml
Solution/ drops; solution; solution (gel forming / drops); tablet.
On the market
- Earliest approval on file
- August 17, 1978 Timoptic, Bausch And Lomb Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 46 first April 13, 1989; 23 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 22 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.774 per mL Timolol maleate 0.5% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 20 since 2013 0 Class I among all firms' recalls; latest July 5, 2025
- FAERS reports
- 9,878 through July 30, 2026
What is timolol used for?
From the label: indications and usageBetimol ® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Conditions named in the indications of timolol's FDA labels, with every medicine labeled for each:
From other timolol labelsGlaucoma: INDICATIONS AND USAGE Betimol ® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
High blood pressure: INDICATIONS AND USAGE Hypertension Timolol maleate tablets are indicated for the treatment of hypertension.
Migraine: Migraine Timolol is indicated for the prophylaxis of migraine headache.
FDA pharmacologic class: beta-Adrenergic Blocker.
Source: FDA drug label (BETIMOL), Thea Pharma Inc., effective June 27, 2025 (SPL set 3ae775f4-340c-4bf4-aa49-8a31daba0f8b), via openFDA; the full label on DailyMed
Is there a generic for timolol (Timoptic)?
The FDA approved the first generic timolol on April 13, 1989. 46 generic applications are approved; 23 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists timolol from 22 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1978 earliest approval on file
- 1989 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for timolol (Timoptic)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.774 per mL (Timolol maleate 0.5% eye drops), down 6% from $0.827 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Timolol maleate 0.5% eye drops (generic)
- Istalol 0.5% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Timolol 0.25% gel-solution | Generic | $6.38 per mL | n/a | -66% |
| Timolol 0.5% eye drop | Generic | $22.05 per mL | n/a | +24% |
| Timolol 0.5% eye drops | Generic | $21.67 per mL | n/a | -1% |
| Timolol 0.5% gel-solution | Generic | $8.30 per mL | n/a | -40% |
| Timolol 0.5% gfs gel-solution | Generic | $8.30 per mL | n/a | -40% |
| Timolol maleate 0.25% eye drop | Generic | $0.644 per mL | n/a | +2% |
| Timolol maleate 0.5% eye drop | Generic | $1.26 per unit | n/a | -45% |
| Timolol maleate 0.5% eye drops | Generic | $0.774 per mL | n/a | -6% |
| Betimol 0.5% eye drops | Brand | $31.12 per mL | n/a | -0.3% |
| Istalol 0.5% eye drops | Brand | $79.89 per mL | n/a | -0.1% |
| Timoptic 0.5% ocudose drop | Brand | $10.32 per unit | n/a | +0.6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has timolol been recalled?
The FDA's Enforcement Report lists 20 recalls naming timolol since 2013: 0 Class I (the most serious), 12 Class II, 8 Class III; 10 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 5, 2025 | Class II | FDC Limited | Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. |
| April 18, 2025 | Class II | 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. |
| January 23, 2025 | Class II | 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. |
| December 5, 2024 | Class II | 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. |
| October 29, 2024 | Class II | 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 |
| August 12, 2024 | Class II | 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. |
| July 18, 2024 | Class II | FDC Limited | Defective container; yellow colored spike from cap lodged in the nozzle |
| April 25, 2024 | Class II | FDC Limited | Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the timolol label say about other medicines?
The timolol label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 12 other medicines name timolol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Benzalkonium | warnings and precautions | Solution contains benzalkonium chloride, an anti-microbial preservative which may be absorbed by soft contact lenses. |
| Clonidine | drug interactions | Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. |
| Epinephrine | drug interactions | Injectable Epinephrine (See PRECAUTIONS, General, Anaphylaxis .) |
| Quinidine | drug interactions | … Potentiated systemic beta-blockade (e.g., decreased heart rate) has been reported during combined treatment with quinidine and timolol. |
Other labels that name timolol
Source: FDA drug label (BETIMOL), 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 for timolol?
The FDA Adverse Event Reporting System holds 9,878 reports that list timolol among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as timolol?
16 other medicines are given the same way (ophthalmic) and in the same FDA class as timolol or labeled mainly for the same use (glaucoma), the same class first. Glaucoma lists all 20 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (ophthalmic) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Betaxolol | Glaucoma | none listed | $8.97 per mL 0.5% eye drop | No current entry |
| Carteolol | Glaucoma | 1 labeler | $1.63 per mL 1% eye drops | No current entry |
| Levobunolol | Glaucoma | 1 labeler | $2.82 per mL 0.5% eye drops | No current entry |
| Brimonidine | Glaucoma | 12 labelers | $9.06 per mL 0.1% drop | No current entry |
| Bimatoprost | Glaucoma | 13 labelers | $6.97 per mL 0.03% eye drops | No current entry |
| Latanoprost | Glaucoma | 14 labelers | $1.58 per mL 0.005% eye drops | No current entry |
| Travoprost | Glaucoma | 11 labelers | $9.07 per mL 0.004% eye drop | A presentation being discontinued |
| Dorzolamide | Glaucoma | 14 labelers | $0.835 per mL 2% eye drops | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does timolol compare with medicines for the same use?
6 side-by-side pages set timolol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to timolol
- 16 medicines for the same use
- Other beta blockers
- the pharmacologic class, with prices and generics
- Timolol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other