Timolol
Timolol is a beta-blocker used as eye drops to lower high pressure inside the eye (ocular hypertension and open-angle glaucoma), and as tablets to treat high blood pressure, protect the heart after a heart attack, and prevent migraine.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 43 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Timolol is a beta-blocker, used mostly as eye drops that lower high pressure inside the eye (ocular hypertension and open-angle glaucoma) by slowing fluid production, and as tablets for high blood pressure, heart protection after a heart attack and migraine prevention; around since about 1978 and available as a generic, it is a long-standing glaucoma standby. The drops are usually well tolerated, and a brief sting as they go in is what most people notice. Even from the eye it reaches the bloodstream and can tighten airways or slow the heart, so tell every prescriber about asthma, COPD or heart conditions. Never stop the tablets suddenly, since chest pain can flare.
Clinical pearls
- Pressing gently on the inner eye corner after each drop keeps more medicine in the eye, less in your bloodstream.
- If you use the gel-forming drops, shake once and put any other eye drops in at least 10 minutes earlier.
- Mention the drops to every doctor, since calcium channel blockers, digoxin and other beta-blockers can stack up and slow the heart.
- If you use insulin or diabetes medicines, timolol can mask the racing heartbeat that usually warns of low blood sugar.
Patient information guide A plain-language walkthrough of Timolol, written from its FDA label.
What Timolol is used for
▾
Timolol is used in different ways depending on the product.
- Eye solutions and gels (including Timoptic, Timoptic-XE, Istalol, Betimol, Timolol GFS and preservative-free unit-dose vials): lower raised eye pressure in ocular hypertension or open-angle glaucoma.
- Preservative-free unit-dose timolol eye solution: may be used if you are sensitive to the preservative benzalkonium chloride or a preservative-free product is advisable.
- Timolol Maleate tablets (oral): treat high blood pressure, alone or with other blood pressure medicines such as thiazide-type diuretics.
- Timolol Maleate tablets (oral): reduce cardiovascular death and repeat heart attack in stable patients after the acute phase of a heart attack.
- Timolol Maleate tablets (oral): prevent migraine headache.
How Timolol works
▾
Timolol blocks both beta-1 and beta-2 receptors, which respond to adrenaline-type signals. Blocking them lowers the heart's output and can lower blood pressure. In the eye, timolol lowers pressure, mainly by reducing production of the fluid inside the eye. High eye pressure raises the risk of vision loss and optic nerve damage in glaucoma.
Timolol dosage
▾
Eye drops are used in the affected eye(s) once or twice a day depending on the product. Gel-forming products are shaken once first and used once a day. Preservative-free unit-dose vials are used right after opening and any leftover is thrown away. Tablets are taken by mouth. Follow your prescriber and product label.
Dosing details from the FDA-approved label
From the Timolol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Preservative-free timolol maleate ophthalmic solution (unit dose vial/OCUDOSE) - usual starting dose
- One drop of 0.25% solution in the affected eye(s) administered twice a day
- If the clinical response is not adequate, may be changed to one drop of 0.5% solution in the affected eye(s) administered twice a day
- Maximum: Dosages above one drop of 0.5% twice a day generally have not been shown to produce further reduction in intraocular pressure
- Use one unit immediately after opening and discard the remainder; evaluate intraocular pressure after approximately 4 weeks of treatment
- Preservative-free timolol maleate ophthalmic solution - maintenance when intraocular pressure is maintained at satisfactory levels
- One drop once a day in the affected eye(s)
- Response to once-a-day dose is best determined by measuring intraocular pressure at different times during the day
- Timolol maleate ophthalmic gel forming solution
- One drop (either 0.25% or 0.5%) in the affected eye(s) once a day
- Maximum: Dosages higher than one drop of 0.5% once a day have not been studied
- Invert the closed container and shake once before each use; give other topical ophthalmic medications at least 10 minutes before; evaluate intraocular pressure after approximately 4 weeks
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Patients should be instructed to invert the closed container and shake once before each use. It is not necessary to shake the container more than once. Other topically applied ophthalmic medications should be administered at least 10 minutes before Timolol Maleate Ophthalmic Gel Forming Solution [see PRECAUTIONS , Information for Patients and accompanying INSTRUCTIONS FOR USE ]. Timolol Maleate Sterile Ophthalmic Gel Forming Solution is available in concentrations of 0.25% and 0.5%. The dose is one drop of Timolol Maleate Ophthalmic Gel Forming Solution (either 0.25% or 0.5%) in the affected eye(s) once a day. Because in some patients the pressure-lowering response to Timolol Maleate Ophthalmic Gel Forming Solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Timolol Maleate Ophthalmic Gel Forming Solution. Dosages higher than one drop of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution once a day have not been studied. If the patient’s intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy can be considered. The concomitant use of two topical beta-adrenergic blocking agents is not recommended [see PRECAUTIONS , Drug Interactions , Beta-Adrenergic Blocking Agents ]. When patients have been switched from therapy with Timolol Maleate Ophthalmic Solution administered twice daily to Timolol Maleate Ophthalmic Gel Forming Solution administered once daily, the ocular hypotensive effect has remained consistent.
Read the full Dosage and Administration section on DailyMed →
Timolol side effects
▾
Most side effects of the eye drops are local to the eye.
Common side effects
- Burning and stinging when the eye drops go in (most common)
- Blurred vision
- Eye redness (conjunctival injection)
- Itching
- Headache
- Decreased visual acuity (sharpness of vision)
- Cataract
- Infection
When to get medical help
- Get help right away for wheezing, trouble breathing or chest tightness, especially if you have asthma or lung disease.
- Call your doctor at the first sign of heart failure, such as swelling or unusual shortness of breath.
- Seek help for a very slow heartbeat, fainting, or chest pain.
- Report signs of a serious allergic reaction, such as swelling of the face or lips, hives or widespread rash.
- Tell your doctor about new or worsening muscle weakness, double vision or drooping eyelid, especially with myasthenia gravis.
- Call your doctor about eye pain, discharge or worsening eye irritation.
- Do not stop timolol tablets suddenly; angina can worsen and heart attack has occurred after abrupt stopping.
Timolol warnings and precautions
▾
- Can trigger severe breathing problems in people with asthma, and is not for people with asthma or severe COPD.
- Can cause or worsen heart failure and slow the heartbeat.
- Stopping the tablets suddenly can worsen angina or cause a heart attack.
- May hide signs of low blood sugar and an overactive thyroid.
- May worsen muscle weakness in myasthenia gravis.
- May make allergic reactions more intense and less responsive to usual epinephrine doses.
- Can add to the risks of general anesthesia during surgery.
- Eye bottles can become contaminated; avoid touching the tip.
Timolol interactions
▾
Timolol can add to the effects of other heart-slowing or blood-pressure-lowering medicines.
- Other beta-blockers: additive effects; two eye beta-blockers together are not recommended.
- Calcium channel blockers: conduction problems, heart failure, low blood pressure.
- Reserpine-type drugs: low blood pressure and slow heartbeat.
- Digitalis: further slows heart conduction.
- Quinidine (CYP2D6 inhibitors): stronger beta-blocker effects.
- Clonidine: oral beta-blockers may worsen rebound high blood pressure.
Interactions listed in the FDA-approved label
From the Timolol prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Beta-adrenergic blocking agents (oral or topical): Potential additive effects of beta-blockade, both systemic and on intraocular pressure. Observe patients receiving an oral beta-blocker with timolol; concomitant use of two topical beta-adrenergic blocking agents is not recommended.
- Calcium antagonists (oral or intravenous): Possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. Use caution; in patients with impaired cardiac function, co-administration should be avoided.
- Catecholamine-depleting drugs (e.g., reserpine): Possible additive effects and production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension. Close observation of the patient is recommended.
- Digitalis and calcium antagonists: May have additive effects in prolonging atrioventricular conduction time.
- CYP2D6 inhibitors (e.g., quinidine): Potentiated systemic beta-blockade (e.g., decreased heart rate) has been reported during combined treatment with timolol.
- Clonidine: Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow withdrawal of clonidine; no reports of exacerbation with ophthalmic timolol maleate.
Read the label’s full interactions text
7 DRUG INTERACTIONS Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade. ( 7.1 ) Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension. ( 7.2 ) Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. ( 7.3 ) Digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time. ( 7.4 ) Potentiated systemic beta-blockade (e.g., decreased heart rate) has been reported during combined treatment with quinidine and timolol. ( 7.5 ) 7.1 Beta-Adrenergic Blocking Agents Patients who are receiving a beta-adrenergic blocking agent orally and Timolol Maleate Ophthalmic Solution 0.5% should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. 7.2 Calcium Antagonists Caution should be used in the co-administration of beta-adrenergic blocking agents, such as Timolol Maleate Ophthalmic Solution 0.5%, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, co-administration should be avoided. 7.3 Catecholamine-Depleting Drugs Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension. 7.4 Digitalis and Calcium Antagonists The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Timolol
▾
- Not for asthma, a history of asthma or severe COPD.
- Not for a very slow heartbeat, second- or third-degree heart block, overt heart failure or cardiogenic shock.
- Not for people allergic to any component.
- Use in pregnancy only if the benefit justifies the risk.
- Timolol passes into breast milk.
- Safety and effectiveness of the eye solution in children are not established.
- No overall differences in safety or effectiveness were seen between older and younger adults.
- Remove soft contact lenses before drops with benzalkonium chloride; wait 15 minutes to reinsert.
Timolol overdose
▾
Overdose with a beta-blocker can cause a slow heartbeat, low blood pressure, breathing spasm (bronchospasm) and acute heart failure. One reported tablet overdose caused heart block. Timolol should be stopped and the person watched closely in a medical setting. Seek emergency help or call poison control.
What Timolol does in the body
▾
Timolol blunts the heart's response to adrenaline-type signals, lowering resting heart rate and the rise in heart rate and blood pressure with exercise. With ongoing use, blood pressure falls within a few days, and full effect can take a few weeks. In the eye, it lowers pressure within about half an hour, peaking in one to two hours, and can last up to 24 hours.
How your body processes Timolol
▾
After a tablet is swallowed, about 90% is absorbed. Blood levels appear within half an hour and peak in one to two hours. About half is broken down in the liver on the first pass. Timolol's half-life is about 4 hours, and it and its breakdown products leave through the kidneys.
How to store Timolol
▾
Store at 15° to 25°C (59° to 77°F). Do not freeze. Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Timolol
183 supplements and herbal products have documented interactions with Timolol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 5
- Moderate · 151
- Minor · 27
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Timolol has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Timolol: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Timolol — the kind of thing our pharmacy team would talk through with you at the counter.
What is timolol for?
▾
How do I use the eye drops?
▾
What side effects should I expect?
▾
Can I wear contact lenses?
▾
Who shouldn't use timolol?
▾
Can I stop the tablets if I feel fine?
▾
Is Timolol available over the counter?
▾
When was Timolol first available?
▾
Who makes Timolol?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Timolol on HelloPharmacist
Timolol forms and strengths (how it comes)
Timolol is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Eye drops
How this form is used
- Betimol, Istalol and Timolol GFS are used for elevated eye pressure in ocular hypertension or open-angle glaucoma.
- Timolol Maleate Ophthalmic Gel Forming Solution is used for elevated eye pressure in ocular hypertension or open-angle glaucoma.
- Timolol Maleate Ophthalmic Gel Forming Solution: invert the closed container and shake once before each use; one drop in the affected eye(s) once a day.
- Timolol Maleate Ophthalmic Gel Forming Solution: use other eye medicines at least 10 minutes beforehand.
- Betimol: pressure response may take a few weeks to settle, so eye pressure is rechecked after about 4 weeks.
Show 2 more strengths Show fewer strengths
Eye ointment
Tablet
How this form is used
- Timolol Maleate tablets are used for high blood pressure, alone or with other blood pressure medicines.
- Timolol Maleate tablets reduce the risk of cardiovascular death and repeat heart attack in stable patients who survived the acute phase of a heart attack.
- Timolol Maleate tablets are used to prevent migraine headaches.
- Timolol Maleate tablets: do not stop suddenly; the dose is lowered gradually over one to two weeks when stopping long-term use.
Oral solution
Timolol on the U.S. market: products, makers and brands
How Timolol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
23 companies list 73 Timolol product records with the FDA, mostly as eye drops, eye ointment, tablet; the earliest marketing or approval year on record is 1978. Brand names on the directory include Blocadren, Timoptic, Istalol and 8 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (17) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Timolol is used (Medicaid data)
A general measure of how commonly Timolol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Timolol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Timolol prescribed? Of the 1,601 medications we measure, Timolol ranks #406 by Medicaid prescriptions — more than 75% of them.
Utilization by Timolol product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
12 HR timolol 5 MG/ML Ophthalmic Solution Most dispensed
Summed across the 21 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1992303
timolol 0.005 MG/MG Ophthalmic Gel
Summed across the 6 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313408
timolol 2.5 MG/ML Ophthalmic Solution
Summed across the 9 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1923428
24 HR timolol 5 MG/ML Ophthalmic Solution
Summed across the 5 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1992299
timolol hemihydrate 5 MG/ML Ophthalmic Solution
Summed across the 3 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2702393
Preservative-Free timolol 5 MG/ML Ophthalmic Solution
Summed across the 4 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1922894
timolol 0.0025 MG/MG Ophthalmic Gel
Summed across the 4 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313407
Preservative-Free timolol 2.5 MG/ML Ophthalmic Solution
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1922876
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Timolol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 53 of 122 listed Timolol NDCs with Medicaid activity.
Compare Timolol products
A representative set of FDA-listed product records for Timolol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 5 mg/mL | Ophthalmic | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 6.8 mg/mL | Ophthalmic | Armas Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Aurobindo Pharma Limited | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Bausch & Lomb Americas Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 5 mg/mL | Ophthalmic | Bausch & Lomb Americas Inc. × 3 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 6.8 mg/mL | Ophthalmic | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 2.5 mg/mL | Ophthalmic | Bausch & Lomb Incorporated × 2 listings | NDA | View NDC → |
| 3.4 mg/mL | Ophthalmic | Bausch & Lomb Incorporated | NDA | View NDC → |
| 5 mg/mL | Ophthalmic | Bausch & Lomb Incorporated × 3 listings | NDA | View NDC → |
| 6.8 mg/mL | Ophthalmic | Bausch & Lomb Incorporated | NDA | View NDC → |
| 5 mg/mL | Ophthalmic | Caplin Steriles Limited × 3 listings | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Dr. Reddy's Laboratories, Inc. | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Dr. Reddy's Laboratories, Inc. | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | First Nation Group, LLC | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | First Nation Group, LLC | ANDA | View NDC → |
| 3.4 mg/mL | Ophthalmic | Ingenus Pharmaceuticals, LLC | ANDA | View NDC → |
| 6.8 mg/mL | Ophthalmic | Ingenus Pharmaceuticals, LLC | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Leading Pharma, LLC | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Lifestar Pharma LLC × 2 listings | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Lifestar Pharma LLC × 2 listings | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Micro Labs Limited | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Micro Labs Limited | ANDA | View NDC → |
| 6.8 mg/mL | Ophthalmic | Micro Labs Limited | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Nordic Pharma, Inc. | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | NorthStar RxLLC | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | NorthStar RxLLC × 2 listings | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Pacific Pharma, Inc. | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Pacific Pharma, Inc. | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Sandoz Inc | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Sandoz Inc | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Somerset Therapeutics, LLC × 3 listings | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Somerset Therapeutics, LLC × 8 listings | ANDA | View NDC → |
| 2.56 mg/mL | Ophthalmic | Thea Pharma Inc. | NDA | View NDC → |
| 5.12 mg/mL | Ophthalmic | Thea Pharma Inc. | NDA | View NDC → |
| 💊Eye ointment | ||||
| 2.5 mg/mL | Ophthalmic | Fosun Pharma Usa Inc | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Fosun Pharma Usa Inc | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Gland Pharma Limited | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Gland Pharma Limited | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Sagent Pharmaceuticals | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Sagent Pharmaceuticals | ANDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Sandoz Inc | NDA | View NDC → |
| 5 mg/mL | Ophthalmic | Sandoz Inc | NDA | View NDC → |
| 2.5 mg/mL | Ophthalmic | Somerset Therapeutics, LLC | ANDA | View NDC → |
| 5 mg/mL | Ophthalmic | Somerset Therapeutics, LLC | ANDA | View NDC → |
| 💊Tablet | ||||
| 10 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 5 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
Showing 73 of 73 products — FDA National Drug Code Directory. See every product, package size and price: browse all 73 Timolol NDCs →
Timolol side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Timolol — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Timolol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Timolol FDA approval history
How Timolol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Timolol recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 9 Timolol recalls since July 2021. Seven of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jers… Lots: Lot#: 083L061, Exp.: 11/2025. FDA record D-0543-2025 →
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jer… Lots: Lot #: 083I098, Exp. Date 08/31/2025 FDA record D-0403-2025 →
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jers… Lots: Lot#: 083J033, Exp. Date 09/2025 FDA record D-0214-2025 →
- Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Je… Lots: Lot #: 083I006, Exp 08/31/2025 FDA record D-0114-2025 →
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jers… Lots: Lot #: 083L051, Exp. Date: 11/2025 FDA record D-0035-2025 →
- Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, D… Lots: Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025. FDA record D-0642-2024 →
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jers… Lots: Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25 FDA record D-0632-2024 →
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Dist… Lots: Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025. FDA record D-0488-2024 →
- Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15 Lots: Lot #: 435019, Exp. Date 11/2024 FDA record D-0374-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 10600 3 dose forms · 13 strengths
-
Dose form (SCDF) Ophthalmic Gel RxCUI 376542In current FDA listingsClinical drug / strength (SCD) 0.001 MG/MGRxCUI 3885220.0025 MG/MGRxCUI 3134070.005 MG/MGRxCUI 313408 -
Dose form (SCDF) Ophthalmic Solution RxCUI 374134In current FDA listingsClinical drug / strength (SCD) Preservative-Free timolol 2.5 MG/MLRxCUI 1922876Preservative-Free timolol 5 MG/MLRxCUI 1922894hemihydrate 2.5 MG/MLRxCUI 2702398hemihydrate 5 MG/MLRxCUI 27023932.5 MG/MLRxCUI 192342812 HR timolol 5 MG/MLRxCUI 199230324 HR timolol 5 MG/MLRxCUI 1992299 -
Dose form (SCDF) Oral Tablet RxCUI 374135In current FDA listings
Look up RxCUI 10600 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Timolol supply and shortage status
Whether Timolol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Timolol costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Solution/ Drops · Ophthalmic | 5 mg/mL | $79.76–$80.01 per mL | NDC details & price history |
| Solution/ Drops · Ophthalmic | 5.12 mg/mL | $31.12 per mL | NDC details & price history |
| Solution/ Drops · Ophthalmic | 6.8 mg/mL | $1.26 each | NDC details & price history |
| Solution/ Drops · Ophthalmic | 0.5 mg/mL | $8.30 per mL | NDC details & price history |
| Solution/ Drops · Ophthalmic | 0.25 mg/mL | $6.38 per mL | NDC details & price history |
| Solution/ Drops · Ophthalmic | 3.4 mg/mL | $6.10 each | NDC details & price history |
| Solution · Ophthalmic | 6.8 mg/mL | $10.32 each | NDC details & price history |
| Solution, Gel Forming / Drops · Ophthalmic | 2.5 mg/mL | $6.38 per mL | NDC details & price history |
| Solution, Gel Forming / Drops · Ophthalmic | 5 mg/mL | $8.30 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Timolol brand names
Timolol is sold under 11 brand names in the FDA directory — Blocadren, Timoptic, Istalol, Betimol and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Timolol: manufacturers and labelers
23 companies list Timolol products with the FDA. By number of product records, the largest are Somerset Therapeutics, LLC, Bausch & Lomb Incorporated, Bausch & Lomb Americas Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Timolol drug class (RxNorm)
Timolol belongs to the beta-Adrenergic Blocker class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Timolol page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Thea Pharma Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →