tafluprost
Pharmaranks rates Tafluprost 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Tafluprost is a prostaglandin analog used to treat Open-Angle Glaucoma.
Prostaglandin Analog · by Micro Labs
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Tafluprost
- Drug class
- Prostaglandin Analog
- Form
- Drops
- Strength
- Tafluprost 0.0015%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- open-angle glaucoma
- Manufacturer
- Micro Labs
- What the pharmacy pays
- ~$84.53 for 30 — not your price
- FDA application
- ANDA209051
What is Tafluprost?
From the FDA label:Tafluprost ophthalmic solution 0.0015% contains tafluprost, a fluorinated analog of prostaglandin F2α, for topical ophthalmic use. The chemical name for tafluprost is 1-methylethyl (5 Z )-7-{(1 R ,2 R ,3 R ,5 S )-2-[(1 E )-3,3-difluoro-4-phenoxy-1-butenyl}-3,5-dihydroxycyclopentyl]-5-heptenoate. The molecular formula of tafluprost is C 25 H 34 F 2 O 5 and its molecular weight is 452.53. Its structural formula is: Tafluprost is a colorless to light yellow viscous liquid that is practically insoluble in water. Tafluprost ophthalmic solution is supplied as a sterile solution with a pH range of 5.5 to 6.7 and an Osmolality range of 260 to 300 mOsmol/kg. Tafluprost ophthalmic solution contains Active: tafluprost 0.015 mg/mL; Inactives: edetate disodium, glycerin, monobasic sodium phosphate dihydrate, polysorbate 80, hydrochloric acid and sodium hydroxide (to adjust pH) and water for injection. Tafluprost ophthalmic solution does not contain a preservative. tafluprost-str.jpg
How to use
Apply one drop in the affected eye(s) once daily in the evening. ( 2 ) 2.1 Recommended Dosage The recommended dosage is one drop in the conjunctival sac of the affected eye(s) once daily in the evening. 2.2 Administration Instructions Tafluprost ophthalmic solution should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure (IOP) lowering effect. Reduction of the intraocular pressure starts approximately 2 to 4 hours after the first administration with the maximum effect reached after 12 hours. Tafluprost ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart. The solution from one single-dose container is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the single-dose container is opened, discard the open single-dose container and the remaining contents immediately after administration.
Side effects
Most common ocular adverse reaction is conjunctival hyperemia (4% to 20%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc., at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Preservative-containing or nonpreserved tafluprost 0.0015% was evaluated in 905 patients in five controlled clinical studies of up to 24-months duration. The most common adverse reaction observed in patients treated with tafluprost was conjunctival hyperemia which was reported in a range of 4% to 20% of patients. Approximately 1% of patients discontinued therapy due to ocular adverse reactions. Ocular adverse reactions reported at an incidence of ≥ 2% in these clinical studies included ocular stinging/irritation (7%), ocular pruritus including allergic conjunctivitis (5%), cataract (3%), dry eye (3%), ocular pain (3%), eyelash darkening (2%), growth of eyelashes (2%) and vision blurred (2%). Nonocular adverse reactions reported at an incidence of 2% to 6% in these clinical studies in patients treated with tafluprost 0.0015% were headache (6%), common cold (4%), cough (3%)…
Warnings
Important safety information
Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation is likely to be permanent. ( 5.1 ) Eyelash Changes: Gradual changes to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.2 ) 5.1 Pigmentation Tafluprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as tafluprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of tafluprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with tafluprost ophthalmic solution can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. 5.2 Eyelash Changes Tafluprost may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, color, thickness, shape and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. 5.3 Intraocular Inflammation Tafluprost should be used with caution in patients with active intraocular inflammation (e.g., iritis/uveitis) because the inflammation may be exacerbated. 5.4 Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2α analogs. Tafluprost should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. 5.5 Contact Lens Use Contact lenses should be removed prior to the administration of tafluprost ophthalmic solution and may be reinserted 15 minutes after administration.
Who should not take Tafluprost
None. None. ( 4 )
Storing Tafluprost, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Discard any unused containers 30 days after first opening the pouch.”
- “Discard any unopened containers 30 days after first opening the pouch.”
Drug class
How this class works, per Latanoprost - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Tafluprost ranks — best-rated prostaglandin analog for:
Dosage forms
Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Tafluprost treat?
- Tafluprost (Tafluprost) may be used to treat open-angle glaucoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Tafluprost work?
- Tafluprost is a prostaglandin analog. Prostaglandin analogs (used as eye drops for glaucoma) activate FP receptors that relax the eye's drainage tissues, helping fluid flow out more easily. This lowers the pressure inside the eye and protects the optic nerve.
- How is Tafluprost rated?
- pharmaranks gives Tafluprost a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Tafluprost cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $84.53 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Tafluprost?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tafluprost. To pay less, Tafluprost is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Tafluprost?
- Tafluprost is marketed by Micro Labs. You can see Micro Labs's full profile, rating, and other products on pharmaranks.
- Is Tafluprost a brand-name or generic drug?
- Tafluprost is a generic medication; its active ingredient is Tafluprost. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Tafluprost available over the counter?
- No. Tafluprost is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Tafluprost come in?
- Tafluprost is currently marketed as drops, per the FDA's National Drug Code Directory.
- What class of drug is Tafluprost?
- Tafluprost is classified as prostaglandin analog, per the FDA's Established Pharmacologic Class.
- Is Tafluprost FDA-registered?
- Tafluprost is on record with the U.S. FDA under application number ANDA209051. You can verify this on its official FDA label.
- Has Tafluprost been recalled by the FDA?
- Tafluprost has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Tafluprost safe?
- There's no single safe-or-not verdict. pharmaranks gives Tafluprost a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Tafluprost?
- Tafluprost's side effects are taken directly from its FDA label. From the label: Most common ocular adverse reaction is conjunctival hyperemia (4% to 20%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc., at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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