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travoprost

Sold as iDose, Travatan. Class: Prostaglandin analogues. First FDA approval 03/16/2001: 25 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

B

Score breakdown (79/100)

Safety ×35%
A
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
C
Options ×10%
A

Safety: 100

Evidence: 40

Regulatory history: 93

Money & lawsuits: 70

Options: 100

What the FDA label says

Approved uses

Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Travoprost ophthalmic solution (ionic buffered solution) is a prostaglandin analog indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )

Contraindications

None. None ( 4 )

Warnings and precautions

• Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid), and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.1 ) • Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.2 ) 5.1 Pigmentation Travoprost 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 travoprost 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 travoprost, 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 aroun...

Adverse reactions (label)

Most common adverse reaction (30% to 50%) is conjunctival hyperemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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 trials 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. The most common adverse reaction observed in controlled clinical trials with travoprost ophthalmic solution 0.004% was ocular hyperemia, which was reported in 30% to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5% to 10% in these clinical trials included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. Ocular adverse reactions reported at an incidence of 1% to 4% in clinical trials with travoprost ophthalmic solution 0.004% included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloratio...

Source: FDA SPL label for Travoprost Ophthalmic Solution, 0.004% (Mylan Pharmaceuticals Inc.), effective 20260115. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

11,465reports that mention this drug
11,460of those blame this drug, not another one the person was taking
40%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
4.8%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Treatment Failure · 2,391Drug Ineffective · 741Ocular Hyperaemia · 593Eye Irritation · 589Intraocular Pressure Increased · 444Eye Pain · 427Glaucoma · 380Hypersensitivity · 372Fatigue · 358Dyspnoea · 351Visual Impairment · 351Dizziness · 306Headache · 303Vision Blurred · 302Death · 296

Reports per year

20192020202120222023202420252026
1,1293,373651446352319406234

1,923 reports blaming this drug for every million Medicare prescriptions filled, which is 0.7× the typical drug on this site. (957 reports in 2024–2026, against 497,738 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

1recall actions on file
4 / 9brand / generic applications
3label changes since 2021
NoREMS program
DateClassFirmReason
05/2023Class IIGolden State Medical Supply Inc.Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.

Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.

Evidence base

101randomized trials (PubMed)
2systematic reviews
158registered trials
46%of completed trials posted results
11%terminated or withdrawn
79%industry-funded

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $1,404,659 in payments to US physicians and hospitals tied to this drug across 4,091 transactions (iDose $1,404,659).

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

122,995Medicare Part D patients (2024)
497,738prescriptions filled
$172average cost per fill
$86Mtotal Medicare spend
ProductFills$/fill
Travoprost476,526$158
Travatan Z21,212$499

Same-class alternatives

latanoprostene bunodtafluprostunoprostone

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. The most-reported problems in FDA's adverse event data are treatment failure, ocular hyperaemia, eye irritation. How would we recognize and handle those?
  2. Why this one over bimatoprost, latanoprost, latanoprostene bunod? What would make you pick one of those instead?
  3. The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
  4. What result are we expecting, by when, and what is the plan if it does not happen?
  5. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)