Travoprost side effects: what 8,599 FDA adverse event reports show

Travoprost · Travoprost Ophthalmic Soluton · 996 reaction terms · 22,786 drug–reaction co-reports · data 2026-09-14

Drug class

Prostaglandin Analog

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Travoprost Ophthalmic Soluton

openFDA label

Who reports

8,599 reports · 37% serious · 330 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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 )

FDA label, Indications and Usage

What it is

Travoprost is a synthetic prostaglandin F analog.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 1Labeled (related wording) 5Likely indication confounding 5Reporting / coding artifact 6Lab value / disease marker 2Not in label — unassessed 21

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 956 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Vertebral end plate inflammation	13	6,252.6 2,229.5–17,535.0ROR 6,262.1 · χ² 20,868 / p <1e-300	486.8 EB05 302.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Malignant mediastinal neoplasm	42	1,553.9 1,054.8–2,289.2ROR 1,561.5 · χ² 38,657 / p <1e-300	658.9 EB05 508.0 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=42 · ♀ 100% (drug 61%)	no trial data cached
Adrenal cyst	12	303.8 166.7–553.6ROR 304.2 · χ² 2,952 / p <1e-300	189.1 EB05 115.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Eyelash thickening	10	218.6 114.5–417.5ROR 218.9 · χ² 1,791 / p <1e-300	145.5 EB05 84.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Intraocular pressure fluctuation	15	209.7 123.8–355.3ROR 210.1 · χ² 2,677 / p <1e-300	155.2 EB05 99.9 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Product dropper issue	45	145.8 108.0–196.9ROR 146.6 · χ² 5,968 / p <1e-300	130.1 EB05 101.2 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Intraocular pressure decreased	28	135.5 92.6–198.1ROR 135.9 · χ² 3,412 / p <1e-300	118.2 EB05 85.8 · IC025 +4.7 3/3 methods agree	Likely indication confounding term in indications	serious n=7	no trial data cached
Growth of eyelashes	41	132.3 96.7–181.1ROR 133.0 · χ² 4,942 / p <1e-300	118.7 EB05 91.2 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Product container seal issue	46	68.6 51.2–91.9ROR 69.0 · χ² 2,915 / p <1e-300	65.0 EB05 50.7 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious n=4 · ♀ 88% (drug 61%)	no trial data cached
Reaction to preservatives	20	61.2 39.3–95.3ROR 61.3 · χ² 1,097 / p 8e-241	56.6 EB05 38.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Open angle glaucoma	15	61.0 36.6–101.8ROR 61.1 · χ² 806 / p 1e-177	55.6 EB05 35.8 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications	serious n=14	no trial data cached
Treatment failure	1,949	59.3 57.0–61.7ROR 76.4 · χ² 109,376 / p <1e-300	57.9 EB05 55.7 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious PRR 2.0 · 79% consumer	no trial data cached
Intraocular pressure increased (raised eye pressure)	299	58.1 51.9–65.1ROR 60.2 · χ² 16,342 / p <1e-300	56.6 EB05 51.4 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 58.4	no trial data cached
Intraocular pressure test abnormal	16	56.4 34.4–92.6ROR 56.5 · χ² 798 / p 8e-176	51.9 EB05 33.9 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Bursitis infective	12	55.0 31.0–97.4ROR 55.0 · χ² 570 / p 3e-126	49.8 EB05 30.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Eye allergy	32	51.8 36.5–73.5ROR 52.0 · χ² 1,511 / p <1e-300	49.3 EB05 36.6 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious n=9	no trial data cached
Blepharal pigmentation	10	48.9 26.1–91.4ROR 48.9 · χ² 414 / p 3e-92	44.2 EB05 25.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Blood immunoglobulin e increased	44	44.8 33.3–60.3ROR 45.0 · χ² 1,808 / p <1e-300	43.3 EB05 33.6 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=44 · ♀ 100% (drug 61%)	no trial data cached
Punctate keratitis	13	36.4 21.1–63.0ROR 36.5 · χ² 407 / p 8e-91	34.3 EB05 21.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Choroidal effusion	11	34.0 18.8–61.6ROR 34.0 · χ² 316 / p 6e-71	31.8 EB05 18.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Dark circles under eyes	20	33.5 21.6–52.1ROR 33.6 · χ² 591 / p 7e-131	32.2 EB05 22.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=4 · ♀ 90% (drug 61%)	no trial data cached
Glaucoma	260	33.3 29.6–37.6ROR 34.3 · χ² 8,019 / p <1e-300	32.8 EB05 29.6 · IC025 +4.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 54.7 · 70% consumer	no trial data cached
Tongue haemorrhage	13	27.2 15.8–47.0ROR 27.2 · χ² 299 / p 3e-67	26.0 EB05 16.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Eyelid margin crusting	30	26.2 18.3–37.5ROR 26.3 · χ² 695 / p 2e-153	25.6 EB05 18.8 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Ocular hyperaemia	495	26.1 23.9–28.4ROR 27.6 · χ² 11,821 / p <1e-300	25.8 EB05 24.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 21.2 · 72% consumer	no trial data cached
Foreign body sensation in eyes	65	25.6 20.1–32.7ROR 25.8 · χ² 1,499 / p <1e-300	25.2 EB05 20.5 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious n=17	no trial data cached
Product container issue	82	23.9 19.3–29.7ROR 24.2 · χ² 1,763 / p <1e-300	23.6 EB05 19.6 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious n=8	no trial data cached
Blepharitis	35	21.8 15.6–30.4ROR 21.9 · χ² 668 / p 1e-147	21.4 EB05 16.1 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=17	no trial data cached
Eye irritation	487	21.5 19.7–23.4ROR 22.7 · χ² 9,429 / p <1e-300	21.3 EB05 19.7 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 28.5	no trial data cached
Optic nerve injury	10	21.3 11.5–39.8ROR 21.4 · χ² 173 / p 1e-39	20.0 EB05 10.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Corneal opacity	11	19.9 11.0–36.0ROR 19.9 · χ² 177 / p 9e-41	18.7 EB05 10.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Product packaging quantity issue	82	18.4 14.9–22.9ROR 18.6 · χ² 1,326 / p 1e-290	18.2 EB05 15.1 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Subacute cutaneous lupus erythematosus	13	18.1 10.5–31.2ROR 18.1 · χ² 192 / p 7e-44	17.1 EB05 10.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Ocular hypertension	14	17.9 10.6–30.3ROR 18.0 · χ² 206 / p 6e-47	17.1 EB05 10.2 · IC025 +2.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=14	no trial data cached
Ocular discomfort	78	17.6 14.1–22.0ROR 17.8 · χ² 1,199 / p 6e-263	17.4 EB05 14.4 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=18 · 78% consumer	no trial data cached
Eyelid irritation	17	16.9 10.5–27.3ROR 17.0 · χ² 238 / p 6e-54	16.2 EB05 10.3 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Joint noise	13	16.4 9.5–28.4ROR 16.5 · χ² 172 / p 1e-39	15.4 EB05 8.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=13	no trial data cached
Eyelid pain	13	16.4 9.5–28.3ROR 16.5 · χ² 172 / p 1e-39	15.4 EB05 8.8 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Eyelids pruritus	20	16.0 10.3–24.9ROR 16.1 · χ² 265 / p 7e-60	15.4 EB05 10.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Retinal disorder	17	16.0 9.9–25.8ROR 16.0 · χ² 223 / p 1e-50	15.3 EB05 9.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=15	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Treatment failure	1,949	59.3 57.0–61.7ROR 76.4 · χ² 109,376 / p <1e-300	57.9 EB05 55.7 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious PRR 2.0 · 79% consumer	no trial data cached
Drug ineffective (drug did not work)	541	1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.492	1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.2	no trial data cached
Ocular hyperaemia	495	26.1 23.9–28.4ROR 27.6 · χ² 11,821 / p <1e-300	25.8 EB05 24.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 21.2 · 72% consumer	no trial data cached
Eye irritation	487	21.5 19.7–23.4ROR 22.7 · χ² 9,429 / p <1e-300	21.3 EB05 19.7 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 28.5	no trial data cached
Eye pain	346	15.4 13.9–17.0ROR 16.0 · χ² 4,615 / p <1e-300	15.3 EB05 14.0 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.3 · 74% consumer	no trial data cached
Intraocular pressure increased (raised eye pressure)	299	58.1 51.9–65.1ROR 60.2 · χ² 16,342 / p <1e-300	56.6 EB05 51.4 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 58.4	no trial data cached
Hypersensitivity (allergic reaction)	269	3.5 3.1–4.0ROR 3.6 · χ² 492 / p 3e-109	3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 1.9 · 72% consumer	no trial data cached
Fatigue (tiredness)	265	0.8 0.7–0.9ROR 0.8 · χ² 9 / p 0.001	0.8 EB05 0.8 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.4	no trial data cached
Glaucoma	260	33.3 29.6–37.6ROR 34.3 · χ² 8,019 / p <1e-300	32.8 EB05 29.6 · IC025 +4.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 54.7 · 70% consumer	no trial data cached
Headache	236	0.9 0.8–1.0ROR 0.9 · χ² 2 / p 0.099	0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.6	no trial data cached
Dizziness	233	1.1 1.0–1.3ROR 1.1 · χ² 4 / p 0.023	1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 2.0	no trial data cached
Vision blurred (blurred vision)	229	4.1 3.6–4.7ROR 4.2 · χ² 535 / p 1e-118	4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.3 · 71% consumer	no trial data cached
Visual impairment	218	4.3 3.8–4.9ROR 4.4 · χ² 556 / p 3e-123	4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.3 · 74% consumer	no trial data cached
Death	206	0.6 0.5–0.7ROR 0.6 · χ² 64 / p 8e-16	0.6 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction	serious PRR 0.9	no trial data cached
Dyspnoea (shortness of breath)	206	0.9 0.8–1.0ROR 0.9 · χ² 3 / p 0.045	0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.6	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Malignant mediastinal neoplasm — n=42, PRR 1,553.9
Growth of eyelashes — n=41, PRR 132.3
Reaction to preservatives — n=20, PRR 61.2
Dark circles under eyes — n=20, PRR 33.5
Ocular hyperaemia — n=495, PRR 26.1
Eye irritation — n=487, PRR 21.5
Eyelids pruritus — n=20, PRR 16.0

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Travoprost?

In FDA FAERS, the most frequently co-reported reaction terms for Travoprost are ocular hyperaemia, eye irritation, eye pain, intraocular pressure increased, hypersensitivity, fatigue. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Travoprost have an FDA boxed warning?

No. The FDA label retrieved for Travoprost has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Travoprost causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 498a376e-a74e-48d8-a022-ad15a1ecadb5, effective 20250607; matched on openfda.generic_name.exact:"TRAVOPROST")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 996 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.