Drug · FAERS side-effect profile with label screen
Travoprost (Isomer Free) side effects: what 3,160 FDA adverse event reports show
Brand names
Travoprost
openFDA label
Who reports
3,160 reports · 47% serious · 109 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Travoprost ophthalmic 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 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 4Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 23
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. 38 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Treatment failure | 893 | 72.9 69.0–77.1ROR 101.3 · χ² 62,838 / p <1e-300 | 72.0 EB05 68.2 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · 79% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 84 | 43.7 35.3–54.0ROR 44.8 · χ² 3,438 / p <1e-300 | 43.0 EB05 35.8 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 44.1 | no trial data cached |
| Full blood count abnormal | 42 | 26.5 19.6–35.8ROR 26.9 · χ² 1,002 / p 3e-220 | 26.1 EB05 20.2 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 43.1 · ♀ 100% (drug 57%) | no trial data cached |
| Product packaging quantity issue | 29 | 17.7 12.3–25.4ROR 17.8 · χ² 438 / p 1e-97 | 17.4 EB05 12.6 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Eye irritation | 122 | 14.5 12.2–17.3ROR 15.1 · χ² 1,526 / p <1e-300 | 14.5 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · 72% consumer | no trial data cached |
| Glaucoma | 41 | 14.1 10.4–19.2ROR 14.3 · χ² 487 / p 3e-108 | 13.9 EB05 10.5 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 18.2 | no trial data cached |
| Ocular discomfort | 23 | 14.1 9.4–21.2ROR 14.2 · χ² 266 / p 4e-60 | 13.5 EB05 9.1 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=10 · ♀ 86% (drug 57%) · 90% consumer | no trial data cached |
| Ocular hyperaemia | 83 | 11.8 9.5–14.6ROR 12.1 · χ² 810 / p 2e-178 | 11.6 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 | no trial data cached |
| Eye pain | 90 | 10.8 8.8–13.3ROR 11.1 · χ² 793 / p 7e-175 | 10.6 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.2 · 76% consumer | no trial data cached |
| Intervertebral disc degeneration | 15 | 10.7 6.5–17.7ROR 10.7 · χ² 122 / p 1e-28 | 9.3 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 | no trial data cached |
| Eye discharge | 16 | 10.4 6.4–17.0ROR 10.4 · χ² 127 / p 1e-29 | 9.1 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Eye pruritus | 51 | 10.3 7.8–13.5ROR 10.4 · χ² 418 / p 4e-93 | 9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.8 | no trial data cached |
| Retinal detachment | 12 | 8.7 4.9–15.2ROR 8.7 · χ² 74 / p 4e-18 | 7.0 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Oesophagitis | 13 | 7.9 4.6–13.6ROR 7.9 · χ² 71 / p 1e-17 | 6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Eye inflammation | 11 | 7.7 4.3–14.0ROR 7.8 · χ² 58 / p 1e-14 | 6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious n=6 | no trial data cached |
| Neoplasm | 13 | 7.5 4.4–12.9ROR 7.5 · χ² 67 / p 2e-16 | 6.2 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Musculoskeletal chest pain | 15 | 6.4 3.9–10.6ROR 6.5 · χ² 63 / p 8e-16 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Rhinorrhoea (runny nose) | 60 | 6.2 4.8–7.9ROR 6.3 · χ² 256 / p 7e-58 | 5.9 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · ♀ 78% (drug 57%) | no trial data cached |
| Wheezing | 51 | 5.7 4.4–7.5ROR 5.8 · χ² 194 / p 2e-44 | 5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 94% (drug 57%) | no trial data cached |
| Nasal congestion (stuffy nose) | 48 | 5.4 4.1–7.2ROR 5.5 · χ² 170 / p 4e-39 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · ♀ 98% (drug 57%) | no trial data cached |
| Eye disorder | 24 | 4.9 3.3–7.2ROR 4.9 · χ² 70 / p 3e-17 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Blood pressure systolic increased | 14 | 4.7 2.8–8.0ROR 4.8 · χ² 38 / p 4e-10 | 4.2 EB05 2.6 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 6.4 | no trial data cached |
| Photophobia (light sensitivity) | 12 | 4.3 2.4–7.5ROR 4.3 · χ² 27 / p 1e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Hyponatraemia (low sodium) | 36 | 4.2 3.1–5.9ROR 4.3 · χ² 86 / p 7e-21 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 88% (drug 57%) · 100% clinician | no trial data cached |
| Basal cell carcinoma | 10 | 4.2 2.3–7.9ROR 4.3 · χ² 22 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Lacrimation increased | 19 | 4.2 2.7–6.6ROR 4.2 · χ² 44 / p 2e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Pain in jaw | 17 | 4.0 2.5–6.4ROR 4.0 · χ² 35 / p 2e-9 | 3.6 EB05 2.4 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 | no trial data cached |
| Dry eye | 29 | 4.0 2.8–5.7ROR 4.0 · χ² 62 / p 2e-15 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 75% consumer | no trial data cached |
| Heart rate decreased | 21 | 3.9 2.6–6.0ROR 4.0 · χ² 43 / p 2e-11 | 3.7 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 28 | 3.8 2.6–5.5ROR 3.9 · χ² 56 / p 4e-14 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 85% (drug 57%) | no trial data cached |
| Frequent bowel movements | 15 | 3.7 2.2–6.1ROR 3.7 · χ² 27 / p 1e-7 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Conjunctivitis | 10 | 3.6 1.9–6.7ROR 3.6 · χ² 16 / p 3e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 7.4 | no trial data cached |
| Product substitution issue | 31 | 3.6 2.5–5.1ROR 3.6 · χ² 55 / p 6e-14 | 3.4 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 79% consumer | no trial data cached |
| Eye swelling | 19 | 3.4 2.2–5.3ROR 3.4 · χ² 30 / p 2e-8 | 3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Visual acuity reduced | 17 | 3.4 2.1–5.4ROR 3.4 · χ² 26 / p 2e-7 | 3.1 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Extra dose administered | 20 | 3.3 2.1–5.1ROR 3.3 · χ² 30 / p 2e-8 | 3.1 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | 95% consumer | no trial data cached |
| Coronary artery disease | 15 | 3.3 2.0–5.4ROR 3.3 · χ² 21 / p 2e-6 | 3.0 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Cataract | 29 | 3.2 2.3–4.7ROR 3.3 · χ² 43 / p 3e-11 | 3.1 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Hyperkalaemia (high potassium) | 17 | 3.2 2.0–5.2ROR 3.2 · χ² 24 / p 5e-7 | 3.0 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Hypersensitivity (allergic reaction) | 90 | 3.2 2.6–3.9ROR 3.3 · χ² 137 / p 7e-32 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 · 71% consumer | 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 | 893 | 72.9 69.0–77.1ROR 101.3 · χ² 62,838 / p <1e-300 | 72.0 EB05 68.2 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · 79% consumer | no trial data cached |
| Eye irritation | 122 | 14.5 12.2–17.3ROR 15.1 · χ² 1,526 / p <1e-300 | 14.5 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · 72% consumer | no trial data cached |
| Product dose omission issue | 101 | 2.4 1.9–2.9ROR 2.4 · χ² 78 / p 5e-19 | 2.3 EB05 2.0 · IC025 +0.9 | Reporting / coding artifact | serious PRR 1.9 · 83% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 90 | 3.2 2.6–3.9ROR 3.3 · χ² 137 / p 7e-32 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 · 71% consumer | no trial data cached |
| Eye pain | 90 | 10.8 8.8–13.3ROR 11.1 · χ² 793 / p 7e-175 | 10.6 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.2 · 76% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 84 | 43.7 35.3–54.0ROR 44.8 · χ² 3,438 / p <1e-300 | 43.0 EB05 35.8 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 44.1 | no trial data cached |
| Ocular hyperaemia | 83 | 11.8 9.5–14.6ROR 12.1 · χ² 810 / p 2e-178 | 11.6 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 | no trial data cached |
| Vision blurred (blurred vision) | 64 | 3.1 2.4–4.0ROR 3.2 · χ² 90 / p 1e-21 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 · 81% consumer | no trial data cached |
| Rhinorrhoea (runny nose) | 60 | 6.2 4.8–7.9ROR 6.3 · χ² 256 / p 7e-58 | 5.9 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · ♀ 78% (drug 57%) | no trial data cached |
| Wheezing | 51 | 5.7 4.4–7.5ROR 5.8 · χ² 194 / p 2e-44 | 5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 94% (drug 57%) | no trial data cached |
| Eye pruritus | 51 | 10.3 7.8–13.5ROR 10.4 · χ² 418 / p 4e-93 | 9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.8 | no trial data cached |
| Asthma | 50 | 3.0 2.2–3.9ROR 3.0 · χ² 63 / p 9e-16 | 2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 94% (drug 57%) | no trial data cached |
| Nasal congestion (stuffy nose) | 48 | 5.4 4.1–7.2ROR 5.5 · χ² 170 / p 4e-39 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · ♀ 98% (drug 57%) | no trial data cached |
| Full blood count abnormal | 42 | 26.5 19.6–35.8ROR 26.9 · χ² 1,002 / p 3e-220 | 26.1 EB05 20.2 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 43.1 · ♀ 100% (drug 57%) | no trial data cached |
| Glaucoma | 41 | 14.1 10.4–19.2ROR 14.3 · χ² 487 / p 3e-108 | 13.9 EB05 10.5 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 18.2 | 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.
- Eye irritation — n=122, PRR 14.5
- Ocular hyperaemia — n=83, PRR 11.8
- Rhinorrhoea — n=60, PRR 6.2
- Wheezing — n=51, PRR 5.7
- Nasal congestion — n=48, PRR 5.4
- Eye disorder — n=24, PRR 4.9
- Hyponatraemia — n=36, PRR 4.2
- Hypoglycaemia — n=28, PRR 3.8
- Extra dose administered — n=20, PRR 3.3
- Hypersensitivity — n=90, PRR 3.2
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 (Isomer Free)?
In FDA FAERS, the most frequently co-reported reaction terms for Travoprost (Isomer Free) are eye irritation, hypersensitivity, eye pain, intraocular pressure increased, ocular hyperaemia, vision blurred. 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 (Isomer Free) have an FDA boxed warning?
No. The FDA label retrieved for Travoprost (Isomer Free) has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Travoprost (Isomer Free) 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 e9dd2388-afd3-4f40-b35d-54df8c239d29, effective 20241010; matched on
openfda.generic_name.exact:"TRAVOPROST (ISOMER FREE)") - 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, fieldpatient.drug.openfda.generic_name.exact, 78 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.