Tafluprost side effects: what 2,905 FDA adverse event reports show

Tafluprost · 59 reaction terms · 2,722 drug–reaction co-reports · data 2026-09-14

Drug class

Prostaglandin Analog

FDA label (Established Pharmacologic Class) · compare the class

Who reports

2,905 reports · 35% serious · 330 with death outcome · 70% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Tafluprost ophthalmic solution is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Tafluprost ophthalmic solution is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )

FDA label, Indications and Usage

What it is

Tafluprost ophthalmic solution 0.0015% contains tafluprost, a fluorinated analog of prostaglandin F2α, for topical ophthalmic use.

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 25 strongest signals

Labeled adverse reaction 6Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 1Not in label — unassessed 10

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.
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. 34 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
Ocular hyperaemia	464	72.4 66.6–78.7ROR 85.9 · χ² 32,336 / p <1e-300	71.5 EB05 66.2 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.9 · 73% consumer	no trial data cached
Eye irritation	425	55.4 50.7–60.5ROR 64.8 · χ² 22,545 / p <1e-300	54.9 EB05 50.6 · IC025 +5.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.8 · 76% consumer	no trial data cached
Intraocular pressure increased (raised eye pressure)	97	54.9 45.1–66.8ROR 56.8 · χ² 5,045 / p <1e-300	54.0 EB05 45.5 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications	serious PRR 24.5	no trial data cached
Eye pruritus	230	50.7 44.8–57.4ROR 55.0 · χ² 11,092 / p <1e-300	50.1 EB05 44.9 · IC025 +5.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.7 · 73% consumer	no trial data cached
Eye pain	293	38.5 34.5–42.9ROR 42.7 · χ² 10,630 / p <1e-300	38.2 EB05 34.7 · IC025 +5.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.4 · 75% consumer	no trial data cached
Photophobia (light sensitivity)	86	33.4 27.1–41.1ROR 34.4 · χ² 2,659 / p <1e-300	33.0 EB05 27.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.3 · 75% consumer	no trial data cached
Eye discharge	42	29.8 22.0–40.2ROR 30.2 · χ² 1,135 / p 3e-249	29.3 EB05 22.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	77% consumer	no trial data cached
Ocular discomfort	39	26.0 19.0–35.5ROR 26.3 · χ² 910 / p 4e-200	25.6 EB05 19.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=5 · 75% consumer	no trial data cached
Eye swelling	122	23.9 20.1–28.4ROR 24.9 · χ² 2,648 / p <1e-300	23.7 EB05 20.4 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.1 · 74% consumer	no trial data cached
Eye inflammation	25	19.2 13.0–28.3ROR 19.3 · χ² 412 / p 8e-92	18.8 EB05 13.3 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Lacrimation increased	74	17.9 14.3–22.4ROR 18.4 · χ² 1,164 / p 3e-255	17.8 EB05 14.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.2 · 71% consumer	no trial data cached
Dry eye	110	16.4 13.7–19.7ROR 17.0 · χ² 1,577 / p <1e-300	16.3 EB05 13.9 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.0 · 80% consumer	no trial data cached
Glaucoma	41	15.4 11.3–20.9ROR 15.6 · χ² 536 / p 6e-119	15.2 EB05 11.5 · IC025 +3.2 3/3 methods agree	Likely indication confounding term in indications	serious PRR 23.8	no trial data cached
Eyelid oedema	17	10.5 6.5–16.9ROR 10.5 · χ² 137 / p 8e-32	9.3 EB05 5.8 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Vision blurred (blurred vision)	174	9.2 8.0–10.6ROR 9.7 · χ² 1,270 / p 2e-278	9.1 EB05 8.0 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.5 · 75% consumer	no trial data cached
Eye infection	12	7.7 4.4–13.6ROR 7.8 · χ² 64 / p 7e-16	6.3 EB05 3.7 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Eye haemorrhage	14	7.6 4.5–12.8ROR 7.6 · χ² 73 / p 6e-18	6.3 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Incorrect product storage	13	7.0 4.1–12.1ROR 7.1 · χ² 61 / p 2e-15	5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Visual acuity reduced	26	5.6 3.8–8.2ROR 5.6 · χ² 94 / p 2e-22	5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Uveitis	10	5.3 2.9–9.9ROR 5.4 · χ² 31 / p 1e-8	4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.5	no trial data cached
Conjunctivitis	10	3.9 2.1–7.3ROR 3.9 · χ² 19 / p 7e-6	3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.6	no trial data cached
Blindness	18	3.2 2.0–5.1ROR 3.2 · χ² 25 / p 3e-7	3.0 EB05 2.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	no trial data cached
Cataract	26	3.2 2.2–4.6ROR 3.2 · χ² 36 / p 8e-10	3.0 EB05 2.2 · IC025 +0.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.7	no trial data cached
Visual impairment	50	2.9 2.2–3.9ROR 3.0 · χ² 62 / p 2e-15	2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	no trial data cached
Eye disorder	13	2.9 1.7–4.9ROR 2.9 · χ² 14 / p 9e-5	2.7 EB05 1.7 · IC025 +0.5	Labeled adverse reaction exact term	serious PRR 6.1	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
Ocular hyperaemia	464	72.4 66.6–78.7ROR 85.9 · χ² 32,336 / p <1e-300	71.5 EB05 66.2 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.9 · 73% consumer	no trial data cached
Eye irritation	425	55.4 50.7–60.5ROR 64.8 · χ² 22,545 / p <1e-300	54.9 EB05 50.6 · IC025 +5.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.8 · 76% consumer	no trial data cached
Eye pain	293	38.5 34.5–42.9ROR 42.7 · χ² 10,630 / p <1e-300	38.2 EB05 34.7 · IC025 +5.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.4 · 75% consumer	no trial data cached
Eye pruritus	230	50.7 44.8–57.4ROR 55.0 · χ² 11,092 / p <1e-300	50.1 EB05 44.9 · IC025 +5.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.7 · 73% consumer	no trial data cached
Vision blurred (blurred vision)	174	9.2 8.0–10.6ROR 9.7 · χ² 1,270 / p 2e-278	9.1 EB05 8.0 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.5 · 75% consumer	no trial data cached
Eye swelling	122	23.9 20.1–28.4ROR 24.9 · χ² 2,648 / p <1e-300	23.7 EB05 20.4 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.1 · 74% consumer	no trial data cached
Dry eye	110	16.4 13.7–19.7ROR 17.0 · χ² 1,577 / p <1e-300	16.3 EB05 13.9 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.0 · 80% consumer	no trial data cached
Intraocular pressure increased (raised eye pressure)	97	54.9 45.1–66.8ROR 56.8 · χ² 5,045 / p <1e-300	54.0 EB05 45.5 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications	serious PRR 24.5	no trial data cached
Photophobia (light sensitivity)	86	33.4 27.1–41.1ROR 34.4 · χ² 2,659 / p <1e-300	33.0 EB05 27.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.3 · 75% consumer	no trial data cached
Lacrimation increased	74	17.9 14.3–22.4ROR 18.4 · χ² 1,164 / p 3e-255	17.8 EB05 14.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.2 · 71% consumer	no trial data cached
Visual impairment	50	2.9 2.2–3.9ROR 3.0 · χ² 62 / p 2e-15	2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	no trial data cached
Eye discharge	42	29.8 22.0–40.2ROR 30.2 · χ² 1,135 / p 3e-249	29.3 EB05 22.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	77% consumer	no trial data cached
Glaucoma	41	15.4 11.3–20.9ROR 15.6 · χ² 536 / p 6e-119	15.2 EB05 11.5 · IC025 +3.2 3/3 methods agree	Likely indication confounding term in indications	serious PRR 23.8	no trial data cached
Ocular discomfort	39	26.0 19.0–35.5ROR 26.3 · χ² 910 / p 4e-200	25.6 EB05 19.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=5 · 75% consumer	no trial data cached
Product quality issue	35	1.9 1.3–2.6ROR 1.9 · χ² 13 / p 1e-4	1.9 EB05 1.4 · IC025 +0.3	Reporting / coding artifact	serious PRR 2.2	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.

Ocular hyperaemia — n=464, PRR 72.4
Photophobia — n=86, PRR 33.4
Eye discharge — n=42, PRR 29.8
Ocular discomfort — n=39, PRR 26.0
Eye swelling — n=122, PRR 23.9
Lacrimation increased — n=74, PRR 17.9
Visual acuity reduced — n=26, PRR 5.6
Visual impairment — n=50, PRR 2.9

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 Tafluprost?

In FDA FAERS, the most frequently co-reported reaction terms for Tafluprost are ocular hyperaemia, eye irritation, eye pain, eye pruritus, vision blurred, eye swelling. 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 Tafluprost have an FDA boxed warning?

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

Do FAERS signals prove that Tafluprost 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 bfffa484-4105-45ec-ab1d-124e96639f35, effective 20260815; matched on openfda.generic_name.exact:"TAFLUPROST")
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, 59 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.