Drug · FAERS side-effect profile with label screen
Latanoprost side effects: what 50,007 FDA adverse event reports show
Who reports
50,007 reports · 55% serious · 3,179 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )
FDA label, Indications and Usage
What it is
Latanoprost is a prostaglandin F 2α analogue.
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 3Labeled (related wording) 4Likely indication confounding 5Reporting / coding artifact 4Lab value / disease marker 1Not 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,156 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 |
|---|---|---|---|---|---|---|
| Eyelash thickening | 29 | 131.5 86.6–199.7ROR 131.6 · calibrated p 5e-8 ✓ | 93.9 EB05 68.6 · IC025 +4.6 3/3 methods agree vs other Prostaglandin Analogs: PRR 10.1 (6.2–16.5) | Not in label — unassessed | ♀ 100% (drug 61%) | not reported in cached trials |
| Intraocular pressure fluctuation | 41 | 115.9 82.0–163.8ROR 116.0 · calibrated p 9e-8 ✓ | 87.1 EB05 67.0 · IC025 +4.9 3/3 methods agree vs other Prostaglandin Analogs: PRR 13.5 (8.6–21.0) | Lab value / disease marker | serious n=27 | not reported in cached trials |
| Intraocular pressure test abnormal | 127 | 91.8 75.7–111.2ROR 92.0 · calibrated p 3e-7 ✓ | 74.5 EB05 64.2 · IC025 +5.6 3/3 methods agree vs other Prostaglandin Analogs: PRR 31.5 (22.7–43.8) | Reporting / coding artifact | serious n=89 · 70% consumer | not reported in cached trials |
| Glaucoma surgery | 45 | 89.7 65.0–123.8ROR 89.8 · calibrated p 5e-7 ✓ | 71.7 EB05 55.8 · IC025 +4.9 3/3 methods agree vs other Prostaglandin Analogs: PRR 45.6 (24.1–86.2) | Likely indication confounding shares a disease stem with the indications wording | serious n=45 · 70% consumer | not reported in cached trials |
| Iris hyperpigmentation | 36 | 87.9 61.3–126.0ROR 88.0 · calibrated p 7e-7 ✓ | 70.1 EB05 52.9 · IC025 +4.6 3/3 methods agree vs other Prostaglandin Analogs: PRR 4.2 (2.9–6.1) | Not in label — unassessed | ♀ 100% (drug 61%) | not reported in cached trials |
| Product closure removal difficult | 164 | 82.0 69.4–97.0ROR 82.3 · calibrated p 6e-7 ✓ | 68.1 EB05 59.8 · IC025 +5.6 3/3 methods agree vs other Prostaglandin Analogs: only this drug | Reporting / coding artifact | ♀ 83% (drug 61%) · 100% consumer | not reported in cached trials |
| Steroid dependence | 139 | 81.9 68.3–98.3ROR 82.2 · calibrated p 6e-7 ✓ | 67.9 EB05 59.0 · IC025 +5.5 3/3 methods agree vs other Prostaglandin Analogs: only this drug | Not in label — unassessed | serious n=139 · ♀ 15% (drug 61%) · 92% clinician | not reported in cached trials |
| Catarrh | 138 | 77.0 64.2–92.3ROR 77.2 · calibrated p 9e-7 ✓ | 64.5 EB05 55.9 · IC025 +5.4 3/3 methods agree vs other Prostaglandin Analogs: only this drug | Not in label — unassessed | serious n=138 · ♀ 16% (drug 61%) · 93% clinician | not reported in cached trials |
| Growth of eyelashes | 113 | 69.3 56.8–84.5ROR 69.4 · calibrated p 2e-6 ✓ | 58.9 EB05 50.3 · IC025 +5.3 3/3 methods agree vs other Prostaglandin Analogs: PRR 4.1 (3.3–5.0) | Labeled adverse reaction exact term | serious n=44 · 75% consumer | not reported in cached trials |
| Intraocular pressure increased (raised eye pressure) | 1,786 | 67.7 64.4–71.1ROR 70.2 · calibrated p 1e-6 ✓ | 58.3 EB05 56.0 · IC025 +5.8 3/3 methods agree vs other Prostaglandin Analogs: PRR 17.9 (16.7–19.3) | Likely indication confounding term in indications | serious PRR 65.8 | not reported in cached trials |
| Product dropper issue | 94 | 56.0 45.1–69.4ROR 56.1 · calibrated p 8e-6 ✓ | 48.9 EB05 41.2 · IC025 +5.0 3/3 methods agree vs other Prostaglandin Analogs: PRR 14.1 (10.5–19.0) | Reporting / coding artifact | serious n=32 | not reported in cached trials |
| Ocular surface disease | 30 | 53.6 36.6–78.4ROR 53.6 · calibrated p 2e-5 ✓ | 46.2 EB05 34.0 · IC025 +4.1 3/3 methods agree vs other Prostaglandin Analogs: PRR 14.6 (8.6–24.8) | Labeled (related wording) related wording | serious n=30 · 100% clinician | not reported in cached trials |
| Intraocular pressure decreased | 54 | 47.3 35.7–62.7ROR 47.4 · calibrated p 3e-5 ✓ | 42.0 EB05 33.4 · IC025 +4.5 3/3 methods agree vs other Prostaglandin Analogs: PRR 10.8 (7.5–15.5) | Likely indication confounding term in indications | serious n=34 | not reported in cached trials |
| Reaction to preservatives | 74 | 41.7 32.9–53.0ROR 41.8 · calibrated p 5e-5 ✓ | 37.6 EB05 31.0 · IC025 +4.5 3/3 methods agree vs other Prostaglandin Analogs: PRR 17.3 (12.1–24.7) | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Hypotony of eye | 37 | 40.6 29.0–56.9ROR 40.6 · calibrated p 7e-5 ✓ | 36.4 EB05 27.6 · IC025 +4.1 3/3 methods agree vs other Prostaglandin Analogs: PRR 50.0 (24.1–103.6) | Not in label — unassessed | serious n=37 · ♀ 41% (drug 61%) · 100% clinician | not reported in cached trials |
| Burns second degree | 147 | 38.4 32.4–45.5ROR 38.5 · calibrated p 7e-5 ✓ | 35.1 EB05 30.6 · IC025 +4.7 3/3 methods agree vs other Prostaglandin Analogs: only this drug | Not in label — unassessed | serious n=147 · ♀ 19% (drug 61%) · 92% clinician | not reported in cached trials |
| Open angle glaucoma | 47 | 34.7 25.8–46.7ROR 34.7 · calibrated p 2e-4 ✓ | 31.7 EB05 24.8 · IC025 +4.1 3/3 methods agree vs other Prostaglandin Analogs: PRR 13.0 (8.6–19.6) | Likely indication confounding term in indications | serious n=46 | not reported in cached trials |
| Choroidal detachment | 42 | 34.3 25.1–47.0ROR 34.3 · calibrated p 2e-4 ✓ | 31.4 EB05 24.2 · IC025 +4.0 3/3 methods agree vs other Prostaglandin Analogs: PRR 18.9 (11.7–30.7) | Not in label — unassessed | serious n=41 · 100% clinician | not reported in cached trials |
| Eye laser surgery | 43 | 32.9 24.1–44.9ROR 32.9 · calibrated p 2e-4 ✓ | 30.2 EB05 23.4 · IC025 +4.0 3/3 methods agree vs other Prostaglandin Analogs: PRR 47.5 (24.5–92.2) | Not in label — unassessed | serious n=40 · 100% consumer | not reported in cached trials |
| Treatment failure | 5,926 | 32.6 31.8–33.4ROR 36.8 · calibrated p 8e-5 ✓ | 30.3 EB05 29.6 · IC025 +4.9 3/3 methods agree vs other Prostaglandin Analogs: PRR 12.2 (11.8–12.6) | Reporting / coding artifact | serious PRR 1.6 · 76% consumer | not reported in cached trials |
| Glaucoma | 1,363 | 31.9 30.2–33.6ROR 32.7 · calibrated p 2e-4 ✓ | 29.6 EB05 28.3 · IC025 +4.8 3/3 methods agree vs other Prostaglandin Analogs: PRR 23.6 (21.6–25.8) | Likely indication confounding term in indications | serious PRR 31.8 | not reported in cached trials |
| Hyphaema | 31 | 26.3 18.3–37.8ROR 26.3 · calibrated p 8e-4 ✓ | 24.4 EB05 18.0 · IC025 +3.6 3/3 methods agree vs other Prostaglandin Analogs: PRR 26.9 (14.3–50.6) | Not in label — unassessed | serious n=29 · 100% clinician | not reported in cached trials |
| Blepharal pigmentation | 29 | 25.3 17.4–36.8ROR 25.3 · calibrated p 9e-4 ✓ | 23.6 EB05 17.2 · IC025 +3.5 3/3 methods agree vs other Prostaglandin Analogs: PRR 1.2 (0.8–1.8) | Not in label — unassessed | ♀ 100% (drug 61%) | not reported in cached trials |
| Eye burns | 32 | 23.7 16.6–33.9ROR 23.7 · calibrated p 0.001 ✓ | 22.2 EB05 16.5 · IC025 +3.5 3/3 methods agree vs other Prostaglandin Analogs: PRR 43.2 (20.6–90.6) | Not in label — unassessed | serious n=23 · ♀ 100% (drug 61%) | not reported in cached trials |
| Foreign body sensation in eyes | 326 | 23.1 20.6–25.8ROR 23.2 · calibrated p 0.001 ✓ | 21.9 EB05 19.9 · IC025 +4.2 3/3 methods agree vs other Prostaglandin Analogs: PRR 14.2 (12.1–16.6) | Labeled (related wording) related wording | serious n=114 · 71% consumer | not reported in cached trials |
| Choroidal effusion | 41 | 22.6 16.5–31.0ROR 22.6 · calibrated p 0.001 ✓ | 21.3 EB05 16.4 · IC025 +3.6 3/3 methods agree vs other Prostaglandin Analogs: PRR 24.9 (14.6–42.5) | Not in label — unassessed | serious n=39 · 100% clinician | not reported in cached trials |
| Eye colour change | 50 | 21.8 16.4–28.9ROR 21.8 · calibrated p 0.002 ✓ | 20.6 EB05 16.2 · IC025 +3.6 3/3 methods agree vs other Prostaglandin Analogs: PRR 7.6 (5.3–10.8) | Not in label — unassessed | ♀ 84% (drug 61%) · 74% consumer | not reported in cached trials |
| Instillation site erythema | 26 | 21.5 14.5–31.9ROR 21.5 · calibrated p 0.002 ✓ | 20.2 EB05 14.4 · IC025 +3.2 3/3 methods agree vs other Prostaglandin Analogs: PRR 79.0 (27.6–226.5) | Not in label — unassessed | – | not reported in cached trials |
| Corneal disorder | 99 | 20.0 16.3–24.4ROR 20.0 · calibrated p 0.002 ✓ | 19.0 EB05 16.1 · IC025 +3.8 3/3 methods agree vs other Prostaglandin Analogs: PRR 31.7 (21.8–46.0) | Labeled (related wording) related wording | serious n=90 | not reported in cached trials |
| Corneal opacity | 60 | 19.3 14.9–25.0ROR 19.3 · calibrated p 0.003 ✓ | 18.4 EB05 14.8 · IC025 +3.6 3/3 methods agree vs other Prostaglandin Analogs: PRR 14.9 (10.2–21.7) | Not in label — unassessed | serious n=58 | not reported in cached trials |
| Hypopnoea | 152 | 19.2 16.3–22.6ROR 19.3 · calibrated p 0.002 ✓ | 18.4 EB05 16.0 · IC025 +3.9 3/3 methods agree vs other Prostaglandin Analogs: PRR 616.2 (196.5–1,931.7) | Not in label — unassessed | serious n=150 · ♀ 17% (drug 61%) | not reported in cached trials |
| Eye irritation | 2,250 | 17.6 16.9–18.3ROR 18.4 · calibrated p 0.003 ✓ | 16.9 EB05 16.3 · IC025 +4.0 3/3 methods agree vs other Prostaglandin Analogs: PRR 9.4 (8.9–9.9) | Not in label — unassessed | serious PRR 25.5 | not reported in cached trials |
| Dark circles under eyes | 59 | 17.5 13.5–22.6ROR 17.5 · calibrated p 0.004 ✓ | 16.7 EB05 13.4 · IC025 +3.5 3/3 methods agree vs other Prostaglandin Analogs: PRR 7.2 (5.3–10.0) | Not in label — unassessed | ♀ 100% (drug 61%) · 100% consumer | not reported in cached trials |
| Epidermal necrosis | 39 | 17.3 12.6–23.8ROR 17.3 · calibrated p 0.005 ✓ | 16.5 EB05 12.5 · IC025 +3.3 3/3 methods agree vs other Prostaglandin Analogs: only this drug | Not in label — unassessed | serious n=39 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Corneal deposits | 29 | 17.1 11.8–24.9ROR 17.2 · calibrated p 0.005 ✓ | 16.2 EB05 11.7 · IC025 +3.1 3/3 methods agree vs other Prostaglandin Analogs: only this drug | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Eye allergy | 58 | 16.4 12.6–21.3ROR 16.4 · calibrated p 0.005 ✓ | 15.7 EB05 12.5 · IC025 +3.4 3/3 methods agree vs other Prostaglandin Analogs: PRR 10.1 (7.1–14.3) | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Corneal oedema | 83 | 16.1 12.9–20.0ROR 16.1 · calibrated p 0.006 ✓ | 15.4 EB05 12.8 · IC025 +3.5 3/3 methods agree vs other Prostaglandin Analogs: PRR 12.3 (9.1–16.7) | Labeled adverse reaction exact term | serious n=64 · ♀ 39% (drug 61%) | not reported in cached trials |
| Alcohol poisoning | 95 | 15.5 12.7–19.1ROR 15.6 · calibrated p 0.006 ✓ | 14.9 EB05 12.6 · IC025 +3.5 3/3 methods agree vs other Prostaglandin Analogs: only this drug | Not in label — unassessed | serious n=95 · ♀ 0% (drug 61%) · 100% clinician | not reported in cached trials |
| Punctate keratitis | 31 | 15.2 10.6–21.8ROR 15.2 · calibrated p 0.008 ✓ | 14.4 EB05 10.4 · IC025 +3.0 3/3 methods agree vs other Prostaglandin Analogs: PRR 12.6 (7.6–20.8) | Labeled adverse reaction exact term | serious n=31 · 100% clinician | not reported in cached trials |
| Eyelid disorder | 80 | 15.1 12.1–18.8ROR 15.1 · calibrated p 0.007 ✓ | 14.5 EB05 12.0 · IC025 +3.4 3/3 methods agree vs other Prostaglandin Analogs: PRR 11.3 (8.3–15.3) | Labeled (related wording) related wording | serious n=43 · 71% consumer | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Latanoprost as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00716742 — Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pr (N=1099, phase n/a; 1 AE terms posted; arms: Lumigan®; Travatan®; Xalatan®)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 | 5,926 | 32.6 31.8–33.4ROR 36.8 · calibrated p 8e-5 ✓ | 30.3 EB05 29.6 · IC025 +4.9 3/3 methods agree vs other Prostaglandin Analogs: PRR 12.2 (11.8–12.6) | Reporting / coding artifact | serious PRR 1.6 · 76% consumer | not reported in cached trials |
| Drug ineffective (drug did not work) | 3,234 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.327 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Prostaglandin Analogs: PRR 7.1 (6.8–7.4) | Reporting / coding artifact | serious PRR 1.4 | not reported in cached trials |
| Fatigue (tiredness) | 2,324 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.486 | 1.3 EB05 1.2 · IC025 +0.3 vs other Prostaglandin Analogs: PRR 28.7 (26.6–30.8) | Not in label — unassessed | serious PRR 1.5 | not reported in cached trials |
| Eye irritation | 2,250 | 17.6 16.9–18.3ROR 18.4 · calibrated p 0.003 ✓ | 16.9 EB05 16.3 · IC025 +4.0 3/3 methods agree vs other Prostaglandin Analogs: PRR 9.4 (8.9–9.9) | Not in label — unassessed | serious PRR 25.5 | not reported in cached trials |
| Headache | 1,805 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.452 | 1.2 EB05 1.2 · IC025 +0.2 vs other Prostaglandin Analogs: PRR 23.8 (22.0–25.7) | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Intraocular pressure increased (raised eye pressure) | 1,786 | 67.7 64.4–71.1ROR 70.2 · calibrated p 1e-6 ✓ | 58.3 EB05 56.0 · IC025 +5.8 3/3 methods agree vs other Prostaglandin Analogs: PRR 17.9 (16.7–19.3) | Likely indication confounding term in indications | serious PRR 65.8 | not reported in cached trials |
| Death | 1,657 | 0.8 0.8–0.8ROR 0.8 · calibrated p 0.184 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Prostaglandin Analogs: PRR 33.4 (30.5–36.6) | Outcome field, not a reaction | serious PRR 0.8 | NCT00716742: 5/364 (1.4%) on Latanoprost (serious AE) |
| Dyspnoea (shortness of breath) | 1,655 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.464 | 1.2 EB05 1.2 · IC025 +0.2 vs other Prostaglandin Analogs: PRR 26.5 (24.3–28.8) | Labeled adverse reaction exact term | serious PRR 1.4 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,638 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.353 | 1.1 EB05 1.0 · IC025 +0.0 vs other Prostaglandin Analogs: PRR 28.6 (26.2–31.2) | Not in label — unassessed | serious PRR 1.2 | not reported in cached trials |
| Eye pain | 1,638 | 12.8 12.2–13.4ROR 13.2 · calibrated p 0.012 ✓ | 12.4 EB05 11.9 · IC025 +3.5 3/3 methods agree vs other Prostaglandin Analogs: PRR 11.8 (11.1–12.7) | Labeled adverse reaction exact term | serious PRR 11.7 · 71% consumer | not reported in cached trials |
| Dizziness | 1,629 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.566 | 1.4 EB05 1.3 · IC025 +0.4 vs other Prostaglandin Analogs: PRR 25.8 (23.7–28.1) | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Off label use (used outside approved label) | 1,610 | 0.8 0.7–0.8ROR 0.8 · calibrated p 0.167 | 0.8 EB05 0.7 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Prostaglandin Analogs: PRR 21.4 (19.8–23.2) | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Nausea | 1,580 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.203 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Prostaglandin Analogs: PRR 27.3 (25.0–29.8) | Labeled adverse reaction exact term | serious PRR 1.1 | not reported in cached trials |
| Vision blurred (blurred vision) | 1,506 | 4.7 4.4–4.9ROR 4.8 · calibrated p 0.260 | 4.6 EB05 4.4 · IC025 +2.1 3/3 methods agree vs other Prostaglandin Analogs: PRR 13.9 (13.0–15.0) | Labeled (related wording) related wording | serious PRR 4.5 | not reported in cached trials |
| Fall | 1,439 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.855 | 1.8 EB05 1.7 · IC025 +0.8 vs other Prostaglandin Analogs: PRR 26.1 (23.9–28.6) | Not in label — unassessed | serious PRR 2.0 | not reported in cached trials |
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.
- Eyelash thickening — n=29, PRR 131.5
- Iris hyperpigmentation — n=36, PRR 87.9
- Steroid dependence — n=139, PRR 81.9
- Catarrh — n=138, PRR 77.0
- Reaction to preservatives — n=74, PRR 41.7
- Hypotony of eye — n=37, PRR 40.6
- Burns second degree — n=147, PRR 38.4
- Choroidal detachment — n=42, PRR 34.3
- Eye laser surgery — n=43, PRR 32.9
- Hyphaema — n=31, PRR 26.3
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 Latanoprost?
In FDA FAERS, the most frequently co-reported reaction terms for Latanoprost are fatigue, eye irritation, headache, intraocular pressure increased, dyspnoea, diarrhoea. 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 Latanoprost have an FDA boxed warning?
No. The FDA label retrieved for Latanoprost has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Latanoprost 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 1fba56a6-c8dc-4f34-b05d-efdea75d2fea, effective 20230131; matched on
openfda.generic_name.exact:"LATANOPROST") - 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, 1,196 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 - ClinicalTrials.gov API v2 (query
LATANOPROST, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.