Drug · FAERS side-effect profile with label screen
Tropicamide side effects: what 1,619 FDA adverse event reports show
Who reports
1,619 reports · 85% serious · 71 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For mydriasis and cycloplegia for diagnostic procedures.
FDA label, Indications and Usage
What it is
Rx Only DESCRIPTION Tropicamide Ophthalmic Solution, USP, 0.5% is an anticholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure: Established name: Tropicamide ophthalmic solution
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
Reporting / coding artifact 2Lab value / disease marker 3No label text to screen 35
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 28 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 |
|---|---|---|---|---|---|---|
| Vitreous floaters | 67 | 89.7 70.9–113.5ROR 93.5 · χ² 5,752 / p <1e-300 | 87.0 EB05 70.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=60 | no trial data cached |
| Eye inflammation | 60 | 82.9 64.6–106.4ROR 86.1 · χ² 4,744 / p <1e-300 | 80.3 EB05 64.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=59 · ♀ 78% (drug 58%) | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 42 | 42.5 31.5–57.3ROR 43.6 · χ² 1,656 / p <1e-300 | 41.6 EB05 32.1 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 40.4 | no trial data cached |
| Uveitis | 42 | 40.4 30.0–54.5ROR 41.4 · χ² 1,570 / p <1e-300 | 39.6 EB05 30.5 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.3 | no trial data cached |
| Visual acuity reduced | 98 | 38.0 31.4–46.1ROR 40.4 · χ² 3,490 / p <1e-300 | 37.6 EB05 31.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.9 | no trial data cached |
| Mydriasis | 30 | 30.4 21.3–43.3ROR 30.9 · χ² 822 / p 5e-181 | 29.8 EB05 21.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.8 | no trial data cached |
| Photophobia (light sensitivity) | 43 | 29.9 22.3–40.2ROR 30.7 · χ² 1,170 / p 8e-257 | 29.5 EB05 22.8 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.8 | no trial data cached |
| Sars-cov-2 test positive | 28 | 27.2 18.8–39.3ROR 27.7 · χ² 680 / p 4e-150 | 26.7 EB05 19.4 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=28 · ♀ 100% (drug 58%) · 96% clinician | no trial data cached |
| Eye pain | 115 | 27.0 22.7–32.2ROR 29.0 · χ² 2,858 / p <1e-300 | 26.9 EB05 23.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.9 | no trial data cached |
| Retinal detachment | 17 | 24.0 14.9–38.5ROR 24.2 · χ² 351 / p 1e-78 | 23.4 EB05 15.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.4 | no trial data cached |
| Ocular discomfort | 20 | 23.9 15.4–36.9ROR 24.2 · χ² 416 / p 1e-92 | 23.4 EB05 15.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Blindness unilateral | 24 | 22.1 14.9–32.9ROR 22.4 · χ² 462 / p 8e-103 | 21.7 EB05 15.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 | no trial data cached |
| Eye disorder | 50 | 19.8 15.1–26.0ROR 20.4 · χ² 873 / p 3e-192 | 19.6 EB05 15.4 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.5 | no trial data cached |
| Blindness | 60 | 19.1 14.9–24.5ROR 19.8 · χ² 1,012 / p 2e-222 | 19.0 EB05 15.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 | no trial data cached |
| Nerve injury | 15 | 17.4 10.5–28.9ROR 17.6 · χ² 216 / p 3e-49 | 16.7 EB05 10.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.3 | no trial data cached |
| Macular degeneration | 16 | 17.4 10.7–28.4ROR 17.6 · χ² 231 / p 2e-52 | 16.8 EB05 10.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 | no trial data cached |
| Body temperature decreased | 13 | 17.0 9.9–29.2ROR 17.1 · χ² 180 / p 3e-41 | 16.0 EB05 9.2 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 12.7 | no trial data cached |
| Eye haemorrhage | 16 | 15.5 9.5–25.3ROR 15.7 · χ² 203 / p 2e-46 | 14.7 EB05 9.0 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 | no trial data cached |
| Vision blurred (blurred vision) | 159 | 15.1 13.0–17.5ROR 16.6 · χ² 2,089 / p <1e-300 | 15.0 EB05 13.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.8 | no trial data cached |
| Ocular hyperaemia | 54 | 15.0 11.5–19.5ROR 15.5 · χ² 692 / p 1e-152 | 14.8 EB05 11.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.1 | no trial data cached |
| Eye irritation | 64 | 14.9 11.7–18.9ROR 15.5 · χ² 816 / p 8e-180 | 14.8 EB05 11.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.8 | no trial data cached |
| Cataract | 68 | 14.9 11.8–18.8ROR 15.5 · χ² 867 / p 7e-191 | 14.7 EB05 12.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial data cached |
| Eye discharge | 11 | 14.0 7.7–25.2ROR 14.0 · χ² 120 / p 4e-28 | 12.3 EB05 6.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Ischaemic stroke | 15 | 10.9 6.6–18.0ROR 11.0 · χ² 125 / p 3e-29 | 9.5 EB05 5.7 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Candida infection (yeast infection) | 14 | 10.9 6.5–18.3ROR 11.0 · χ² 116 / p 3e-27 | 9.4 EB05 5.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.5 | no trial data cached |
| Hemiparesis | 14 | 10.6 6.3–17.9ROR 10.7 · χ² 113 / p 1e-26 | 9.2 EB05 5.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Eye pruritus | 27 | 10.6 7.3–15.4ROR 10.8 · χ² 226 / p 2e-51 | 9.9 EB05 6.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.7 | no trial data cached |
| Lacrimation increased | 21 | 9.1 6.0–13.9ROR 9.2 · χ² 144 / p 2e-33 | 8.1 EB05 5.4 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 | no trial data cached |
| Visual impairment | 85 | 9.0 7.3–11.0ROR 9.4 · χ² 596 / p 7e-132 | 8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 | no trial data cached |
| Product use complaint | 10 | 8.4 4.5–15.5ROR 8.4 · χ² 58 / p 2e-14 | 6.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Cold sweat | 11 | 8.1 4.5–14.6ROR 8.1 · χ² 61 / p 2e-15 | 6.4 EB05 3.7 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 | no trial data cached |
| Pallor | 17 | 8.1 5.0–13.0ROR 8.2 · χ² 98 / p 2e-23 | 6.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Dry eye | 30 | 8.0 5.6–11.4ROR 8.2 · χ² 178 / p 7e-41 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 | no trial data cached |
| Thirst | 11 | 8.0 4.4–14.4ROR 8.0 · χ² 61 / p 4e-15 | 6.4 EB05 3.7 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 | no trial data cached |
| Anaphylactic shock | 14 | 7.1 4.2–11.9ROR 7.1 · χ² 67 / p 1e-16 | 5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Bradycardia (slow heart rate) | 29 | 7.1 4.9–10.1ROR 7.2 · χ² 145 / p 8e-34 | 6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 · 93% clinician | no trial data cached |
| Eye swelling | 20 | 7.0 4.5–10.8ROR 7.1 · χ² 97 / p 3e-23 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial data cached |
| Post procedural complication | 10 | 6.7 3.6–12.5ROR 6.8 · χ² 43 / p 2e-11 | 5.3 EB05 3.1 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Glaucoma | 10 | 6.7 3.6–12.5ROR 6.8 · χ² 43 / p 2e-11 | 5.3 EB05 3.1 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 | no trial data cached |
| Inflammation | 26 | 6.6 4.5–9.6ROR 6.7 · χ² 117 / p 1e-27 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | 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 |
|---|---|---|---|---|---|---|
| Vision blurred (blurred vision) | 159 | 15.1 13.0–17.5ROR 16.6 · χ² 2,089 / p <1e-300 | 15.0 EB05 13.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.8 | no trial data cached |
| Eye pain | 115 | 27.0 22.7–32.2ROR 29.0 · χ² 2,858 / p <1e-300 | 26.9 EB05 23.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.9 | no trial data cached |
| Visual acuity reduced | 98 | 38.0 31.4–46.1ROR 40.4 · χ² 3,490 / p <1e-300 | 37.6 EB05 31.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.9 | no trial data cached |
| Visual impairment | 85 | 9.0 7.3–11.0ROR 9.4 · χ² 596 / p 7e-132 | 8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 | no trial data cached |
| Cataract | 68 | 14.9 11.8–18.8ROR 15.5 · χ² 867 / p 7e-191 | 14.7 EB05 12.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial data cached |
| Vitreous floaters | 67 | 89.7 70.9–113.5ROR 93.5 · χ² 5,752 / p <1e-300 | 87.0 EB05 70.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=60 | no trial data cached |
| Eye irritation | 64 | 14.9 11.7–18.9ROR 15.5 · χ² 816 / p 8e-180 | 14.8 EB05 11.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.8 | no trial data cached |
| Blindness | 60 | 19.1 14.9–24.5ROR 19.8 · χ² 1,012 / p 2e-222 | 19.0 EB05 15.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 | no trial data cached |
| Eye inflammation | 60 | 82.9 64.6–106.4ROR 86.1 · χ² 4,744 / p <1e-300 | 80.3 EB05 64.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=59 · ♀ 78% (drug 58%) | no trial data cached |
| Ocular hyperaemia | 54 | 15.0 11.5–19.5ROR 15.5 · χ² 692 / p 1e-152 | 14.8 EB05 11.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.1 | no trial data cached |
| Eye disorder | 50 | 19.8 15.1–26.0ROR 20.4 · χ² 873 / p 3e-192 | 19.6 EB05 15.4 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.5 | no trial data cached |
| Photophobia (light sensitivity) | 43 | 29.9 22.3–40.2ROR 30.7 · χ² 1,170 / p 8e-257 | 29.5 EB05 22.8 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.8 | no trial data cached |
| Uveitis | 42 | 40.4 30.0–54.5ROR 41.4 · χ² 1,570 / p <1e-300 | 39.6 EB05 30.5 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.3 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 42 | 42.5 31.5–57.3ROR 43.6 · χ² 1,656 / p <1e-300 | 41.6 EB05 32.1 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 40.4 | no trial data cached |
| Dry eye | 30 | 8.0 5.6–11.4ROR 8.2 · χ² 178 / p 7e-41 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Tropicamide?
In FDA FAERS, the most frequently co-reported reaction terms for Tropicamide are vision blurred, eye pain, visual acuity reduced, visual impairment, cataract, vitreous floaters. 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 Tropicamide have an FDA boxed warning?
No. The FDA label retrieved for Tropicamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tropicamide 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 521592d1-53a1-4314-8b3f-d808f3bccfcd, effective 20220126; matched on
openfda.generic_name.exact:"TROPICAMIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 68 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.