Drug · FAERS side-effect profile with label screen

Verteporfin For side effects: what 1,480 FDA adverse event reports show

Verteporfin For Injection · 19 reaction terms · 917 drug–reaction co-reports · data 2026-09-14

Drug class

Photoenhancer

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Verteporfin For Injection (Visudyne)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,480 reports · 89% serious · 59 with death outcome · 42% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VISUDYNE ® (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), pathologic myopia or presumed ocular histoplasmosis. There is insufficient evidence to indicate VISUDYNE for the treatment of predominantly occult subfoveal CNV.

FDA label, Indications and Usage

What it is

VISUDYNE ® (verteporfin for injection) is a sterile, photoenhancer which is light activated drug when used in photodynamic therapy for intravenous administration. The finished drug product is a lyophilized dark green cake.

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 17 strongest signals

Labeled adverse reaction 2Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 1Not in label — unassessed 5

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. 2 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
Visual acuity reduced	400	171.3 157.4–186.4ROR 234.3 · χ² 66,830 / p <1e-300	167.9 EB05 154.5 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 146.1 · 94% clinician	no trial data cached
Retinal detachment	66	102.4 80.8–129.8ROR 107.1 · χ² 6,482 / p <1e-300	98.8 EB05 80.4 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 66.8 · 98% clinician	no trial data cached
Macular degeneration	59	70.5 54.9–90.6ROR 73.4 · χ² 3,955 / p <1e-300	68.6 EB05 55.2 · IC025 +5.0 3/3 methods agree	Likely indication confounding term in indications	serious PRR 48.2 · 95% clinician	no trial data cached
Eye haemorrhage	25	26.5 18.0–39.2ROR 27.0 · χ² 588 / p 3e-130	26.0 EB05 18.5 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.7	no trial data cached
Disease progression	173	20.8 18.1–23.9ROR 23.4 · χ² 3,257 / p <1e-300	20.7 EB05 18.3 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 15.5 · 98% clinician	no trial data cached
Intraocular pressure increased (raised eye pressure)	16	17.7 10.9–28.8ROR 17.9 · χ² 235 / p 2e-53	17.0 EB05 10.7 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 16.9	no trial data cached
Injection site extravasation	13	14.8 8.6–25.4ROR 14.9 · χ² 153 / p 2e-35	13.6 EB05 7.6 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious n=14	no trial data cached
Blindness unilateral	13	13.1 7.6–22.5ROR 13.2 · χ² 133 / p 4e-31	11.7 EB05 6.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Cerebral infarction	20	11.6 7.5–17.9ROR 11.7 · χ² 183 / p 5e-42	10.7 EB05 6.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.5 · ♀ 15% (drug 42%)	no trial data cached
Blindness	32	11.1 7.9–15.7ROR 11.4 · χ² 286 / p 2e-64	10.6 EB05 7.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Eye inflammation	5	7.5 3.1–18.0ROR 7.5 · χ² 22 / p 1e-6	4.9 EB05 2.2 · IC025 +0.7 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Scar	9	7.4 3.9–14.3ROR 7.5 · χ² 44 / p 2e-11	5.7 EB05 3.1 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Cataract	27	6.5 4.4–9.4ROR 6.6 · χ² 119 / p 5e-28	5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.7	no trial data cached
Disease recurrence	20	5.9 3.8–9.2ROR 6.0 · χ² 77 / p 7e-19	5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6	no trial data cached
Drug resistance	8	4.4 2.2–8.8ROR 4.4 · χ² 18 / p 1e-5	3.6 EB05 2.0 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2	no trial data cached
Drug effect incomplete	10	3.8 2.1–7.1ROR 3.9 · χ² 18 / p 9e-6	3.4 EB05 2.0 · IC025 +0.7	Reporting / coding artifact	serious PRR 8.8	no trial data cached
Inappropriate schedule of drug administration	14	2.7 1.6–4.6ROR 2.8 · χ² 14 / p 1e-4	2.6 EB05 1.7 · IC025 +0.5	Reporting / coding artifact	serious PRR 6.2	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
Visual acuity reduced	400	171.3 157.4–186.4ROR 234.3 · χ² 66,830 / p <1e-300	167.9 EB05 154.5 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 146.1 · 94% clinician	no trial data cached
Disease progression	173	20.8 18.1–23.9ROR 23.4 · χ² 3,257 / p <1e-300	20.7 EB05 18.3 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 15.5 · 98% clinician	no trial data cached
Retinal detachment	66	102.4 80.8–129.8ROR 107.1 · χ² 6,482 / p <1e-300	98.8 EB05 80.4 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 66.8 · 98% clinician	no trial data cached
Macular degeneration	59	70.5 54.9–90.6ROR 73.4 · χ² 3,955 / p <1e-300	68.6 EB05 55.2 · IC025 +5.0 3/3 methods agree	Likely indication confounding term in indications	serious PRR 48.2 · 95% clinician	no trial data cached
Blindness	32	11.1 7.9–15.7ROR 11.4 · χ² 286 / p 2e-64	10.6 EB05 7.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	no trial data cached
Cataract	27	6.5 4.4–9.4ROR 6.6 · χ² 119 / p 5e-28	5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.7	no trial data cached
Eye haemorrhage	25	26.5 18.0–39.2ROR 27.0 · χ² 588 / p 3e-130	26.0 EB05 18.5 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.7	no trial data cached
Disease recurrence	20	5.9 3.8–9.2ROR 6.0 · χ² 77 / p 7e-19	5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6	no trial data cached
Cerebral infarction	20	11.6 7.5–17.9ROR 11.7 · χ² 183 / p 5e-42	10.7 EB05 6.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.5 · ♀ 15% (drug 42%)	no trial data cached
Intraocular pressure increased (raised eye pressure)	16	17.7 10.9–28.8ROR 17.9 · χ² 235 / p 2e-53	17.0 EB05 10.7 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 16.9	no trial data cached
Inappropriate schedule of drug administration	14	2.7 1.6–4.6ROR 2.8 · χ² 14 / p 1e-4	2.6 EB05 1.7 · IC025 +0.5	Reporting / coding artifact	serious PRR 6.2	no trial data cached
Blindness unilateral	13	13.1 7.6–22.5ROR 13.2 · χ² 133 / p 4e-31	11.7 EB05 6.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Injection site extravasation	13	14.8 8.6–25.4ROR 14.9 · χ² 153 / p 2e-35	13.6 EB05 7.6 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious n=14	no trial data cached
Drug effect incomplete	10	3.8 2.1–7.1ROR 3.9 · χ² 18 / p 9e-6	3.4 EB05 2.0 · IC025 +0.7	Reporting / coding artifact	serious PRR 8.8	no trial data cached
Scar	9	7.4 3.9–14.3ROR 7.5 · χ² 44 / p 2e-11	5.7 EB05 3.1 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.4	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.

Visual acuity reduced — n=400, PRR 171.3
Cerebral infarction — n=20, PRR 11.6
Blindness — n=32, PRR 11.1

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 Verteporfin For?

In FDA FAERS, the most frequently co-reported reaction terms for Verteporfin For are visual acuity reduced, retinal detachment, macular degeneration, blindness, cataract, eye haemorrhage. 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 Verteporfin For have an FDA boxed warning?

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

Do FAERS signals prove that Verteporfin For 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 2f0a34ce-3c57-4ac8-b28e-512be807272f, effective 20230224; matched on openfda.generic_name.exact:"VERTEPORFIN FOR INJECTION")
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, 19 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.