What the label lists and what reports show
Verteporfin side effects
Verteporfin's FDA label: “Most common adverse reactions (incidence ˃10%) are injection site reactions and visual disturbances.” FAERS holds 1,480 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is visual acuity reduced (400 reports).
- No generic listed
Check it at the source: the verteporfin FDA label on DailyMed (effective August 27, 2025, Bausch Health US LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ˃10%) are injection site reactions and visual disturbances.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Local Adverse Reactions – Extravasation [see Warnings and Precautions ( 5.1 )] Exposure to Sun or Direct Light [see Warnings and Precautions ( 5.2 )] Decreased Vision after Treatment [see Warnings and Precautions ( 5.3 )] Porphyria and Hypersensitivity [see Contraindications ( 4 )] Most common adverse reactions (incidence ˃10%) are injection site reactions and visual disturbances. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Severe chest pain, vasovagal and hypersensitivity reactions have been reported. Vasovagal and hypersensitivity reactions on rare occasions can be severe. These reactions may include syncope, sweating, dizziness, rash, dyspnea, flushing and changes in blood pressure and heart rate. General symptoms can include headache, malaise, urticaria, and pruritus.
Source: FDA drug label, Bausch Health US LLC, effective August 27, 2025 (SPL set 952f4c80-50b1-4308-9ee6-311ffefb13df), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,480 reports list verteporfin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 59 are coded as a death and 192 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Verteporfin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions