What the label lists and what reports show
Methoxsalen side effects
Methoxsalen's FDA label: “The most commonly reported side effect of methoxsalen alone is nausea, which occurs with approximately 10% of all patients.” FAERS holds 123 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 vomiting (13 reports).
- Generic listed
- Boxed warning
Check it at the source: the methoxsalen FDA label on DailyMed (effective June 24, 2026, Strides Pharma Science Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most commonly reported side effect of methoxsalen alone is nausea, which occurs with approximately 10% of all patients.
From the label: adverse reactions, continuedVII. ADVERSE REACTIONS: A. METHOXSALEN: The most commonly reported side effect of methoxsalen alone is nausea, which occurs with approximately 10% of all patients. This effect may be minimized or avoided by instructing the patient to take methoxsalen in milk or food, or to divide the dose into two portions, taken approximately one-half hour apart. Other effects include nervousness, insomnia, and depression. B. COMBINED METHOXSALEN/UVA THERAPY: PRURITUS: This adverse reaction occurs with approximately 10% of all patients. In most cases, pruritus can be alleviated with frequent application of bland emollients or other topical agents; severe pruritus may require systemic treatment. If pruritus is unresponsive to these measures, shield pruritic areas from further UVA exposure until the condition resolves. If intractable pruritus is generalized, UVA treatment should be discontinued until the pruritus disappears. ERYTHEMA: Mild, transient erythema at 24-48 hours after PUVA therapy is an expected reaction and indicates that a therapeutic interaction between methoxsalen and UVA occurred. Any area showing moderate erythema (greater than Grade 2 - See Table 1 for grades of erythema) should be shielded during subsequent UVA exposures until the erythema has resolved. Erythema greater than Grade 2 which appears within 24 hours after UVA treatment may signal a potentially severe burn. …
Source: FDA drug label, ANDA202687 (Onesource), as published by Strides Pharma Science Limited, effective June 24, 2026 (SPL set a6ec8292-9189-4ebd-862a-e1725eb29eef), via openFDA; the full label on DailyMed
What do FAERS reports show?
123 reports list methoxsalen among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 30 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 21 reactions below, 3 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.
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?
- Methoxsalen: 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