Methoxsalen is a photoactivated radical generator indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. MedsAcross supplies Methoxsalen for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
III. INDICATIONS AND USAGE Photochemotherapy (Methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. Methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.
Source: US FDA prescribing information
of methoxsalen with the epidermal melanocytes and keratinocytes is not known. The best known biochemical reaction of methoxsalen is with DNA. Methoxsalen, upon photoactivation, conjugates and forms covalent bonds with DNA which leads to the formation of both monofunctional (addition to a single strand of DNA) and bifunctional (crosslinking of psoralen to both strands of DNA) adducts (Dall' Acqua et al., 1971 5, Cole, 1970 6, Musajo et al., 1974 7, Dall' Acqua et al., 1979 8 ). Reactions with proteins have also been described (Yoshikawa, et al., 1979 9 ). Methoxsalen acts as a photosensitizer. Administration of the drug and subsequent exposure to UVA can lead to cell injury. Orally administered methoxsalen reaches the skin via the blood and UVA penetrates well into the skin. If sufficient cell injury occurs in the skin, an inflammatory reaction occurs.
Source: US FDA prescribing information
IX. DRUG DOSAGE & ADMINISTRATION CAUTION: Methoxsalen Capsules, USP represents a new dose form of methoxsalen. This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Each patient should be evaluated by determining the minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photochemotherapy with this dosage form. Human bioavailability studies have indicated the following drug dosage and administration directions are to be used as a guideline only. PSORIASIS THERAPY 1.
Source: US FDA prescribing information
IV. CONTRAINDICATIONS A. Patients exhibiting idiosyncratic reactions to psoralen compounds. B. Patients possessing a specific history of light sensitive disease states should not initiate methoxsalen therapy except under special circumstances. Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism. C. Patients with melanoma or with a history of melanoma. D. Patients with invasive squamous cell carcinomas. E. Patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses.
Source: US FDA prescribing information
Methoxsalen with ultraviolet (UV) radiation should be used only by physicians who have special competence in the diagnosis and treatment of psoriasis and who have special training and experience in photochemotherapy. The use of Psoralen and ultraviolet radiation therapy should be under constant supervision of such a physician. V. WARNINGS - GENERAL A. SKIN BURNING: Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of the drug and/or exposure schedules are exceeded. B. CARCINOGENICITY: ANIMAL STUDIES: Topical or intraperitoneal methoxsalen has been reported to be a potent photocarcinogen in albino mice and hairless mice (Hakim et al., 1960 10 ).
Source: US FDA prescribing information
VII. 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.
Source: US FDA prescribing information
D. DRUG INTERACTIONS: See WARNINGS – GENERAL.
Source: US FDA prescribing information
Store at 20° to 25 °C (68° to 77 °F), excursions permitted between 15 °C - 30 °C (59 °F - 86 °F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Methoxsalen, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Methoxsalen 10 mg capsuleOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 3 December 1954 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Methoxsalen in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Methoxsalen and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Methoxsalen on 3 December 1954, according to Drugs@FDA.
No listed presentation of Methoxsalen is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Methoxsalen is classified under ATC code D05AD02 (Methoxsalen).
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