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Uvadex Side Effects

Generic name: methoxsalen

Medically reviewed by Drugs.com. Last updated on Nov 16, 2023.

Note: This document contains side effect information about methoxsalen. Some dosage forms listed on this page may not apply to the brand name Uvadex.

For Healthcare Professionals

Applies to methoxsalen: compounding powder, injectable solution, oral capsule.

General

The most common adverse event was nausea, which may be minimized or avoided by taking the medication with milk or food, or dividing the dose into 2 portions taken approximately 30 minutes apart.[Ref]

Dermatologic

Very common (10% or more): Pruritus (10%)

Frequency not reported: Erythema, hypopigmentation, vesiculation and bullae formation, non-specific rash, herpes simplex, miliaria, urticaria, folliculitis, cutaneous tenderness, extension of psoriasis

Postmarketing reports: Rash[Ref]

-Pruritus can often be alleviated by 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 it resolves.

-Discontinue treatment until pruritus resolution for intractable generalized pruritus.

Erythema:

-Mild, transient erythema at 24 to 48 hours after PUVA therapy is expected and indicates a therapeutic reaction.

-Any area showing moderate (grade 2 or higher) erythema should be shielded during subsequent UVA exposure until the erythema has resolved.

-Grade 2 or higher erythema that appears within 24 hours after treatment may signal a potentially severe burn.

-Erythema may progressively worsen over the next 24 hours, since peak erythemal reaction characteristically occurs 48 hours or later after methoxsalen ingestion.

-Monitor the patient closely and protect from further UVA and sunlight exposures.

Differences between PUVA erythema and sunburn or UVB phototherapy:

-The percent transmission through skin of UVS varies from 0 to 34%, where UVA varies from 1 to 80% (UVA is transmitted through a larger percentage of the skin)

-PUVA induced DNA lesions may lead to a DNA crosslink, which is more lethal and psoralen-DNA photoproducts may be unfamiliar substrates for DNA repair enzymes.

-DNA synthesis is suppressed longer after PUVA.

-The time course of delayed erythema with PUVA is different and may not involve the usual mediators seen in sunburn; PUVA-induced redness may be just beginning at 24 hours (UVB erythema is past its peak by this time).

-Histological alterations from PUVA show more dermal vessel damage and longer duration of epidermal and dermal abnormalities.[Ref]

Cardiovascular

Common (1% to 10%): Hypotension

Frequency not reported: Arrhythmia[Ref]

Gastrointestinal

Very common (10% or more): Nausea (10%)

Common (1% to 10%): Vomiting

Frequency not reported: Gastrointestinal disturbances

Postmarketing reports: Dysgeusia[Ref]

Immunologic

Common (1% to 10%): Infection/catheter related infection/ sepsis

Frequency not reported: Folliculitis[Ref]

Psychiatric

Frequency not reported: Nervousness, insomnia, depression[Ref]

Hypersensitivity

Postmarketing reports: Allergic reaction[Ref]

Local

Common (1% to 10%): Vascular access complication[Ref]

Other

Common (1% to 10%): Transient fever

Frequency not reported: Edema, malaise

Postmarketing reports: Pyrexia[Ref]

Nervous system

Frequency not reported: Dizziness, headache[Ref]

Musculoskeletal

Frequency not reported: Leg cramps[Ref]

References

1. Product Information. Oxsoralen (methoxsalen). ICN Pharmaceuticals Inc. 2001;PROD.

2. Product Information. Uvadex (methoxsalen). Therakos Inc. 2006.

3. Product Information. Methoxsalen (methoxsalen). Strides Pharma Inc. 2017.

4. Cerner Multum, Inc. UK Summary of Product Characteristics.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.