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Methoxsalen Side Effects

The most commonly reported side effects of methoxsalen include product use in unapproved indication, off label use, and condition aggravated, based on 788 FDA adverse event reports from 2004 to 2025.

Methoxsalen side effects

Percentages show how often each reaction appears relative to total reports for methoxsalen.

1
Product Use In Unapproved Indication43.1%340
2
Off Label Use6.9%54
3
Condition Aggravated5.5%43
4
Pulmonary Embolism4.7%37
5
Disease Progression4.6%36
6
Death4.3%34
7
Infection4.2%33
8
Hypotension3.6%28
9
Pyrexia3.4%27
10
Vomiting3.2%25
11
Nausea3.2%25
12
Chronic Graft Versus Host Disease2.9%23
13
Dyspnoea2.8%22
14
Graft Versus Host Disease2.5%20
15
Fatigue2.4%19

These are voluntary reports and do not establish that methoxsalen caused these reactions.

Report severity

91.6%Serious722 reports
21.8%Hospitalizations172 reports
22.5%Fatal177 reports

Seriousness is determined by the reporter, not by OpenClaim.

Methoxsalen drug interactions

Other drugs that appear in adverse event reports alongside methoxsalen. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Methotrexate3.9%31
2
Ruxolitinib3.3%26
3
Cyclosporine3.0%24
4
Tacrolimus2.2%17
5
Bexarotene1.9%15
6
Rituximab1.6%13
7
Etanercept1.5%12
8
Mycophenolate1.5%12
9
Adalimumab1.4%11
10
Mechlorethamine-hydrochloride1.4%11
11
Methylprednisolone1.1%9
12
Prednisolone1.1%9
13
Gemcitabine1.0%8
14
Heparin1.0%8
15
Hydromorphone-hydrochloride1.0%8

Taken alongside

1
Heparin16.0%126
2
Tacrolimus8.9%70
3
Prednisone8.2%65
4
Mycophenolate6.3%50
5
Dextrose6.3%50
6
Prednisolone6.0%47
7
Cyclosporine5.8%46
8
Acyclovir4.9%39
9
Albuterol4.4%35
10
Acetaminophen3.9%31
11
Diphenhydramine3.7%29
12
Ergocalciferol3.4%27
13
Ruxolitinib3.4%27
14
Ondansetron3.2%25
15
Aspirin3.0%24

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports methoxsalen side effects

36.9% of methoxsalen adverse event reports involve female patients and 39.7% involve male patients. The largest age group is adult at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female36.9%
Male39.7%
Unknown23.4%

Age group

< 22.5%
2–1111.1%
12–176.8%
18–6460.4%
65+19.2%

What is methoxsalen used for

Conditions and purposes for which patients were taking methoxsalen when the adverse event was reported.

Acute Graft Versus Host DiseaseAcute Graft Versus Host Disease In LiverAcute Graft Versus Host Disease In SkinAcute Myeloid LeukaemiaAnticoagulant TherapyAsthmaAcute Graft Versus Host DiseaseAcute Graft Versus Host Disease In IntestineAcute Graft Versus Host Disease In LiverAcute Graft Versus Host Disease In SkinAcute Lymphocytic LeukaemiaAdverse EventAmyotrophic Lateral SclerosisBronchiolitis Obliterans SyndromeBronchiolitis Obliterans Syndrome

Showing 15 of 119 indications

Methoxsalen brand names and reporting trend

Methoxsalen is sold under the brand name Oxsoralen.

Brand names

Oxsoralen135

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking methoxsalen with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.