PSORALEN: 52 Adverse Event Reports & Safety Profile
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52
Total FAERS Reports
3 (5.8%)
Deaths Reported
3
Hospitalizations
52
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities
First Report: 20100101 · Latest Report: 20211108
What Are the Most Common PSORALEN Side Effects?
#1 Most Reported
Drug ineffective
13 reports (25.0%)
#2 Most Reported
Off label use
12 reports (23.1%)
#3 Most Reported
Psoriasis
11 reports (21.2%)
All PSORALEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 13 | 25.0% | 3 | 0 |
| Off label use | 12 | 23.1% | 1 | 1 |
| Hypertension | 11 | 21.2% | 0 | 0 |
| Psoriasis | 11 | 21.2% | 0 | 0 |
| Loss of personal independence in daily activities | 10 | 19.2% | 0 | 0 |
| Pruritus | 10 | 19.2% | 0 | 1 |
| Psoriatic arthropathy | 10 | 19.2% | 0 | 0 |
| Skin exfoliation | 10 | 19.2% | 0 | 0 |
| Agoraphobia | 9 | 17.3% | 0 | 0 |
| Anxiety | 9 | 17.3% | 0 | 0 |
| Arthropathy | 9 | 17.3% | 0 | 0 |
| Clumsiness | 9 | 17.3% | 0 | 0 |
| Cognitive disorder | 9 | 17.3% | 0 | 0 |
| Depression | 9 | 17.3% | 0 | 0 |
| Dermatitis | 9 | 17.3% | 0 | 0 |
| Disturbance in social behaviour | 9 | 17.3% | 0 | 0 |
| Eye irritation | 9 | 17.3% | 0 | 0 |
| Fatigue | 9 | 17.3% | 0 | 0 |
| Feeling abnormal | 9 | 17.3% | 0 | 0 |
| Formication | 9 | 17.3% | 0 | 0 |
Who Reports PSORALEN Side Effects? Age & Gender Data
Gender: 48.1% female, 51.9% male. Average age: 53.2 years. Most reports from: GB. View detailed demographics →
Is PSORALEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 2 | 0 | 2 |
| 2013 | 7 | 0 | 0 |
| 2015 | 1 | 0 | 1 |
| 2019 | 3 | 3 | 0 |
| 2021 | 2 | 0 | 0 |
What Is PSORALEN Used For?
| Indication | Reports |
|---|---|
| Cutaneous t-cell lymphoma | 14 |
| Product used for unknown indication | 13 |
Official FDA Label for PSORALEN
Official prescribing information from the FDA-approved drug label.