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Alitretinoin Side Effects

The most commonly reported side effects of alitretinoin include off label use, drug intolerance, and headache, based on 118 FDA adverse event reports from 2009 to 2025. 17.8% of reports found the drug to be ineffective.

#1 Reported: Off Label UseAll side effects ↓Top Co-Medication: MethotrexateDrug interactions ↓69% of Reports Are AdultDemographics ↓

Alitretinoin side effects

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

1
Off Label Use19.5%23
2
Drug Ineffective17.8%21
3
Drug Intolerance7.6%9
4
Headache6.8%8
5
Treatment Failure6.8%8
6
Vomiting6.8%8
7
Hypercholesterolaemia6.8%8
8
Product Use In Unapproved Indication5.9%7
9
Nausea5.1%6
10
Fatigue5.1%6
11
Diarrhoea5.1%6
12
Localised Infection5.1%6
13
Drug Eruption5.1%6
14
Pruritus4.2%5
15
Cough4.2%5

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

Report severity

87.3%Serious103 reports
22.9%Hospitalizations27 reports
4.2%Fatal5 reports

Seriousness is determined by the reporter, not by OpenClaim.

Alitretinoin drug interactions

Other drugs that appear in adverse event reports alongside alitretinoin. 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
Methotrexate17.8%21
2
Acitretin16.9%20
3
Adalimumab12.7%15
4
Tacrolimus11.9%14
5
Prednisone10.2%12
6
Cyclosporine8.5%10
7
Ustekinumab7.6%9
8
Clobetasol-propionate5.9%7
9
Etanercept5.9%7
10
Risankizumab-rzaa5.9%7
11
Apremilast5.9%7
12
Dupilumab5.9%7
13
Betamethasone5.1%6
14
Cyclophosphamide4.2%5
15
Prednisolone4.2%5

Taken alongside

1
Methotrexate11.9%14
2
Acitretin8.5%10
3
Clobetasol-propionate6.8%8
4
Celecoxib6.8%8
5
Cetirizine-hydrochloride5.9%7
6
Atorvastatin-calcium5.9%7
7
Acetaminophen5.9%7
8
Pantoprazole-sodium5.1%6
9
Pregabalin5.1%6
10
Naproxen5.1%6
11
Folic-acid4.2%5
12
Hydroxychloroquine-sulfate4.2%5
13
Levothyroxine-sodium4.2%5
14
Sulfasalazine4.2%5
15
Albuterol4.2%5

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 alitretinoin side effects

50.8% of alitretinoin adverse event reports involve female patients and 34.7% involve male patients. The largest age group is adult at 69%. These figures reflect who reports side effects, not underlying risk.

Sex

Female50.8%
Male34.7%
Unknown14.4%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6469.5%
65+30.5%

What is alitretinoin used for

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

Acute Myeloid LeukaemiaBenign Familial PemphigusChronic Cutaneous Lupus ErythematosusCutaneous AmyloidosisCutaneous T-cell LymphomaCutaneous T-cell LymphomaDermatitisDermatitis AtopicDrug Use For Unknown IndicationDrug EruptionEczemaHand DermatitisKaposi^s SarcomaKeratosis FollicularKaposi^s Sarcoma

Showing 15 of 33 indications

Alitretinoin brand names and reporting trend

Alitretinoin is sold under the brand name Panretin.

Brand names

Panretin131

Quarterly reports (2009–2025)

200920122016202020242025

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

Taking alitretinoin with another medication?

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