OpenClaim

Tretinoin Side Effects

The most commonly reported side effects of tretinoin include off label use, pain, and product use in unapproved indication, based on 10,150 FDA adverse event reports from 2004 to 2025. 9.5% of reports found the drug to be ineffective.

Tretinoin side effects

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

1
Off Label Use9.6%979
2
Drug Ineffective9.5%966
3
Pain5.1%519
4
Product Use In Unapproved Indication5.1%515
5
Vomiting4.6%469
6
Rash4.4%444
7
Nausea4.3%441
8
Erythema4.1%421
9
Headache4.1%420
10
Diarrhoea3.8%385
11
Condition Aggravated3.7%378
12
Paraesthesia3.7%374
13
Fatigue3.4%349
14
Pruritus3.3%340
15
Hypoaesthesia3.3%334

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

Report severity

59.4%Serious6,034 reports
22.2%Hospitalizations2,253 reports
9.4%Fatal959 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tretinoin drug interactions

Other drugs that appear in adverse event reports alongside tretinoin. 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
Arsenic-trioxide7.9%802
2
Sodium-oxybate6.7%678
3
Idarubicin-hydrochloride6.0%611
4
Methotrexate5.8%590
5
Hydroquinone5.0%506
6
Fluocinolone-acetonide4.9%499
7
Cytarabine4.5%452
8
Pantoprazole-sodium4.2%427
9
Cetirizine-hydrochloride4.0%401
10
Topiramate3.9%394
11
Lamotrigine3.8%390
12
Trazodone-hydrochloride3.7%378
13
Adalimumab3.7%375
14
Ergocalciferol3.7%372
15
Candesartan-cilexetil3.6%366

Taken alongside

1
Ergocalciferol10.8%1,101
2
Acetaminophen10.3%1,043
3
Clindamycin7.9%801
4
Fluticasone7.3%738
5
Albuterol7.3%738
6
Levothyroxine-sodium6.8%691
7
Omeprazole5.9%597
8
Prednisone5.7%582
9
Aspirin5.5%562
10
Ibuprofen5.5%555
11
Gabapentin4.8%488
12
Ondansetron4.7%482
13
Triamcinolone4.7%479
14
Cetirizine-hydrochloride4.6%468
15
Doxycycline4.2%431

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 tretinoin side effects

65.1% of tretinoin adverse event reports involve female patients and 22.3% involve male patients. The largest age group is adult at 70%. These figures reflect who reports side effects, not underlying risk.

Sex

Female65.1%
Male22.3%
Unknown12.7%

Age group

< 20.9%
2–112.7%
12–176.6%
18–6469.6%
65+20.2%

What is tretinoin used for

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

Abnormal Palmar/plantar CreasesAbnormal Sensation In EyeAcanthosis NigricansAccidental Exposure To ProductAcneAcne ConglobataAcne CysticActinic KeratosisAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RecurrentAcute Promyelocytic LeukaemiaAcute Promyelocytic Leukemia

Showing 15 of 384 indications

Tretinoin brand names and reporting trend

Tretinoin is sold under the brand name Atralin.

Brand names

Atralin7,543

Quarterly reports (20042025)

20052010201520202025

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

Taking tretinoin with another medication?

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