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Palovarotene Side Effects

The most commonly reported side effects of palovarotene include condition aggravated, pruritus, and skin exfoliation, based on 79 FDA adverse event reports from 2004 to 2025. 3.8% of reports found the drug to be ineffective.

Palovarotene side effects

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

1
Condition Aggravated32.9%26
2
Pruritus11.4%9
3
Skin Exfoliation8.9%7
4
Dry Skin8.9%7
5
Product Dose Omission Issue8.9%7
6
Off Label Use7.6%6
7
Rash6.3%5
8
Pain In Extremity5.1%4
9
Nausea5.1%4
10
Pain3.8%3
11
Dyspnoea3.8%3
12
Drug Ineffective3.8%3
13
Pneumonia3.8%3
14
Dyspnoea3.8%3
15
Headache3.8%3

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

Report severity

46.8%Serious37 reports
15.2%Hospitalizations12 reports
2.5%Fatal2 reports

Seriousness is determined by the reporter, not by OpenClaim.

Palovarotene drug interactions

Other drugs that appear in adverse event reports alongside palovarotene. 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
Imatinib-mesylate5.1%4
2
Omalizumab3.8%3
3
Naproxen2.5%2
4
Tiotropium-bromide2.5%2
5
Sofosbuvir2.5%2
6
Prednisone2.5%2
7
Amoxicillin1.3%1
8
Warfarin1.3%1
9
Omeprazole1.3%1
10
Celecoxib1.3%1
11
Lenalidomide1.3%1
12
Dexamethasone1.3%1
13
Ibuprofen1.3%1
14
Aspirin1.3%1
15
Lubiprostone1.3%1

Taken alongside

1
Albuterol22.8%18
2
Montelukast-sodium11.4%9
3
Fluticasone8.9%7
4
Ergocalciferol8.9%7
5
Omeprazole6.3%5
6
Levothyroxine-sodium6.3%5
7
Salmeterol-xinafoate5.1%4
8
Levalbuterol5.1%4
9
Furosemide5.1%4
10
Prednisone5.1%4
11
Hydrocodone5.1%4
12
Acetaminophen5.1%4
13
Fexofenadine-hydrochloride3.8%3
14
Gabapentin3.8%3
15
Losartan-potassium3.8%3

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 palovarotene side effects

58.2% of palovarotene adverse event reports involve female patients and 39.2% involve male patients. The largest age group is adult at 44%. These figures reflect who reports side effects, not underlying risk.

Sex

Female58.2%
Male39.2%
Unknown2.5%

Age group

< 20.0%
2–1116.4%
12–1710.9%
18–6443.6%
65+29.1%

What is palovarotene used for

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

AsthmaBone DisorderChronic Obstructive Pulmonary DiseaseFibrodysplasia Ossificans ProgressivaOff Label UseProduct Used For Unknown IndicationProduct Used For Unknown Indication

Palovarotene brand names and reporting trend

Palovarotene is sold under the brand name Sohonos.

Brand names

Sohonos50

Quarterly reports (20042025)

20052010201520202025

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

Taking palovarotene with another medication?

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