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Thalidomide Side Effects

The most commonly reported side effects of thalidomide include death, plasma cell myeloma, and disease progression, based on 36,209 FDA adverse event reports from 2004 to 2025. 2.7% of reports found the drug to be ineffective.

Thalidomide side effects

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

1
Death11.1%4,031
2
Plasma Cell Myeloma5.8%2,103
3
Disease Progression5.7%2,064
4
Off Label Use4.6%1,651
5
Death4.3%1,543
6
Neuropathy Peripheral3.7%1,341
7
Drug Ineffective2.7%982
8
Pneumonia2.6%928
9
Fatigue2.4%870
10
Multiple Myeloma2.4%861
11
Pneumonia2.2%805
12
Malignant Neoplasm Progression1.7%629
13
Anaemia1.7%602
14
Constipation1.7%600
15
Thrombocytopenia1.6%581

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

Report severity

88.7%Serious32,108 reports
29.9%Hospitalizations10,819 reports
31.9%Fatal11,538 reports

Seriousness is determined by the reporter, not by OpenClaim.

Thalidomide drug interactions

Other drugs that appear in adverse event reports alongside thalidomide. 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
Dexamethasone21.4%7,732
2
Bortezomib18.0%6,518
3
Cyclophosphamide9.3%3,366
4
Lenalidomide8.3%2,988
5
Melphalan5.9%2,142
6
Doxorubicin-hydrochloride5.7%2,056
7
Etoposide5.0%1,820
8
Daratumumab4.9%1,776
9
Cisplatin4.0%1,441
10
Prednisone3.4%1,221
11
Carfilzomib2.6%932
12
Pomalidomide2.5%904
13
Zoledronic-acid2.4%885
14
Methotrexate1.6%573
15
Vincristine-sulfate1.5%534

Taken alongside

1
Dexamethasone11.8%4,264
2
Aspirin5.9%2,120
3
Acyclovir4.9%1,770
4
Prednisone4.5%1,627
5
Bortezomib4.2%1,518
6
Acetaminophen4.1%1,467
7
Furosemide3.5%1,269
8
Cyclophosphamide3.4%1,226
9
Warfarin3.4%1,218
10
Omeprazole3.2%1,160
11
Pantoprazole-sodium2.9%1,053
12
Melphalan2.8%1,022
13
Oxycodone2.6%950
14
Levothyroxine-sodium2.6%941
15
Ergocalciferol2.5%895

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 thalidomide side effects

39.1% of thalidomide adverse event reports involve female patients and 50.4% involve male patients. The largest age group is elderly at 51%. These figures reflect who reports side effects, not underlying risk.

Sex

Female39.1%
Male50.4%
Unknown10.5%

Age group

< 20.2%
2–111.8%
12–171.4%
18–6445.6%
65+51.0%

What is thalidomide used for

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

5q Minus SyndromeAbdominal NeoplasmAbscessAccidental ExposureAccidental Exposure To ProductAcquired Epidermolysis BullosaAcquired Epileptic AphasiaAcquired Immunodeficiency SyndromeAcquired Von Willebrand^s DiseaseActinic PrurigoAcute Febrile Neutrophilic DermatosisAcute Graft Versus Host Disease In SkinAcute Kidney InjuryAcute LeukaemiaAcute Lymphocytic Leukaemia

Showing 15 of 1,115 indications

Thalidomide brand names and reporting trend

Thalidomide is sold under the brand name Thalomid.

Brand names

Thalomid16,823

Quarterly reports (20042025)

20052010201520202025

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

Taking thalidomide with another medication?

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