Drug Safety Information for THALOMID (Thalidomide)

REMS for Thalomid (THALIDOMIDE) Rx Drug: Safety Information Link

FDA Risk Evaluation and Mitigation Strategy REMS

FDA Safety-related Labeling Changes for THALOMID (THALIDOMIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for THALOMID* (Thalidomide)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with THALOMID
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death5639
2Disease progression2324
3Pneumonia1143
4Neuropathy peripheral1074
5Multiple myeloma974
6Neoplasm malignant890
7Fatigue846
8Dyspnoea793
9Asthenia750
10Deep vein thrombosis706
11Anaemia703
12Pyrexia689
13Renal failure669
14Constipation*631
15Osteonecrosis596
16Nausea588
17Pulmonary embolism575
18Sepsis547
19Diarrhoea515
20Oedema peripheral510

* This side effect also appears in "Top 10 Side Effects of THALOMID " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking THALOMID
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Multiple myeloma*38370
2Product used for unknown indication2178
3Myelodysplastic syndrome2118
4Prostate cancer1102
5Malignant melanoma909
6Renal cell carcinoma744
7Myelofibrosis721
8Metastatic malignant melanoma657
9Glioblastoma multiforme624
10Non-small cell lung cancer483

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for THALOMID

Total Reports Filed with FDA: 83386


Number of FDA Adverse Event Reports by Patient Age for THALOMID

Total Reports Filed with FDA: 83386*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Thalidomide (Thalomid)

Charts are based on 83386 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and THALOMID Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.