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Thalidomide Adverse Events Reported to the FDA Over Time

How are Thalidomide adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Thalidomide, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Thalidomide is flagged as the suspect drug causing the adverse event.

Most Common Thalidomide Adverse Events Reported to the FDA

What are the most common Thalidomide adverse events reported to the FDA?

Pneumonia
297 (1.52%)
Death
293 (1.5%)
Neuropathy Peripheral
260 (1.33%)
Disease Progression
257 (1.32%)
Multiple Myeloma
245 (1.26%)
Anaemia
224 (1.15%)
Pyrexia
218 (1.12%)
Neutropenia
210 (1.08%)
Pulmonary Embolism
205 (1.05%)
Fatigue
203 (1.04%)
Constipation
201 (1.03%)
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Thrombocytopenia
191 (.98%)
Dyspnoea
189 (.97%)
Deep Vein Thrombosis
179 (.92%)
Infection
172 (.88%)
Asthenia
164 (.84%)
Sepsis
161 (.83%)
Nausea
156 (.8%)
Renal Failure
155 (.8%)
Diarrhoea
152 (.78%)
Somnolence
140 (.72%)
General Physical Health Deteriorati...
126 (.65%)
Dizziness
124 (.64%)
Pancytopenia
114 (.58%)
Pleural Effusion
113 (.58%)
Febrile Neutropenia
112 (.57%)
Vomiting
111 (.57%)
Hypotension
106 (.54%)
Respiratory Failure
104 (.53%)
Atrial Fibrillation
101 (.52%)
Rash
101 (.52%)
Dehydration
99 (.51%)
Cardiac Failure
94 (.48%)
Haemoglobin Decreased
94 (.48%)
Pain
91 (.47%)
Fall
89 (.46%)
Oedema Peripheral
88 (.45%)
Renal Failure Acute
84 (.43%)
Peripheral Sensory Neuropathy
83 (.43%)
Decreased Appetite
81 (.42%)
Septic Shock
81 (.42%)
Syncope
79 (.41%)
Cardiac Disorder
77 (.4%)
Confusional State
77 (.4%)
Drug Ineffective
77 (.4%)
Platelet Count Decreased
75 (.38%)
Bradycardia
72 (.37%)
Malignant Neoplasm Progression
72 (.37%)
Acute Myeloid Leukaemia
67 (.34%)
White Blood Cell Count Decreased
67 (.34%)
Back Pain
62 (.32%)
Headache
62 (.32%)
Hypoaesthesia
61 (.31%)
Mucosal Inflammation
61 (.31%)
Myocardial Infarction
58 (.3%)
Chest Pain
57 (.29%)
Leukopenia
57 (.29%)
Cardiac Failure Congestive
56 (.29%)
Oedema
55 (.28%)
Hypertension
54 (.28%)
Interstitial Lung Disease
54 (.28%)
Paraesthesia
54 (.28%)
Blood Creatinine Increased
53 (.27%)
Gastrointestinal Inflammation
52 (.27%)
Thrombosis
52 (.27%)
Condition Aggravated
51 (.26%)
Myelodysplastic Syndrome
51 (.26%)
No Therapeutic Response
51 (.26%)
Bone Marrow Failure
50 (.26%)
Hypoxia
50 (.26%)
Sinusitis
50 (.26%)
Tremor
50 (.26%)
Loss Of Consciousness
49 (.25%)
Osteonecrosis
49 (.25%)
Anxiety
48 (.25%)
Cellulitis
47 (.24%)
Weight Decreased
47 (.24%)
Abdominal Pain
46 (.24%)
Cerebrovascular Accident
46 (.24%)
Multi-organ Failure
46 (.24%)
Renal Impairment
46 (.24%)
Cardio-respiratory Arrest
45 (.23%)
Cough
45 (.23%)
Plasmacytoma
45 (.23%)
Polyneuropathy
44 (.23%)
Convulsion
43 (.22%)
Drug Toxicity
43 (.22%)
Cardiac Arrest
41 (.21%)
Pneumonitis
41 (.21%)
Pulmonary Oedema
41 (.21%)
Bronchopneumonia
40 (.21%)
Depression
39 (.2%)
Haematocrit Decreased
39 (.2%)
Lung Infection
39 (.2%)
Malaise
39 (.2%)
Sudden Death
39 (.2%)
Atelectasis
38 (.19%)
Haemorrhage
38 (.19%)
Oesophagitis
38 (.19%)
Colitis
37 (.19%)
Drug Interaction
37 (.19%)

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This graph shows the top adverse events submitted to the FDA for Thalidomide, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Thalidomide is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Thalidomide

What are the most common Thalidomide adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Thalidomide, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Thalidomide is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Thalidomide According to Those Reporting Adverse Events

Why are people taking Thalidomide, according to those reporting adverse events to the FDA?

Multiple Myeloma
3522
Drug Use For Unknown Indication
109
Myelodysplastic Syndrome
87
Prostate Cancer
68
Plasmacytoma
53
Non-small Cell Lung Cancer
47
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Prostatic Intraepithelial Neoplasia
46
Glioblastoma Multiforme
40
Product Used For Unknown Indication
35
Myelofibrosis
34
Mantle Cell Lymphoma
23
Acute Myeloid Leukaemia
22
Small Cell Lung Cancer Stage Unspec...
22
Renal Cell Carcinoma Stage Unspecif...
20
Leukaemia Plasmacytic
20
Behcets Syndrome
18
Amyloidosis
16
Chemotherapy
16
Waldenstroms Macroglobulinaemia
16
Amyotrophic Lateral Sclerosis
16
Juvenile Arthritis
14
Malignant Melanoma
14
Prostate Cancer Metastatic
14
Pyoderma Gangrenosum
14
Metastatic Malignant Melanoma
13
Crohns Disease
12
Brain Neoplasm
12
Medulloblastoma
11
Hepatic Neoplasm Malignant
10
Metastatic Renal Cell Carcinoma
9
Systemic Lupus Erythematosus
9
Myeloid Leukaemia
9
Renal Cell Carcinoma
7
Ill-defined Disorder
7
Type 2 Lepra Reaction
7
Cutaneous Lupus Erythematosus
7
Metastases To Central Nervous Syste...
6
Anaplastic Astrocytoma
6
Febrile Neutropenia
6
Graft Versus Host Disease
6
Renal Cancer Metastatic
5
Ependymoma
5
Glioblastoma
5
Ovarian Cancer
5
Leprosy
5
Chronic Lymphocytic Leukaemia
4
Kaposis Sarcoma
4
Immunosuppressant Drug Therapy
4
Aphthous Stomatitis
4
Ankylosing Spondylitis
4
Lichen Planus
4

Drug Labels

LabelLabelerEffective
ThalomidCelgene Corporation18-FEB-13

Thalidomide Case Reports

What Thalidomide safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Thalidomide. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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