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Leflunomide Adverse Events Reported to the FDA Over Time

How are Leflunomide adverse event reports trending over time?

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

Most Common Leflunomide Adverse Events Reported to the FDA

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

Dyspnoea
82 (1.52%)
Diarrhoea
75 (1.39%)
Pyrexia
68 (1.26%)
Drug Exposure During Pregnancy
61 (1.13%)
Pneumonia
57 (1.06%)
Alanine Aminotransferase Increased
54 (1%)
Sepsis
49 (.91%)
Pancytopenia
48 (.89%)
Respiratory Failure
45 (.83%)
Anaemia
43 (.8%)
Rash
43 (.8%)
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Weight Decreased
43 (.8%)
Aspartate Aminotransferase Increase...
40 (.74%)
Renal Failure Acute
39 (.72%)
Asthenia
38 (.7%)
Nausea
37 (.69%)
Hepatic Failure
35 (.65%)
Leukopenia
35 (.65%)
Thrombocytopenia
33 (.61%)
Fatigue
32 (.59%)
General Physical Health Deteriorati...
32 (.59%)
Liver Function Test Abnormal
32 (.59%)
Arthralgia
31 (.57%)
Drug Interaction
31 (.57%)
Cardiac Failure
30 (.56%)
Hepatic Enzyme Increased
30 (.56%)
Lung Neoplasm
28 (.52%)
Rheumatoid Arthritis
28 (.52%)
Hypertension
27 (.5%)
Condition Aggravated
26 (.48%)
Drug Ineffective
25 (.46%)
Pneumonitis
25 (.46%)
Abdominal Pain
24 (.44%)
Oedema Peripheral
24 (.44%)
Vomiting
24 (.44%)
Chest Pain
23 (.43%)
Headache
23 (.43%)
Hepatic Function Abnormal
23 (.43%)
Blood Alkaline Phosphatase Increase...
22 (.41%)
Cellulitis
22 (.41%)
Cough
22 (.41%)
Dizziness
22 (.41%)
Hepatotoxicity
22 (.41%)
Multi-organ Failure
22 (.41%)
Jaundice
21 (.39%)
Renal Failure
21 (.39%)
Septic Shock
21 (.39%)
Death
20 (.37%)
Lung Infiltration
20 (.37%)
Vasculitic Rash
20 (.37%)
Blood Pressure Increased
19 (.35%)
Erythema Multiforme
19 (.35%)
Off Label Use
19 (.35%)
Back Pain
18 (.33%)
Blood Lactate Dehydrogenase Increas...
18 (.33%)
Bursitis
18 (.33%)
Cerebrovascular Accident
18 (.33%)
Infection
18 (.33%)
Interstitial Lung Disease
18 (.33%)
Paraesthesia
18 (.33%)
Progressive Multifocal Leukoencepha...
18 (.33%)
Rectal Haemorrhage
18 (.33%)
Acute Respiratory Distress Syndrome
17 (.31%)
Coagulopathy
17 (.31%)
Histiocytosis Haematophagic
17 (.31%)
Pleural Effusion
17 (.31%)
White Blood Cell Count Decreased
17 (.31%)
Chills
16 (.3%)
Gamma-glutamyltransferase Increased
16 (.3%)
Pulmonary Fibrosis
16 (.3%)
Breast Cancer
15 (.28%)
Lymphadenopathy
15 (.28%)
Malaise
15 (.28%)
Pain
15 (.28%)
Pregnancy
15 (.28%)
Pulmonary Embolism
15 (.28%)
Tubulointerstitial Nephritis
15 (.28%)
Decreased Appetite
14 (.26%)
Dehydration
14 (.26%)
Delirium
14 (.26%)
Dysphagia
14 (.26%)
Fall
14 (.26%)
Myelodysplastic Syndrome
14 (.26%)
Myocardial Infarction
14 (.26%)
Pain In Extremity
14 (.26%)
Vision Blurred
14 (.26%)
Bone Marrow Toxicity
13 (.24%)
C-reactive Protein Increased
13 (.24%)
Ischaemic Stroke
13 (.24%)
Loss Of Consciousness
13 (.24%)
Polyneuropathy
13 (.24%)
Acute Hepatic Failure
12 (.22%)
Blood Creatinine Increased
12 (.22%)
Disseminated Tuberculosis
12 (.22%)
Gastrointestinal Haemorrhage
12 (.22%)
Impaired Healing
12 (.22%)
Infarction
12 (.22%)
Lethargy
12 (.22%)
Lung Disorder
12 (.22%)
Neutropenic Sepsis
12 (.22%)
Skin Necrosis
12 (.22%)

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This graph shows the top adverse events submitted to the FDA for Leflunomide, 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 Leflunomide 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 Leflunomide

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

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This graph shows the top categories of adverse events submitted to the FDA for Leflunomide, 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 Leflunomide 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 Leflunomide According to Those Reporting Adverse Events

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

Rheumatoid Arthritis
2310
Drug Use For Unknown Indication
802
Product Used For Unknown Indication
350
Psoriatic Arthropathy
108
Arthritis
89
Juvenile Arthritis
33
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Polyarthritis
24
Musculoskeletal Pain
12
Seronegative Arthritis
12
Ankylosing Spondylitis
11
Wegeners Granulomatosis
11
Antiinflammatory Therapy
11
Systemic Lupus Erythematosus
10
Bk Virus Infection
9
Psoriasis
9
Pain
8
Ill-defined Disorder
6
Lupus Nephritis
5
Inflammation
5
Uveitis
5
Immunosuppression
5
Polyomavirus-associated Nephropathy
5
Hypertension
4
Arthropathy
4
Spondyloarthropathy
4
Sjogrens Syndrome
4
Synovitis
3
Stills Disease Adult Onset
3
Dyspnoea
3
Crohns Disease
3
Polymyalgia Rheumatica
3
Diarrhoea
3
Arthralgia
3
Cytomegalovirus Infection
2
Osteoarthritis
2
Cytomegalovirus Viraemia
2
Prostatic Specific Antigen
2
Tuberculosis
2
Immunomodulatory Therapy
2
Immune System Disorder
2
Immunosuppressant Drug Therapy
2
Asthenia
2
Paraesthesia
1
Prostate Cancer
1
Pustular Psoriasis
1
Nephrotic Syndrome
1
Nephropathy
1
Drug Exposure During Pregnancy
1
Behcets Syndrome
1
Fatigue
1
Prophylaxis
1

Drug Labels

LabelLabelerEffective
LeflunomidePhysicians Total Care, Inc.26-JUN-09
LeflunomideHeritage Pharmaceuticals Inc27-OCT-10
LeflunomideSandoz Inc20-OCT-11
LeflunomideNorthStar RxLLC02-DEC-11
LeflunomideGolden State Medical Supply, Inc.09-JAN-12
LeflunomidePrasco LLC31-AUG-12
Aravasanofi-aventis U.S. LLC14-NOV-12
LeflunomideTeva Pharmaceuticals USA Inc07-DEC-12
LeflunomideApotex Corp. 16-JAN-13
AravaBryant Ranch Prepack17-JAN-13

Leflunomide Case Reports

What Leflunomide 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 Leflunomide. 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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