TYSABRI
Tysabri Adverse Events Reported to the FDA Over Time
How are Tysabri adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Tysabri, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Tysabri is flagged as the suspect drug causing the adverse event.
Most Common Tysabri Adverse Events Reported to the FDA
What are the most common Tysabri adverse events reported to the FDA?
| Fatigue | 13392 (4.32%) |
| Multiple Sclerosis Relapse | 11015 (3.55%) |
| Headache | 6914 (2.23%) |
| Gait Disturbance | 6249 (2.02%) |
| Fall | 6186 (1.99%) |
| Asthenia | 5792 (1.87%) |
| Urinary Tract Infection | 5129 (1.65%) |
| Multiple Sclerosis | 4998 (1.61%) |
| Drug Ineffective | 4461 (1.44%) |
| Balance Disorder | 4257 (1.37%) |
| Memory Impairment | 4047 (1.3%) |
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This graph shows the top adverse events submitted to the FDA for Tysabri, 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 Tysabri 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 Tysabri
What are the most common Tysabri adverse events reported to the FDA?
| Neurological | 23588 (7.61%) |
| Infections - Pathogen Unspecified | 21989 (7.09%) |
| Demyelinating | 16646 (5.37%) |
| Musculoskeletal And Connective Tiss... | 12515 (4.04%) |
| Injuries | 10916 (3.52%) |
| Headaches | 8487 (2.74%) |
| Mental Impairment | 8229 (2.65%) |
| Muscle | 7837 (2.53%) |
| Gastrointestinal Signs | 7805 (2.52%) |
| Viral Infectious | 7226 (2.33%) |
| Epidermal And Dermal Conditions | 6446 (2.08%) |
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Share/Embed Graph Export Data
This graph shows the top categories of adverse events submitted to the FDA for Tysabri, 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 Tysabri 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 Tysabri According to Those Reporting Adverse Events
Why are people taking Tysabri, according to those reporting adverse events to the FDA?
| Multiple Sclerosis | 89088 |
| Relapsing-remitting Multiple Sclero... | 2227 |
| Crohns Disease | 1181 |
| Product Used For Unknown Indication | 620 |
| Drug Exposure During Pregnancy | 198 |
| Drug Use For Unknown Indication | 122 |
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Drug Labels
| Label | Labeler | Effective |
|---|---|---|
| Tysabri | Elan Pharmaceuticals, Inc. | 21-DEC-12 |
Tysabri Case Reports
What Tysabri safety concerns are being reported by doctors and researchers in the medical literature?
About Results
This report contains aggregated drug side effects and adverse events for Tysabri. 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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