How are Simvastatin adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Simvastatin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Simvastatin is flagged as the suspect drug causing the adverse event.
What are the most common Simvastatin adverse events reported to the FDA?
Rhabdomyolysis | 1983 (4.43%) |
Myalgia | 1368 (3.06%) |
Drug Interaction | 1253 (2.8%) |
Renal Failure Acute | 783 (1.75%) |
Blood Creatine Phosphokinase Increa... | 712 (1.59%) |
Muscular Weakness | 632 (1.41%) |
Asthenia | 515 (1.15%) |
Fatigue | 493 (1.1%) |
Pain In Extremity | 484 (1.08%) |
Alanine Aminotransferase Increased | 406 (.91%) |
Arthralgia | 405 (.91%) |
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This graph shows the top adverse events submitted to the FDA for Simvastatin, 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 Simvastatin 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.
What are the most common Simvastatin adverse events reported to the FDA?
Muscle | 5403 (12.08%) |
Neurological | 1751 (3.91%) |
Therapeutic And Nontherapeutic Effe... | 1622 (3.62%) |
Renal Disorders | 1478 (3.3%) |
Hepatobiliary | 1454 (3.25%) |
Gastrointestinal Signs | 1443 (3.22%) |
Epidermal And Dermal Conditions | 1430 (3.2%) |
Respiratory | 1192 (2.66%) |
Musculoskeletal And Connective Tiss... | 1111 (2.48%) |
Enzyme | 956 (2.14%) |
Hepatic And Hepatobiliary | 843 (1.88%) |
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This graph shows the top categories of adverse events submitted to the FDA for Simvastatin, 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 Simvastatin 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.
Why are people taking Simvastatin, according to those reporting adverse events to the FDA?
Blood Cholesterol Increased | 6167 |
Product Used For Unknown Indication | 5266 |
Hypercholesterolaemia | 3832 |
Drug Use For Unknown Indication | 3078 |
Hyperlipidaemia | 2823 |
Blood Cholesterol | 1822 |
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Label | Labeler | Effective |
---|---|---|
Simvastatin | Bryant Ranch Prepack | 26-FEB-08 |
Simvastatin | Cobalt Laboratories Inc. | 04-DEC-09 |
Simvastatin | Cobalt Laboratories Inc. | 02-FEB-10 |
Simvastatin | State of Florida DOH Central Pharmacy | 12-APR-10 |
Simvastatin | State of Florida DOH Central Pharmacy | 13-APR-10 |
Simvastatin | State of Florida DOH Central Pharmacy | 13-APR-10 |
Simvastatin | UDL Laboratories, Inc. | 04-JUN-10 |
Simvastatin | Contract Pharmacy Services-PA | 17-JUN-10 |
Simcor | Physicians Total Care, Inc. | 06-AUG-10 |
Simvastatin | Contract Pharmacy Services-PA | 25-AUG-10 |
Simvastatin | MedVantx, Inc. | 14-SEP-10 |
Simvastatin | MedVantx, Inc. | 14-SEP-10 |
Simvastatin | REMEDYREPACK INC. | 21-SEP-10 |
Simvastatin | Lupin Pharmaceuticals, Inc. | 03-NOV-10 |
Simvastatin | Rebel Distributors Corp | 01-DEC-10 |
Vytorin | Rebel Distributors Corp | 01-DEC-10 |
Simvastatin | Unit Dose Services | 15-MAR-11 |
Simvastatin | Unit Dose Services | 15-MAR-11 |
Simvastatin | Unit Dose Services | 15-MAR-11 |
Simvastatin | REMEDYREPACK INC. | 14-APR-11 |
Simvastatin | Cardinal Health | 09-JUN-11 |
Simvastatin | PD-Rx Pharmaceuticals, Inc. | 13-JUN-11 |
Simvastatin | PD-Rx Pharmaceuticals, Inc. | 13-JUN-11 |
Simvastatin | REMEDYREPACK INC. | 08-JUL-11 |
Simvastatin | REMEDYREPACK INC. | 15-JUL-11 |
Simvastatin | REMEDYREPACK INC. | 25-JUL-11 |
Simvastatin | REMEDYREPACK INC. | 01-AUG-11 |
Zocor | Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC | 08-AUG-11 |
Simvastatin | St Marys Medical Park Pharmacy | 08-SEP-11 |
Simvastatin | REMEDYREPACK INC. | 09-SEP-11 |
Vytorin | PD-Rx Pharmaceuticals, Inc. | 01-NOV-11 |
Simvastatin | PD-Rx Pharmaceuticals, Inc. | 10-NOV-11 |
Simvastatin | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 23-NOV-11 |
Simvastatin | NCS HealthCare of KY, Inc dba Vangard Labs | 30-NOV-11 |
Simvastatin | REMEDYREPACK INC. | 08-DEC-11 |
Simvastatin | Legacy Pharmaceutical Packaging | 13-DEC-11 |
Simvastatin | H.J. Harkins Company, Inc. | 14-DEC-11 |
Simvastatin | Rebel Distributors Corp | 27-DEC-11 |
Simvastatin | McKesson Packaging Services a business unit of McKesson Corporation | 17-JAN-12 |
Vytorin | PD-Rx Pharmaceuticals, Inc. | 24-JAN-12 |
Simvastatin | Mylan Pharmaceuticals Inc. | 01-MAR-12 |
Simvastatin | Life Line Home Care Services, Inc. | 12-MAR-12 |
Simvastatin | Ingenus Pharmaceuticals, LLC | 21-MAR-12 |
Simvastatin | Preferred Pharmaceuticals, Inc | 29-MAR-12 |
Simvastatin | H.J. Harkins Company, Inc. | 17-APR-12 |
Simvastatin | McKesson Contract Packaging | 11-MAY-12 |
Simvastatin | Aurolife Pharma LLC | 29-MAY-12 |
Simvastatin | American Health Packaging | 04-JUN-12 |
Simvastatin | Aphena Pharma Solutions - Tennessee, Inc. | 14-AUG-12 |
Simvastatin | Major Pharmaceuticals | 15-AUG-12 |
Simvastatin | Legacy Pharmaceutical Packaging | 28-AUG-12 |
Simvastatin | Physicians Total Care, Inc. | 05-SEP-12 |
Vytorin | Physicians Total Care, Inc. | 06-SEP-12 |
Simvastatin | Preferred Pharmaceuticals, Inc | 20-SEP-12 |
Simvastatin | NCS HealthCare of KY, Inc dba Vangard Labs | 10-OCT-12 |
Simvastatin | Bryant Ranch Prepack | 12-OCT-12 |
Zocor | Merck Sharp & Dohme Corp. | 31-OCT-12 |
Simvastatin | Accord Healthcare Inc. | 01-NOV-12 |
Simvastatin | Lake Erie Medical DBA Quality Care Products LLC | 13-NOV-12 |
Simvastatin | Aurobindo Pharma Limited | 14-NOV-12 |
Simvastatin | Micro Labs Limited | 16-NOV-12 |
Simvastatin | Ranbaxy Pharmaceuticals Inc. | 29-NOV-12 |
Simvastatin | Teva Pharmaceuticals USA Inc | 10-DEC-12 |
Simvastatin | PD-Rx Pharmaceuticals, Inc. | 10-DEC-12 |
Simvastatin | International Labs, Inc. | 14-DEC-12 |
Simvastatin | Dr. Reddy's Laboratories Limited | 18-DEC-12 |
Simvastatin | NorthStar Rx LLC | 21-DEC-12 |
Simvastatin | McKesson Packaging Services a business unit of McKesson Corporation | 11-JAN-13 |
Simvastatin | Bryant Ranch Prepack | 17-JAN-13 |
Simvastatin | Bryant Ranch Prepack | 21-JAN-13 |
Simvastatin | Mylan Institutional Inc. | 08-FEB-13 |
Simvastatin | KAISER FOUNDATION HOSPITALS | 08-FEB-13 |
Juvisync | Merck Sharp & Dohme Corp. | 11-FEB-13 |
Vytorin | Merck Sharp & Dohme Corp. | 13-FEB-13 |
Simvastatin | Lake Erie Medical DBA Quality Care Products LLC | 14-FEB-13 |
Simvastatin | REMEDYREPACK INC. | 19-FEB-13 |
Simcor | AbbVie Inc. | 27-FEB-13 |
Simvastatin | Zydus Pharmaceuticals (USA) Inc. | 07-MAR-13 |
Simvastatin | Cadila Healthcare Limited | 16-MAR-13 |
Simvastatin | McKesson Contract Packaging | 20-MAR-13 |
Simvastatin | Micro Labs Limited | 23-MAR-13 |
Simvastatin | Cardinal Health | 28-MAR-13 |
Simvastatin | Blu Pharmaceuticals, LLC | 04-APR-13 |
Simvastatin | Cardinal Health | 17-APR-13 |
Simvastatin | International Labs, Inc. | 30-APR-13 |
Simvastatin | REMEDYREPACK INC. | 01-MAY-13 |
What Simvastatin safety concerns are being reported by doctors and researchers in the medical literature?
This report contains aggregated drug side effects and adverse events for Simvastatin. 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.
Share your experience with Simvastatin.