How are Baclofen adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Baclofen, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Baclofen is flagged as the suspect drug causing the adverse event.
What are the most common Baclofen adverse events reported to the FDA?
Completed Suicide | 226 (1.84%) |
Overdose | 204 (1.66%) |
Coma | 197 (1.6%) |
Convulsion | 155 (1.26%) |
Confusional State | 147 (1.2%) |
Muscle Spasticity | 132 (1.07%) |
Somnolence | 127 (1.03%) |
Muscle Spasms | 122 (.99%) |
Drug Withdrawal Syndrome | 121 (.98%) |
Hypotension | 118 (.96%) |
Cardiac Arrest | 115 (.94%) |
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This graph shows the top adverse events submitted to the FDA for Baclofen, 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 Baclofen 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 Baclofen adverse events reported to the FDA?
Neurological | 1299 (10.57%) |
Medication Errors | 515 (4.19%) |
Respiratory | 474 (3.86%) |
Cardiac Arrhythmias | 450 (3.66%) |
Therapeutic And Nontherapeutic Effe... | 391 (3.18%) |
Suicidal And Self-injurious Behavio... | 368 (3%) |
Infections - Pathogen Unspecified | 367 (2.99%) |
Gastrointestinal Signs | 350 (2.85%) |
Deliria | 318 (2.59%) |
Muscle | 306 (2.49%) |
Procedural And Device Related Injur... | 302 (2.46%) |
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This graph shows the top categories of adverse events submitted to the FDA for Baclofen, 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 Baclofen 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 Baclofen, according to those reporting adverse events to the FDA?
Muscle Spasticity | 1374 |
Muscle Spasms | 1021 |
Product Used For Unknown Indication | 566 |
Drug Use For Unknown Indication | 498 |
Multiple Sclerosis | 334 |
Pain | 250 |
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Label | Labeler | Effective |
---|---|---|
Baclofen | Bryant Ranch Rrepack | 01-JUL-07 |
Baclofen | McKesson Packaging Services Business Unit of McKesson Corporation | 01-DEC-09 |
Baclofen | Rebel Distributors Corp. | 01-DEC-09 |
Baclofen | UDL Laboratories, Inc. | 22-JUN-10 |
Baclofen | STAT RX USA LLC | 29-JUN-10 |
Baclofen | Unit Dose Services | 15-JUL-10 |
Baclofen | Unit Dose Services | 15-JUL-10 |
Baclofen | PD-Rx Pharmaceuticals, Inc. | 15-JUL-10 |
Baclofen | Med Health Pharma, LLC | 01-JAN-11 |
Baclofen | Lannett Company, Inc. | 18-JAN-11 |
Baclofen | McKesson Packaging Services Business Unit of McKesson Corporation | 28-MAR-11 |
Baclofen | REMEDYREPACK INC. | 04-APR-11 |
Baclofen | American Health Packaging | 21-APR-11 |
Baclofen | Preferred Pharmaceuticals, Inc | 06-JUN-11 |
Baclofen | PD-Rx Pharmaceuticals, Inc. | 01-AUG-11 |
Baclofen | Cardinal Health | 30-SEP-11 |
Baclofen | REMEDYREPACK INC. | 10-OCT-11 |
Baclofen | Lake Erie Medical DBA Quality Care Products LLC | 10-NOV-11 |
Baclofen | Lake Erie Medical DBA Quality Care Products LLC | 10-NOV-11 |
Baclofen | H.J. Harkins Company, Inc. | 13-DEC-11 |
Baclofen | McKesson Contract Packaging | 20-DEC-11 |
Baclofen | Rebel Distributors Corp | 27-DEC-11 |
Baclofen | Mylan Pharmaceuticals Inc. | 01-FEB-12 |
Baclofen | NCS HealthCare of KY, Inc dba Vangard Labs | 21-FEB-12 |
Baclofen | REMEDYREPACK INC. | 13-MAR-12 |
Baclofen | REMEDYREPACK INC. | 15-MAR-12 |
Baclofen | Preferred Pharmaceuticals, Inc | 28-MAR-12 |
Baclofen | Upsher-Smith Laboratories, Inc. | 19-JUN-12 |
Baclofen | Major Pharmaceuticals | 02-AUG-12 |
Baclofen | Cardinal Health | 07-AUG-12 |
Baclofen | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 08-AUG-12 |
Baclofen | Physicians Total Care, Inc. | 05-SEP-12 |
Baclofen | American Health Packaging | 06-SEP-12 |
Baclofen | Preferred Pharmaceuticals, Inc | 17-OCT-12 |
Baclofen | Qualitest Pharmaceuticals | 28-NOV-12 |
Baclofen | Northstar RxLLC | 15-JAN-13 |
Baclofen | REMEDYREPACK INC. | 11-FEB-13 |
Baclofen | IVAX Pharmaceuticals, Inc. | 14-FEB-13 |
Gablofen | CNS Therapeutics, Inc. | 26-MAR-13 |
What Baclofen safety concerns are being reported by doctors and researchers in the medical literature?
This report contains aggregated drug side effects and adverse events for Baclofen. 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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