PHENOBARBITAL
Phenobarbital Adverse Events Reported to the FDA Over Time
How are Phenobarbital adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Phenobarbital, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Phenobarbital is flagged as the suspect drug causing the adverse event.
Most Common Phenobarbital Adverse Events Reported to the FDA
What are the most common Phenobarbital adverse events reported to the FDA?
| Convulsion | 184 (2.37%) |
| Completed Suicide | 163 (2.1%) |
| Drug Rash With Eosinophilia And Sys... | 133 (1.71%) |
| Drug Ineffective | 103 (1.33%) |
| Pyrexia | 102 (1.31%) |
| Drug Exposure During Pregnancy | 88 (1.13%) |
| Drug Interaction | 86 (1.11%) |
| Overdose | 82 (1.06%) |
| Somnolence | 61 (.79%) |
| Grand Mal Convulsion | 57 (.73%) |
| Stevens-johnson Syndrome | 56 (.72%) |
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This graph shows the top adverse events submitted to the FDA for Phenobarbital, 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 Phenobarbital 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 Phenobarbital
What are the most common Phenobarbital adverse events reported to the FDA?
| Epidermal And Dermal Conditions | 497 (6.41%) |
| Neurological | 462 (5.95%) |
| Seizures | 389 (5.01%) |
| Medication Errors | 285 (3.67%) |
| Therapeutic And Nontherapeutic Effe... | 261 (3.36%) |
| Suicidal And Self-injurious Behavio... | 224 (2.89%) |
| Respiratory | 211 (2.72%) |
| Hematology Investigations | 198 (2.55%) |
| Chemical Injury And Poisoning | 197 (2.54%) |
| Cardiac Arrhythmias | 160 (2.06%) |
| Hepatic And Hepatobiliary | 153 (1.97%) |
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Share/Embed Graph Export Data
This graph shows the top categories of adverse events submitted to the FDA for Phenobarbital, 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 Phenobarbital 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 Phenobarbital According to Those Reporting Adverse Events
Why are people taking Phenobarbital, according to those reporting adverse events to the FDA?
| Epilepsy | 822 |
| Convulsion | 675 |
| Drug Use For Unknown Indication | 321 |
| Product Used For Unknown Indication | 259 |
| Irritable Bowel Syndrome | 80 |
| Convulsion Prophylaxis | 79 |
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Drug Labels
| Label | Labeler | Effective |
|---|---|---|
| Phenobarbital | Bryant Ranch Prepack | 01-JAN-00 |
| Phenobarbital | McKesson Packaging Services Business Unit of McKesson Corporation | 17-DEC-09 |
| Phenobarbital | UDL Laboratories, Inc. | 10-SEP-10 |
| Re-pb Hyos Elixir | Rebel Distributors Corp | 26-JAN-11 |
| Phenobarbital | Cardinal Health | 26-APR-11 |
| Phenobarbital | Pack Pharmaceuticals, LLC | 09-JUL-11 |
| Phenobarbital Sodium | West-ward Pharmaceutical Corp. | 08-AUG-11 |
| Phenobarbital | PD-Rx Pharmaceuticals, Inc. | 24-JAN-12 |
| Phenobarbital | Qualitest Pharmaceuticals | 25-JAN-12 |
| Phenobarbital | Atlantic Biologicals Corps | 25-JAN-12 |
| Phenobarbital | Contract Pharmacy Services-PA | 07-FEB-12 |
| Phenobarbital | Qualitest Pharmaceuticals | 03-AUG-12 |
| Phenobarbital | McKesson Contract Packaging | 14-SEP-12 |
| Phenobarbital | C.O. Truxton, Inc. | 17-OCT-12 |
| Phenobarbital | West-Ward Pharmaceutical Corp | 18-APR-13 |
| Phenobarbital | Aphena Pharma Solutions - Tennessee, Inc. | 02-MAY-13 |
Phenobarbital Case Reports
What Phenobarbital 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 Phenobarbital. 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.
Comments
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