NALTREXONE
Naltrexone Adverse Events Reported to the FDA Over Time
How are Naltrexone adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Naltrexone, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Naltrexone is flagged as the suspect drug causing the adverse event.
Most Common Naltrexone Adverse Events Reported to the FDA
What are the most common Naltrexone adverse events reported to the FDA?
| Drug Ineffective | 125 (3.87%) |
| Headache | 115 (3.56%) |
| Nausea | 103 (3.19%) |
| Drug Withdrawal Syndrome | 83 (2.57%) |
| Vomiting | 67 (2.08%) |
| Insomnia | 56 (1.74%) |
| Withdrawal Syndrome | 52 (1.61%) |
| Diarrhoea | 51 (1.58%) |
| Pain | 48 (1.49%) |
| Hyperhidrosis | 45 (1.39%) |
| Malaise | 45 (1.39%) |
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This graph shows the top adverse events submitted to the FDA for Naltrexone, 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 Naltrexone 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 Naltrexone
What are the most common Naltrexone adverse events reported to the FDA?
| Gastrointestinal Signs | 288 (8.93%) |
| Therapeutic And Nontherapeutic Effe... | 261 (8.09%) |
| Neurological | 202 (6.26%) |
| Headaches | 132 (4.09%) |
| Epidermal And Dermal Conditions | 121 (3.75%) |
| Psychiatric | 111 (3.44%) |
| Respiratory | 100 (3.1%) |
| Anxiety Disorders | 84 (2.6%) |
| Sleep Disorders | 75 (2.32%) |
| Gastrointestinal Motility And Defec... | 74 (2.29%) |
| Skin Appendage Conditions | 72 (2.23%) |
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This graph shows the top categories of adverse events submitted to the FDA for Naltrexone, 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 Naltrexone 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 Naltrexone According to Those Reporting Adverse Events
Why are people taking Naltrexone, according to those reporting adverse events to the FDA?
| Back Pain | 128 |
| Pain | 122 |
| Alcoholism | 46 |
| Product Used For Unknown Indication | 46 |
| Drug Use For Unknown Indication | 33 |
| Drug Detoxification | 31 |
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Drug Labels
| Label | Labeler | Effective |
|---|---|---|
| Vivitrol | Alkermes, Inc. | 18-OCT-10 |
| Vivitrol | Alkermes, Inc. | 18-OCT-10 |
| Naltrexone Hydrochloride | Mallinckrodt Inc. | 06-APR-11 |
| Naltrexone Hydrochloride | Accord Healthcare, Inc., | 30-AUG-11 |
| Naltrexone Hydrochloride | Sun Pharma Global FZE | 28-FEB-12 |
| Naltrexone Hydrochloride | Physicians Total Care, Inc. | 01-MAY-12 |
| Naltrexone Hydrochloride | American Health Packaging | 31-MAY-12 |
| Embeda | King Pharmaceuticals Inc. | 16-JUL-12 |
| Revia | Teva Women's Health, Inc | 14-AUG-12 |
| Naltrexone Hydrochloride | Barr Laboratories Inc. | 22-AUG-12 |
| Naltrexone Hydrochloride | Unit Dose Services | 22-AUG-12 |
| Naltrexone Hydrochloride | Eon Labs, Inc. | 20-MAR-13 |
Naltrexone Case Reports
What Naltrexone 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 Naltrexone. 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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