How are Terbinafine adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Terbinafine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Terbinafine is flagged as the suspect drug causing the adverse event.
What are the most common Terbinafine adverse events reported to the FDA?
Aspartate Aminotransferase Increase... | 413 (1.84%) |
Alanine Aminotransferase Increased | 406 (1.81%) |
Pyrexia | 319 (1.42%) |
Pruritus | 298 (1.33%) |
Rash | 290 (1.29%) |
Gamma-glutamyltransferase Increased | 258 (1.15%) |
Nausea | 247 (1.1%) |
Ageusia | 246 (1.1%) |
Blood Creatine Phosphokinase Increa... | 242 (1.08%) |
Blood Alkaline Phosphatase Increase... | 236 (1.05%) |
Malaise | 231 (1.03%) |
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This graph shows the top adverse events submitted to the FDA for Terbinafine, 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 Terbinafine 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 Terbinafine adverse events reported to the FDA?
Epidermal And Dermal Conditions | 2516 (11.22%) |
Hepatobiliary | 1550 (6.91%) |
Neurological | 1091 (4.87%) |
Hepatic And Hepatobiliary | 1047 (4.67%) |
Hematology Investigations | 966 (4.31%) |
Gastrointestinal Signs | 735 (3.28%) |
Enzyme | 693 (3.09%) |
Infections - Pathogen Unspecified | 494 (2.2%) |
Muscle | 442 (1.97%) |
Respiratory | 410 (1.83%) |
Therapeutic And Nontherapeutic Effe... | 402 (1.79%) |
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This graph shows the top categories of adverse events submitted to the FDA for Terbinafine, 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 Terbinafine 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 Terbinafine, according to those reporting adverse events to the FDA?
Nail Tinea | 1425 |
Onychomycosis | 1409 |
Fungal Infection | 331 |
Tinea Pedis | 318 |
Tinea Infection | 114 |
Drug Use For Unknown Indication | 103 |
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Label | Labeler | Effective |
---|---|---|
Terbinafine Hydrochloride | Wockhardt USA, LLC | 25-NOV-09 |
Terbinafine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | 16-SEP-10 |
Terbinafine Hydrochloride | Glenmark Generics Inc., USA | 27-JAN-11 |
Terbinafine Hydrochloride | Rebel Distributors Corp | 09-FEB-11 |
Terbinafine Hydrochloride | Preferred Pharmaceuticals, Inc | 02-AUG-11 |
Terbinafine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | 11-AUG-11 |
Terbinafine Hydrochloride | Bryant Ranch Prepack | 12-AUG-11 |
Terbinafine Hydrochloride | Taro Pharmaceuticals U.S.A., Inc. | 30-AUG-11 |
Terbinex | Innocutis | 20-OCT-11 |
Terbinafine Hydrochloride | AvKARE, Inc. | 20-OCT-11 |
Terbinafine Hydrochloride | Mylan Pharmaceuticals Inc. | 14-NOV-11 |
Terbinafine Hydrochloride | Cardinal Health | 28-DEC-11 |
Terbinafine Hydrochloride | Golden State Medical Supply, Inc. | 09-JAN-12 |
Terbinafine Hydrochloride | Breckenridge Pharmaceutical, Inc. | 26-MAR-12 |
Terbinafine Hydrochloride | Preferred Pharmaceuticals, Inc | 05-APR-12 |
Terbinafine | Exelan Pharmaceuticals Inc. | 18-APR-12 |
Lamisil | Novartis Pharmaceuticals Corporation | 30-APR-12 |
Lamisil | Novartis Pharmaceuticals Corporation | 30-APR-12 |
Terbinafine Hydochloride | Physicians Total Care, Inc. | 07-MAY-12 |
Terbinafine Hydrochloride | Physicians Total Care, Inc. | 06-JUL-12 |
Terbinafine Hydochloride | Apotex Corp | 01-AUG-12 |
Terbinafine Hydrochloride | Northstar Rx LLC | 10-AUG-12 |
Terbinafine Hydrochloride | Dr.Reddys Laboratories Limited | 24-AUG-12 |
Terbinafine Hydrochloride | Wockhardt USA LLC. | 03-SEP-12 |
Terbinafine Hydrochloride | Wockhardt Limited | 07-SEP-12 |
Terbinafine Hydrochloride | Camber Pharmaceuticals | 18-SEP-12 |
Terbinafine Hydrochloride | Walgreen Company | 12-DEC-12 |
Terbinafine | Aurobindo Pharma Limited | 15-DEC-12 |
Terbinafine Hydrochloride | Harris Pharmaceutical, Inc. | 01-FEB-13 |
Terbinafine Hydrochloride | REMEDYREPACK INC. | 11-FEB-13 |
Kaiser Permanente Terbinafine Hydrochloride | Kaiser Foundation Hospitals | 19-MAR-13 |
Terbinafine Hydrochloride | Teva Pharmaceuticals USA Inc | 08-APR-13 |
What Terbinafine safety concerns are being reported by doctors and researchers in the medical literature?
This report contains aggregated drug side effects and adverse events for Terbinafine. 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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