How are Valacyclovir adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Valacyclovir, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Valacyclovir is flagged as the suspect drug causing the adverse event.
What are the most common Valacyclovir adverse events reported to the FDA?
Drug Ineffective | 971 (3.3%) |
Renal Failure Acute | 822 (2.8%) |
Dizziness | 641 (2.18%) |
Nausea | 622 (2.12%) |
Dysarthria | 521 (1.77%) |
Blood Creatinine Increased | 506 (1.72%) |
Altered State Of Consciousness | 500 (1.7%) |
Depressed Level Of Consciousness | 493 (1.68%) |
Vomiting | 480 (1.63%) |
Encephalopathy | 415 (1.41%) |
Headache | 406 (1.38%) |
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This graph shows the top adverse events submitted to the FDA for Valacyclovir, 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 Valacyclovir 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 Valacyclovir adverse events reported to the FDA?
Neurological | 4139 (14.08%) |
Gastrointestinal Signs | 1577 (5.36%) |
Renal Disorders | 1573 (5.35%) |
Epidermal And Dermal Conditions | 1383 (4.7%) |
Therapeutic And Nontherapeutic Effe... | 1310 (4.46%) |
Renal And Urinary Tract Investigati... | 1123 (3.82%) |
Deliria | 782 (2.66%) |
Viral Infectious | 733 (2.49%) |
Disturbances In Thinking | 597 (2.03%) |
Encephalopathies | 505 (1.72%) |
Medication Errors | 485 (1.65%) |
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This graph shows the top categories of adverse events submitted to the FDA for Valacyclovir, 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 Valacyclovir 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 Valacyclovir, according to those reporting adverse events to the FDA?
Herpes Zoster | 3248 |
Drug Use For Unknown Indication | 1049 |
Genital Herpes | 802 |
Herpes Virus Infection | 488 |
Product Used For Unknown Indication | 486 |
Prophylaxis | 414 |
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Label | Labeler | Effective |
---|---|---|
Valacyclovir Hydrochloride | Bryant Ranch Prepack | 24-MAY-10 |
Valacyclovir Hydrochloride | Roxane Laboratories, Inc | 24-MAY-10 |
Valacyclovir Hydrochloride | Dr. Reddys Laboratories Limited | 22-SEP-10 |
Valacyclovir Hydrochloride | Actavis Inc. | 22-NOV-10 |
Valacyclovir Hydrochloride | MedVantx, Inc. | 13-DEC-10 |
Valacyclovir Hydrochloride | Rebel Distributors Corp | 13-APR-11 |
Valtrex | Cardinal Health | 02-MAY-11 |
Valacyclovir Hydrochloride | PD-Rx Pharmaceuticals, Inc. | 15-JUL-11 |
Valacyclovir Hydrochloride | Rebel Distributors Corp | 09-AUG-11 |
Valacyclovir Hydrochloride | Mylan Pharmaceuticals Inc. | 09-DEC-11 |
Valtrex | PD-Rx Pharmaceuticals, Inc. | 16-DEC-11 |
Valacyclovir Hydrochloride | Physicians Total Care, Inc. | 03-JAN-12 |
Valacyclovir Hydrochloride | Mylan Institutional Inc. | 10-FEB-12 |
Valacyclovir Hydrochloride | McKesson Packaging Services a business unit of McKesson Corporation | 21-FEB-12 |
Valtrex | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 20-MAR-12 |
Valacyclovir Hydrochloride | Life Line Home Care Services, Inc. | 22-MAR-12 |
Valacyclovir Hydrochloride | American Health Packaging | 27-MAR-12 |
Valacyclovir Hydrochloride | Ranbaxy Pharmaceuticals Inc. | 11-APR-12 |
Valacyclovir Hydrochloride | H.J. Harkins Company, Inc. | 18-APR-12 |
Valacyclovir Hydrochloride | Jubilant Cadista Pharmaceuticals Inc. | 31-MAY-12 |
Valacyclovir Hydrochloride | Aurobindo Pharma Limited | 12-JUN-12 |
Valacyclovir Hydrochloride | Teva Pharmaceuticals USA Inc | 25-JUL-12 |
Valacyclovir Hydrochloride | Greenstone LLC | 04-SEP-12 |
Valtrex | Physicians Total Care, Inc. | 04-SEP-12 |
Valacyclovir Hydrochloride | NorthStar Rx LLC | 14-SEP-12 |
Valacyclovir Hydrochloride | American Health Packaging | 29-NOV-12 |
Valacyclovir Hydrochloride | Watson Laboratories, Inc. | 29-NOV-12 |
Valtrex | Bryant Ranch Prepack | 21-JAN-13 |
Valtrex | Bryant Ranch Prepack | 21-JAN-13 |
Valacyclovir Hydrochloride | Sandoz Inc | 18-FEB-13 |
Valtrex | GlaxoSmithKline LLC | 01-APR-13 |
Valacyclovir Hydrochloride | Wockhardt Limited | 03-APR-13 |
Valacyclovir Hydrochloride | Wockhardt USA LLC. | 03-APR-13 |
Valacyclovir Hydrochloride | REMEDYREPACK INC. | 09-APR-13 |
Valacyclovir Hydrochloride | Cardinal Health | 22-APR-13 |
What Valacyclovir safety concerns are being reported by doctors and researchers in the medical literature?
This report contains aggregated drug side effects and adverse events for Valacyclovir. 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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