How are Labetalol adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Labetalol, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Labetalol is flagged as the suspect drug causing the adverse event.
What are the most common Labetalol adverse events reported to the FDA?
Drug Exposure During Pregnancy | 77 (3.17%) |
Hypotension | 65 (2.68%) |
Caesarean Section | 44 (1.81%) |
Premature Baby | 42 (1.73%) |
Blood Pressure Increased | 40 (1.65%) |
Bradycardia | 34 (1.4%) |
Hypertension | 34 (1.4%) |
Nausea | 34 (1.4%) |
Cardiac Arrest | 31 (1.28%) |
Drug Ineffective | 30 (1.24%) |
Dyspnoea | 25 (1.03%) |
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This graph shows the top adverse events submitted to the FDA for Labetalol, 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 Labetalol 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 Labetalol adverse events reported to the FDA?
Cardiac Arrhythmias | 141 (5.81%) |
Cardiac And Vascular Investigations | 125 (5.15%) |
Chemical Injury And Poisoning | 112 (4.61%) |
Neurological | 112 (4.61%) |
Decreased And Nonspecific Blood Pre... | 95 (3.91%) |
Gastrointestinal Signs | 93 (3.83%) |
Respiratory | 89 (3.67%) |
Medication Errors | 82 (3.38%) |
Therapeutic And Nontherapeutic Effe... | 76 (3.13%) |
Vascular Hypertensive | 60 (2.47%) |
Neonatal And Perinatal Conditions | 57 (2.35%) |
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This graph shows the top categories of adverse events submitted to the FDA for Labetalol, 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 Labetalol 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 Labetalol, according to those reporting adverse events to the FDA?
Hypertension | 761 |
Product Used For Unknown Indication | 259 |
Drug Use For Unknown Indication | 223 |
Blood Pressure | 79 |
Blood Pressure Increased | 28 |
Pre-eclampsia | 22 |
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Label | Labeler | Effective |
---|---|---|
Trandate | Prometheus Laboratories Inc. | 14-DEC-09 |
Labetalol Hydrochloride | Bedford Laboratories | 25-APR-10 |
Labetalol Hcl | UDL Laboratories, Inc. | 19-NOV-10 |
Labetalol Hydrochloride | REMEDYREPACK INC. | 30-NOV-10 |
Labetalol Hydrochloride | Rebel Distributors Corp | 28-DEC-10 |
Labetalol Hydrochloride | REMEDYREPACK INC. | 20-JUN-11 |
Labetalol Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | 29-AUG-11 |
Labetalol Hydrochloride | STAT RX USA LLC | 01-SEP-11 |
Labetalol Hydrochloride | Rebel Distributors Corp | 21-SEP-11 |
Labetalol Hydrochloride | REMEDYREPACK INC. | 27-SEP-11 |
Labetalol Hcl | Eon Labs, Inc. | 29-SEP-11 |
Labetalol Hydrochloride | Watson Laboratories, Inc. | 18-OCT-11 |
Labetalol Hydrochloride | Akorn, Inc. | 13-DEC-11 |
Labetalol Hydrochloride | Hospira, Inc. | 17-FEB-12 |
Labetalol Hydrochloride | Hospira, Inc. | 17-FEB-12 |
Labetalol Hydrochloride | Mylan Institutional LLC | 01-MAR-12 |
Labetalol Hydrochloride | Dispensing Solutions, Inc. | 07-MAR-12 |
Labetalol Hydrochloride | American Health Packaging | 12-MAR-12 |
Labetalol Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | 29-MAR-12 |
Labetalol Hydrochloride | Physicians Total Care, Inc. | 02-APR-12 |
Labetalol Hydrochloride | Gland Pharma Limited | 19-APR-12 |
Labetalol Hcl | Cardinal Health | 24-APR-12 |
Labetalol Hydrochloride | McKesson Contract Packaging | 10-MAY-12 |
Labetalol Hcl | Par Pharmaceutical Companies, Inc. | 25-JUL-12 |
Labetalol Hydrochloride | IVAX Pharmaceuticals, Inc. | 01-AUG-12 |
Labetalol Hydrochloride | Major Pharmaceuticals | 30-AUG-12 |
Labetalol Hcl | McKesson Packaging Services a business unit of McKesson Corporation | 31-AUG-12 |
Labetalol | Sagent Pharmaceuticals | 27-SEP-12 |
Labetalol Hcl | Cantrell Drug Company | 18-NOV-12 |
Labetalol Hcl | Cantrell Drug Company | 30-NOV-12 |
Labetalol Hydrochloride | Cardinal Health | 22-MAR-13 |
What Labetalol safety concerns are being reported by doctors and researchers in the medical literature?
This report contains aggregated drug side effects and adverse events for Labetalol. 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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