Harvoni (ledipasvir/sofosbuvir) tablet Olysio (simeprevir) capsule Sovaldi (sofosbuvir) tablet Cardiac arrhythmia, bradycardia “Warning and Precautions,” “Adverse Reactions,” and “Drug Interactions” sections of the labeling and the […]

Codeine is an opioid pain reliever used to treat mild to moderately severe pain. It is also used, usually in combination with other medications, to reduce coughing.  […]

1. What is codeine and how is it used? Codeine is a type of pain medicine called an opioid. Codeine is used to treat mild to […]

Acetaminophen Pediatric ingestion errors Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen_Final Guidance (8/4/15) Bloxiverz (neostigmine methylsulfate) injection Vazculep (phenylephrine HCl) injection Potential product selection errors […]

[ 11-15-2017 ] The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk […]

[09-21-2017] The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate […]

Docket Number: FDA-2025-D-6131 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the […]

[ 5-22-2017 ] A U.S. Food and Drug Administration (FDA) review to date has not identified adverse health effects from gadolinium retained in the brain after […]

DPP-4 inhibitors are a class of prescription medicines that are used with diet and exercise to control high blood sugar in adults with type 2 diabetes. […]