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The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with ...
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). [1]
In 2012, the FDA rolled out the FDA Adverse Event Reporting System (FAERS), replacing the earlier AERS system. FAERS is an online database that is used by the FDA for safety surveillance of all approved drugs and therapeutic biologic products.
[127] [131] [132] Hundreds of additional cases of liver complications in people taking bicalutamide exist in the FDA Adverse Event Reporting System (FAERS) database. [133] In all of the published case reports of liver toxicity with bicalutamide, the onset of symptoms was within the first 6 months of treatment.
The US Food and Drug Administration (FDA) analyzed cases of pruritus after stopping cetirizine in the FDA Adverse Event Reporting System (FAERS) database and medical literature through April 2017. Their report noted that some patients indicated the itchiness impacted their ability to work, sleep or perform normal daily activities.
Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis; [3] [23] re-approved in June 2020 for the treatment of seizures associated with Dravet syndrome, under FDA orphan drug rules. Fenoterol: 1990 New Zealand Asthma mortality. [3] Feprazone: 1984 Germany, UK Cutaneous reaction, multiorgan toxicity. [3] Fipexide: 1991 France ...
Side effects of levosulpiride include amenorrhea, gynecomastia, galactorrhea, changes in libido, and neuroleptic malignant syndrome. [9] In the United States, as of 2013 only one case of adverse reaction to levosulpiride had been recorded on the FDA Adverse Event Reporting System Database. [8]