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Adverse event. In pharmaceuticals, an adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended symptom or sign ...
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. [1]: 1.1 Adverse Drug Reaction (ADR) [2] ADRs may occur following a single dose or prolonged administration of a drug or may result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side ...
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. The FDA uses FAERS to monitor for new adverse events and medication errors that might ...
Vaccine adverse event. Vaccine adverse event. Other names. Vaccine injury. Specialty. Emergency medicine. A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event believed to have been caused by vaccination. [1] The World Health Organization (WHO) refers to Adverse Events Following Immunization (AEFI).
Pharmacology. An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. [ 1 ] An adverse effect may be termed a " side effect ", when judged to be secondary to a main or therapeutic effect. The term complication is similar to adverse effect, but the latter is typically used in ...
Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [ 4 ] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [ 3 ][ 5 ] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [ 2 ] Reintroduced 2002 with restricted indication ...
Serious adverse event. In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose. Results in death. Is life-threatening. Requires inpatient hospitalization or causes prolongation of existing hospitalization. Results in persistent or significant disability/incapacity.
The Common Terminology Criteria for Adverse Events (CTCAE), [1] formerly called the Common Toxicity Criteria (CTC or NCI-CTC), are a set of criteria for the standardized classification of adverse events of drugs and treatment used in cancer therapy. The CTCAE system is a product of the US National Cancer Institute (NCI).