PHARMACOVIGILANCE PROFILING OF DRUG SIDE EFFECTS, THERAPEUTIC CLASSES, AND MEDICAL CONDITIONS
Abstract
Pharmacovigilance profiling is important for understanding how drug safety information is distributed across medicines, therapeutic classes, and medical conditions. This study aimed to profile drug side effects, therapeutic classes, prescription status, pregnancy category, controlled-substance classification, and patient-reported rating patterns using a secondary drug-information dataset. A retrospective data-based design was adopted. The study included 2,931 drug records covering 2,912 unique drug names and 47 medical conditions. Data were analyzed using frequency distribution, percentage analysis, cross-tabulation, and summary statistics. The highest representation was observed for pain, colds and flu, acne, and hypertension. Prescription-only medicines formed the largest category, accounting for 68.17% of records. Pregnancy category C was the most frequent classification, while most medicines were non-controlled substances. Therapeutic class analysis showed major representation of upper respiratory combinations, topical acne agents, topical steroids, antihistamines, nonsteroidal anti-inflammatory drugs, laxatives, opioid analgesics, CNS stimulants, insulin, antiviral combinations, and antirheumatics. Side-effect information was most frequently associated with dermatological, allergic,
respiratory, neurological, and gastrointestinal categories. Rating and review activity was highest for acne, anxiety, weight loss, diabetes type 2, ADHD, depression, bipolar disorder, pain, insomnia, and hypertension. The findings indicate that secondary drug-information records can support pharmacovigilance-oriented profiling of safety information, therapeutic classes, and medical-condition patterns, although results should be interpreted as information patterns rather than confirmed adverse-event incidence.
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