1Research Scholar, Department of Pharmacology, TMMC&RC, Teerthanker Mahaveer University, Moradabad (U.P), India
Email: 619yashg@gmail.com
2Professor, Department of Pharmacology, TMMC&RC, Teerthanker Mahaveer University, Moradabad (U.P), India
Corresponding Author: Yash Goel, Research Scholar, Department of Pharmacology, TMMC&RC, Teerthanker Mahaveer University, Moradabad (U.P), India
Email: 619yashg@gmail.com
Statins are the cornerstone of lipid-lowering therapy for the prevention of cardiovascular diseases. Among them, atorvastatin and rosuvastatin are widely prescribed high-intensity statins due to their potent efficacy in reducing low-density lipoprotein cholesterol (LDL-C) and cardiovascular morbidity and mortality. Despite their overall favorable safety profile, statins are associated with adverse drug reactions (ADRs) affecting musculoskeletal, hepatic, metabolic, neurological, and gastrointestinal systems. Pre-marketing clinical trials may not adequately detect rare, delayed, or population-specific adverse effects, highlighting the importance of post-marketing pharmacovigilance.
This review evaluates and compares the safety profiles of atorvastatin and rosuvastatin with particular emphasis on pharmacovigilance signal detection. A narrative review of literature published between 2000 and 2025 was conducted using electronic databases including PubMed, Scopus, Web of Science, Embase, and Google Scholar. Pharmacovigilance databases such as the FDA Adverse Event Reporting System (FAERS) and WHO Vigibase were also examined. Studies including pharmacovigilance analyses, randomized controlled trials, observational studies, and systematic reviews assessing statin safety were included. Signal detection methods such as reporting odds ratio (ROR) and proportional reporting ratio (PRR) were reviewed to identify disproportionate reporting of adverse drug reactions.
Available evidence indicates that both statins have favorable benefit–risk profiles; however, pharmacokinetic differences influence their safety patterns. Atorvastatin, a lipophilic statin extensively metabolized by CYP3A4, shows stronger signal associations with hepatotoxicity, diabetes mellitus, and neurological adverse effects. Rosuvastatin, a hydrophilic statin with greater hepatoselectivity and minimal cytochrome P450 metabolism, demonstrates relatively lower systemic adverse effects. Pharmacovigilance signal detection plays a crucial role in identifying rare adverse drug reactions, improving drug safety monitoring, and supporting individualized statin therapy.
Keywords: Atorvastatin, Rosuvastatin, Pharmacovigilance, Signal Detection, Adverse Drug Reactions, Drug Safety, Reporting Odds Ratio.
How to cite this article: Goel Y, Matreja PS. Safety Profile of Atorvastatin and Rosuvastatin: Significance of Pharmacovigilance Signal Detection. Int J Drug Deliv Technol. 2026;16(6s): 954-959; DOI: 10.25258/ijddt.16.6s.124
Source of support: None
Conflict of interest: None