Rosuvastatin

Rosuvastatin is evaluated for the following indications with varying evidence strength: Established ASCVD, secondary prevention (evidence tier A), Dyslipidemia, primary CV prevention (evidence tier A), Familial hypercholesterolemia (evidence tier A). See the full indication matrix with dosing and citations above on this page.

Common side effects of Rosuvastatin (≥ 1 in 100): Myalgia without CK elevation, Headache, Dyspepsia, nausea, Arthralgia, Transient transaminase elevation. See the Safety section for uncommon and serious reactions.

FDA category X. In July 2021 the FDA removed the automatic contraindication during pregnancy from labels of all statins (Drug Safety Communication, 2021-07-20). The FDA pregnancy categories (A/B/C/D/X) were retired in 2015 under the PLLR — historically rosuvastatin was classified as X. The decision is now individualized: in patients without atherosclerotic CVD, statins are usually discontinued before conception and throughout pregnancy; in those with documented atherosclerosis and high event risk, continuation is possible after shared decision-making with a cardiologist. An unplanned pregnancy is a trigger for discussion, not for default discontinuation.

Systemic safety data during lactation are limited. The manufacturer and most international sources recommend avoidance. In patients with a statin indication, options include a temporary switch to formula feeding or deferring therapy until breastfeeding is complete.

Rosuvastatin is contraindicated in: Active liver disease or unexplained persistent transaminase elevation; Severe renal impairment (CrCl below 30 mL/min) for the 40 mg dose; Hypersensitivity to rosuvastatin or any component. Full list in the Safety section.