Rosuvastatin

Crestor reduces major cardiovascular events—cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or arterial revascularization—in adults at increased risk.

With diet and exercise, lowers LDL-C in adults with hypercholesterolemia and slows adult atherosclerosis progression. HeFH treatment is labeled from age 8, and HoFH treatment from age 7. Adult hypertriglyceridemia and primary dysbetalipoproteinemia are additional diet-adjunct indications.

This profile summarizes Crestor tablets. Other brands, generic labels, combination medicines, and alternative dosage forms may have different labeled uses or instructions. It does not provide an exhaustive off-label treatment guide.

Take tablets once daily at any time, with or without food; swallow whole. Do not take an extra dose after a missed dose. Take Crestor at least 2 hours before an aluminum / magnesium hydroxide antacid.

Assess LDL-C as clinically appropriate, as early as 4 weeks after starting, and adjust to response. Interaction-related limits may be lower than the usual maximum.

Mild to moderate renal impairment has no recommended adjustment. The 5 mg start and 10 mg maximum for severe impairment apply to patients not receiving hemodialysis; they are not a dialysis dosing rule. Renal disease increases muscle-injury risk. Acute liver failure and decompensated cirrhosis are contraindications; alcohol-associated liver disease increases exposure.

Ezallor Sprinkle is a separate capsule product with product-specific instructions for swallowing, opening, and tube administration. Do not crush Crestor tablets or apply capsule instructions to tablets.

Acute liver failure, decompensated cirrhosis, or hypersensitivity to rosuvastatin or product ingredients. Pregnancy is no longer listed as an absolute contraindication; see population-specific guidance.

The selected Crestor tablet label has no boxed warning. Its warnings and precautions still require attention to muscle injury, hepatic injury, and relevant population and interaction risks.

Common trial reports included headache, nausea, muscle pain, weakness, and constipation.

Serious reactions include muscle injury, hepatic injury, and hypersensitivity. Trial frequencies depend on study design and are not comparative risk estimates across statins.

Fibrates, lipid-modifying niacin (≥1 g / day), and colchicine add muscle risk; weigh benefit and monitor if combined. Obtain INR before starting in warfarin users and check frequently after starting, dose changes, or discontinuation until stable. Separate aluminum / magnesium hydroxide antacids by giving Crestor at least 2 hours before them.

These are the selected label’s interaction instructions, not a complete screen for every newly prescribed medicine. Check both drug labels before adding treatment.

Stop treatment when pregnancy is recognized in most patients; the label permits consideration of ongoing therapeutic needs. FDA removed the class-wide pregnancy contraindication in 2021 to allow individualized decisions, particularly for very high-risk patients. Notify the prescriber promptly about a known or suspected pregnancy. Observational data have not established an increase in major birth defects; this does not establish safety for every pregnancy.

Breastfeeding is not recommended during treatment. Discuss temporary treatment interruption versus continued statin therapy with alternative infant feeding based on the patient’s cardiovascular needs.

Crestor HeFH use is established from age 8 and HoFH from age 7. Younger ages and other pediatric hypercholesterolemias are not established uses.

Choose doses cautiously in older adults and monitor for muscle symptoms. Organ impairment and polypharmacy increase risk; see dosing for the relevant renal and hepatic distinctions.

Inhibits HMG-CoA reductase, reducing cholesterol synthesis and increasing hepatic LDL-receptor-mediated clearance. LDL-C response guides dosing; plasma concentration alone is not the treatment target.

Absorption

Peak concentration approximately 3–5 hours; bioavailability about 20%.

Metabolism

Limited metabolism, principally CYP2C9; parent drug accounts for most inhibitory activity.

Transport / interactions

OATP1B1 and BCRP substrate; clearance is not substantially dependent on CYP3A4.

Elimination / half-life

About 90% of an oral dose excreted in feces; half-life approximately 19 hours.

• Reassess LDL-C as early as 4 weeks after starting and adjust to the individualized plan.
• Consider liver enzymes before treatment and thereafter when clinically indicated. Evaluate jaundice, dark urine, appetite loss, fatigue, or right-upper-abdominal discomfort.
• Investigate unexplained muscle symptoms; CK and renal assessment are appropriate when muscle injury is suspected. Persistent weakness after stopping warrants assessment for immune-mediated myopathy.
• Review glucose risk and reinforce healthy diet, activity, and weight management.
• Warfarin users need INR checks around initiation, dose changes, and stopping. Consider dose reduction for unexplained persistent proteinuria or hematuria on routine testing.

• Use the prescribed once-daily schedule and avoid doubling missed doses.
• Maintain diet and activity measures alongside drug treatment. Review all new medicines and supplements with the prescriber or pharmacist.
• Promptly report unexplained muscle symptoms, especially with fever or feeling unwell. Seek urgent care for a severe allergic reaction.
• Discuss pregnancy or breastfeeding promptly with the treating clinician.
• For overdose, contact U.S. Poison Control at 1-800-222-1222; emergency symptoms require emergency care.

Other strengths and manufacturers have different appearances and package identifiers. Verify the exact imprint and original packaging with a pharmacist.

Dosage form / strengths

Coated oral tablets · 5, 10, 20, 40 mg

Label distributor

AstraZeneca Pharmaceuticals LP

Representative appearance

5 mg: yellow, round, biconvex tablet

Imprint

ZD4522 and 5 on one side

Example package NDC

0310-7560-90 · 90 tablets

Selected tablets

5, 10, 20, 40 mg

Additional formulation

Ezallor Sprinkle capsules · 5, 10, 20, 40 mg; separate label and administration instructions apply.

Other products

Generic and combination products require their own labeling.

Crestor: store at 20–25°C (68–77°F), with permitted excursions 15–30°C (59–86°F); protect from moisture.

Follow the exact formulation’s storage instructions and retain packaging to identify the medicine.