Prescription medication · HMG-CoA Reductase Inhibitor (Statin)

rosuvastatin

Also sold as Crestor. Rosuvastatin is used to lower bad cholesterol (LDL) in adults and children.

Data updated 2026-05-15

194,743
FDA reportsHeavily reported
21
InteractionsSeveral interactions
99% less
Generic vs brandHuge savings
2
Recall records

What the data shows

rosuvastatin (Crestor) is a prescription HMG-CoA Reductase Inhibitor (Statin), more reported than roughly 9 in 10 tracked drugs (194,743 FDA reports), whose generic costs a fraction of the brand (about 99% less).

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

rosuvastatin (Crestor) is a prescription HMG-CoA Reductase Inhibitor (Statin). Rosuvastatin is used to lower bad cholesterol (LDL) in adults and children.

Rosuvastatin is a drug that lowers cholesterol. It helps to reduce the risk of heart problems and stroke.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Brand Price

$8.86/unit

Generic Price

$0.04/unit

Generic Savings

99%

Generic Available

Yes (18 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

NADAC price trail: ROSUVASTATIN CALCIUM 10 MG TAB

Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -3.9% vs prior release.

Effective NADAC / unit vs prior NDCs
April 17, 2024 $0.0412/EA - 1
December 18, 2024 $0.0396/EA -3.9% 42
View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

Rosuvastatin is used to lower bad cholesterol (LDL) in adults and children.

Common side effects

Headache, Nausea, Muscle pain

Key warnings

Rosuvastatin can cause muscle problems, including muscle pain, tenderness, or weakness.

The sections below are summarized in plain English from rosuvastatin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Rosuvastatin belongs to a class of drugs called statins. It works by blocking a substance your body needs to make cholesterol. This helps to lower your cholesterol levels.

Side Effects (from patient reports)

Based on 194,743 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for rosuvastatin, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for rosuvastatin each year to the FDA Adverse Event Reporting System (FAERS).

05,00010,00015,00020,000 20042007201020132016201920222025 15,358

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where rosuvastatin sits

rosuvastatin has more FDA adverse-event reports than 94% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is rosuvastatin; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 194,743 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

194,743

Reports Mentioning Death

11,716

6.0% of reports — not proof of cause

Hospitalization Reports

60,611

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 95,342 (53%)
Male 85,358 (47%)

Age Distribution

0–17 612
18–44 5,735
45–64 49,058
65–74 42,871
75+ 33,545

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 FATIGUE 11,700
2 NAUSEA 10,039
4 DYSPNOEA 9,208
5 DIARRHOEA 9,198
6 MYALGIA 8,784
8 PAIN 8,417
9 HEADACHE 7,796
10 DIZZINESS 7,718
11 ARTHRALGIA 7,255
12 ASTHENIA 7,203
13 PAIN IN EXTREMITY 6,768
14 MALAISE 6,483
15 FALL 6,006
16 VOMITING 5,828
17 ACUTE KIDNEY INJURY 5,250

Reactions in Death Reports

DEATH 4,212
PNEUMONIA 619
DYSPNOEA 592
ACUTE KIDNEY INJURY 583
RENAL FAILURE 518
CARDIAC ARREST 510
MYOCARDIAL INFARCTION 474
ASTHENIA 400
SEPSIS 388
NAUSEA 387

Reactions in Hospitalization Reports

DYSPNOEA 4,090
ACUTE KIDNEY INJURY 3,518
FALL 3,443
NAUSEA 3,384
DIARRHOEA 3,216
FATIGUE 3,191
PNEUMONIA 3,131
ASTHENIA 3,079
VOMITING 2,653
PAIN 2,459

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Rosuvastatin can cause muscle problems, including muscle pain, tenderness, or weakness. Tell your doctor right away if you have these symptoms, especially if you also have a fever or feel sick. Rosuvastatin can also cause liver problems. Your doctor may do blood tests to check your liver before and during treatment.

Known Drug Interactions

major sofosbuvir/velpatasvir

Intervention: Sofosbuvir/velpatasvir/voxilaprevir Ledipasvir/sofosbuvir Avoid concomitant use with rosuvastatin. Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir Initiate with rosuvastatin 5 mg once daily, and do not exceed a dose of rosuvastatin 10 mg once daily.

Mechanism: This hepatitis C medication can increase the amount of rosuvastatin that stays in your blood.

major glecaprevir/pibrentasvir

Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir Initiate with rosuvastatin 5 mg once daily, and do not exceed a dose of rosuvastatin 10 mg once daily.

Mechanism: These drugs can cause rosuvastatin levels to rise in your body, which may increase the risk of side effects.

major febuxostat

Febuxostat Clinical Impact: Febuxostat increased rosuvastatin exposure more than 1.9-fold. Intervention: In patients taking febuxostat, do not exceed a dose of rosuvastatin 20 mg once daily.

Mechanism: Febuxostat slows down how your body gets rid of rosuvastatin, causing the medicine to build up in your blood. This increase can make side effects more likely.

moderate cyclosporine

Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Cyclosporine Clinical Impact: Cyclosporine increased rosuvastatin exposure 7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with rosuvastatin.

Mechanism: Cyclosporine stops your body from clearing rosuvastatin, leading to much higher levels of the drug in your blood. This increase makes it much more likely that you will experience severe muscle damage.

moderate ledipasvir/sofosbuvir

Intervention: Sofosbuvir/velpatasvir/voxilaprevir Ledipasvir/sofosbuvir Avoid concomitant use with rosuvastatin.

Mechanism: These medications can raise the levels of rosuvastatin in your blood to unsafe levels. This increases your risk of developing serious muscle problems.

Check all your medications →

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I take rosuvastatin with other medications?
Talk to your doctor about all the medicines you take, including over-the-counter drugs, vitamins, and herbal products. Some medicines can interact with rosuvastatin.
How long will I need to take rosuvastatin?
You will likely need to take rosuvastatin for a long time to manage your cholesterol levels.
Can I drink alcohol while taking rosuvastatin?
Talk to your doctor about drinking alcohol while taking rosuvastatin. Alcohol can increase your risk of liver problems.
What should I do if I experience muscle pain while taking rosuvastatin?
Tell your doctor right away if you experience unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick.
Will I need blood tests while taking rosuvastatin?
Yes, your doctor will likely do blood tests to check your cholesterol levels and liver function.
Can I stop taking rosuvastatin if my cholesterol levels are good?
Do not stop taking rosuvastatin without talking to your doctor first. Your cholesterol levels may increase if you stop taking it.
Does rosuvastatin have any effect on diabetes?
Rosuvastatin may slightly increase blood sugar levels. If you have diabetes, your doctor may monitor your blood sugar more closely.
Are there any foods I should avoid while taking rosuvastatin?
You should follow a healthy diet low in saturated fat and cholesterol while taking rosuvastatin.
Can rosuvastatin cause weight gain?
Weight gain is not a common side effect of rosuvastatin.
Is it safe for elderly people to take rosuvastatin?
Older adults may be more likely to experience muscle problems while taking rosuvastatin. Your doctor may start you on a lower dose.
What are the common side effects of rosuvastatin?
The registry lists Headache, Nausea, Muscle pain, Weakness, Constipation among the most-reported FAERS reaction terms for rosuvastatin. The compiled record contains 194,743 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does rosuvastatin interact with other medications?
The registry has 21 documented interaction rows for rosuvastatin. Notable source-record pairings include sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, febuxostat. These rows are not a complete medication review.
What drug class is rosuvastatin?
rosuvastatin belongs to the HMG-CoA Reductase Inhibitor (Statin) drug class. It requires a prescription (Rx). Rosuvastatin is used to lower bad cholesterol (LDL) in adults and children.
Is there a generic version of rosuvastatin?
Yes, generic rosuvastatin is available from 18 manufacturers. The generic costs $0.04 per unit compared to $8.86 for the brand version, saving approximately 99%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
What pregnancy or breastfeeding source fields are listed for rosuvastatin?
The FDA label for rosuvastatin contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has rosuvastatin been recalled?
There are 2 recalls associated with rosuvastatin products. Out of specification for dissolution. Check the recalls section below for full details and affected products.

Active Recalls

Class II December 31, 2025

Out of specification for dissolution.

AvKARE

Class II March 23, 2023

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc.

Related Medications in HMG-CoA Reductase Inhibitor (Statin)

Other drugs grouped near rosuvastatin - same-class peers and common alternatives.

alirocumab

Praluent

Praluent is a medicine that can lower cholesterol.

Compare with rosuvastatin →

atorvastatin

Lipitor

Atorvastatin is a drug that lowers cholesterol and reduces the risk of heart problems and stroke.

Compare with rosuvastatin →

bempedoic acid

Nexletol

Compare with rosuvastatin →

bempedoic acid/ezetimibe

Nexlizet

Nexlizet is a combination medicine that helps lower cholesterol.

Compare with rosuvastatin →

cholestyramine

Questran

Cholestyramine is a medicine that helps lower high cholesterol levels in your blood.

Compare with rosuvastatin →

Compare rosuvastatin vs alirocumab side-by-side →

Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for rosuvastatin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

Similar FAERS report volume

Nearest drugs by total FAERS reports. This record: 194,743.

4 peers

Similar death-report share

Nearest drugs by FAERS death-report share. This record: 6.02%.

4 peers

Medication Guides

Understanding Drug Interactions

How CYP450 enzymes, inhibitors, and inducers affect your medications

Generic vs Brand Name Drugs

FDA requirements, cost savings, and when the difference matters

Narrow Therapeutic Index Drugs

FDA bioequivalence and label-record context for narrow therapeutic index medicines

Common Drug Interactions

Dangerous medication combinations and how to protect yourself

Save on rosuvastatin

Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.

Check Prices on GoodRx →

Disclosure: This link may earn us a commission at no extra cost to you. See our terms.

What the FDA Data Shows for rosuvastatin

The FDA label for rosuvastatin (sold under brand names such as Crestor) classifies it as a prescription-only medication in the HMG-CoA Reductase Inhibitor (Statin) class. Rosuvastatin is used to lower bad cholesterol (LDL) in adults and children. Official labeling lists 5 commonly reported side effects, including Headache, Nausea, Muscle pain.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 194,743 voluntary reports. The database also lists 21 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.04 versus $8.86 for the brand - a 99% generic savings.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: November 26, 2025

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page