PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

rosuvastatin

Verify with FDA → · CMS NADAC pricing →

Brand names: Crestor

HMG-CoA Reductase Inhibitor (Statin) Rx

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

Drug Pricing (NADAC)

Brand Price

$8.86/unit

Generic Price

$0.04/unit

Generic Savings

100%

Generic Available

Yes (18 manufacturers)

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

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.

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.

How to Take It

Take rosuvastatin once a day, with or without food. You can take it at any time of day. Swallow the tablet whole with a drink of water. Your doctor may adjust your dose after 4 weeks, depending on your cholesterol levels.

Pregnancy & Breastfeeding

Do not take rosuvastatin if you are pregnant. It can harm your unborn baby. Talk to your doctor about other ways to control your cholesterol during pregnancy. Breastfeeding is not recommended while taking rosuvastatin.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.

Storage

Store rosuvastatin at room temperature, away from moisture.

Side Effects (from patient reports)

Based on 90,610 FDA adverse event reports.

Tiredness
11,698
Feeling sick to your stomach
10,037
The medicine is not working
9,223
Difficulty breathing
9,212
Loose stools
9,199
Muscle pain
8,784
Using the medicine for a different purpose than approved
8,522
General pain
8,419
Head pain
7,798
Feeling lightheaded
7,718

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

Death-Related Reports

11,716

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
3 DRUG INEFFECTIVE 9,223
4 DYSPNOEA 9,208
5 DIARRHOEA 9,198
6 MYALGIA 8,784
7 OFF LABEL USE 8,520
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

Reactions in Death Reports

DEATH 4,212
PNEUMONIA 619
DYSPNOEA 592
ACUTE KIDNEY INJURY 583
RENAL FAILURE 518
CARDIAC ARREST 510
MYOCARDIAL INFARCTION 474
OFF LABEL USE 438
ASTHENIA 400
SEPSIS 388

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
OFF LABEL USE 2,692
VOMITING 2,653

Source: FDA FAERS (Adverse Event Reporting System) 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

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.

What to do: If you take these together, start with a low 5 mg dose of rosuvastatin and do not take more than 10 mg per day.

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.

What to do: Your doctor should start you on a low 5 mg dose of rosuvastatin and keep the total daily dose at 10 mg or less.

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.

What to do: If you are taking both medications, your doctor should limit your rosuvastatin dose to a maximum of 20 mg per day.

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.

What to do: Avoid taking these two medicines together because the risk of muscle injury is greatly increased.

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.

What to do: You should avoid using these two medications at the same time.

Check all your medications →

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 most commonly reported side effects of rosuvastatin include Headache, Nausea, Muscle pain, Weakness, Constipation. Based on 90,610 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does rosuvastatin interact with other medications?
Yes, rosuvastatin has 21 known drug interactions. Notable interactions include sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, febuxostat. Always inform your doctor about all medications you are taking.
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 100%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is rosuvastatin safe during pregnancy?
Do not take rosuvastatin if you are pregnant. It can harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has rosuvastatin been recalled?
There is 1 recall associated with rosuvastatin products. cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Check the recalls section below for full details and affected products.

Active Recalls

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.

Compare rosuvastatin vs alirocumab side-by-side →

Medication Guides

Related Health & Safety Data

Save on rosuvastatin

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

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 90,610 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 100% 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 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: November 26, 2025

All federal data sources used on this page