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 →
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.
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.
This is a plain-language summary of rosuvastatin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of rosuvastatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of rosuvastatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store rosuvastatin at room temperature, away from moisture.
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
- Tiredness
Tiredness
11,698 reports
- Feeling sick to your stomach
Feeling sick to your stomach
10,037 reports
- Difficulty breathing
Difficulty breathing
9,212 reports
- Loose stools
Loose stools
9,199 reports
- Muscle pain
Muscle pain
8,784 reports
- General pain
General pain
8,419 reports
- Head pain
Head pain
7,798 reports
- Feeling lightheaded
Feeling lightheaded
7,718 reports
- Joint pain
Joint pain
7,254 reports
- Weakness
Weakness
7,204 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.
Reports over time
Adverse-event reports filed for rosuvastatin each year to the FDA Adverse Event Reporting System (FAERS).
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.
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
Age Distribution
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
Reactions in Hospitalization Reports
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take rosuvastatin with other medications?
How long will I need to take rosuvastatin?
Can I drink alcohol while taking rosuvastatin?
What should I do if I experience muscle pain while taking rosuvastatin?
Will I need blood tests while taking rosuvastatin?
Can I stop taking rosuvastatin if my cholesterol levels are good?
Does rosuvastatin have any effect on diabetes?
Are there any foods I should avoid while taking rosuvastatin?
Can rosuvastatin cause weight gain?
Is it safe for elderly people to take rosuvastatin?
What are the common side effects of rosuvastatin?
Does rosuvastatin interact with other medications?
What drug class is rosuvastatin?
Is there a generic version of rosuvastatin?
Is rosuvastatin safe during pregnancy?
Has rosuvastatin been recalled?
Active Recalls
Out of specification for dissolution.
AvKARE
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Preferred Pharmaceuticals, Inc.
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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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 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
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages