Prescription medication · Statin / Cholesterol Absorption Inhibitor
rosuvastatin/ezetimibe
Also sold as Roszet. This medicine can help lower LDL cholesterol (bad cholesterol) if you have high cholesterol.
Data updated 2026-05-15
- 87,323
- FDA reports
- 12
- InteractionsSeveral interactions
- Rx
- Availability
What the data shows
rosuvastatin/ezetimibe (Roszet) is a prescription Statin / Cholesterol Absorption Inhibitor, with 87,323 FDA adverse-event reports on file, with 12 documented drug interactions.
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/ezetimibe (Roszet) is a prescription Statin / Cholesterol Absorption Inhibitor. This medicine can help lower LDL cholesterol (bad cholesterol) if you have high cholesterol.
Roszet contains rosuvastatin, which is a statin medicine. It helps lower bad cholesterol and reduce the risk of heart problems.
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What it does
This medicine can help lower LDL cholesterol (bad cholesterol) if you have high cholesterol.
Common side effects
Headache, Nausea, Muscle pain
Key warnings
Rosuvastatin can sometimes cause muscle problems, including rhabdomyolysis.
The sections below are summarized in plain English from rosuvastatin/ezetimibe's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Rosuvastatin blocks a substance your body needs to make cholesterol. This lowers the amount of cholesterol in your blood. It helps prevent heart attacks and strokes.
How to Take It
Take Roszet once a day, with or without food. You can take it at any time of day. Try to take it at the same time each day. Your doctor may change your dose based on your cholesterol levels.
This is a plain-language summary of rosuvastatin/ezetimibe's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Rosuvastatin can harm your unborn baby. Do not take this medicine if you are pregnant. Breastfeeding is also not recommended while taking rosuvastatin.
This is a plain-language summary of rosuvastatin/ezetimibe'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, just take your next dose at the regular time. Do not take an extra dose to make up for the missed one.
This is a plain-language summary of rosuvastatin/ezetimibe's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Roszet at room temperature, away from moisture.
Side Effects (from patient reports)
Based on 87,323 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for rosuvastatin/ezetimibe, 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.
Serious Warnings
Rosuvastatin can sometimes cause muscle problems, including rhabdomyolysis. This can damage your kidneys. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel sick. This medicine can also cause liver problems. Your doctor may do blood tests to check your liver.
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 antiviral medicine increases the amount of rosuvastatin in your system by changing how your body processes it. Higher levels of the drug can increase the risk of muscle damage.
What to do: You should start with a low 5 mg dose of rosuvastatin and never take more than 10 mg daily while using this combination.
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 hepatitis C drugs block the pathways your body uses to remove rosuvastatin, leading to higher levels of the statin in your blood. This can increase your risk for serious side effects.
What to do: Your doctor should start your rosuvastatin at 5 mg daily and keep the dose at or below 10 mg per day.
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 interferes with the way your body handles rosuvastatin, which can nearly double the amount of the drug in your bloodstream. This buildup increases the chance of experiencing harmful side effects.
What to do: When taking these two drugs together, ensure your rosuvastatin dose does not exceed 20 mg once daily.
7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of rosuvastatin with other drugs that increase the risk of myopathy and rhabdomyolysis. ( 7.1 ) Aluminum and Magnesium Hydroxide Combination Antacids : Administer rosuvastatin at least 2 hours before the antacid. ( 7.2 ) Warfarin : Obtain INR prior to starting rosuvastatin.
Mechanism: Antacids can stop your body from properly absorbing rosuvastatin if they are taken too close together.
What to do: Make sure to take your rosuvastatin at least two hours before you take any antacids.
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 causes rosuvastatin levels to rise significantly, which increases the danger of severe muscle damage.
What to do: This combination increases the risk of muscle breakdown, so your doctor may need to adjust your treatment or avoid using them together.
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 Roszet with food?
What should I do if I have muscle pain?
Can I drink alcohol while taking Roszet?
How long will I need to take Roszet?
Will I need blood tests while taking Roszet?
Can I stop taking Roszet if my cholesterol is better?
What if I am Asian?
Can I take antacids with Roszet?
What happens if I have kidney problems?
What are the different strengths of Roszet?
What are the common side effects of rosuvastatin/ezetimibe?
Does rosuvastatin/ezetimibe interact with other medications?
What drug class is rosuvastatin/ezetimibe?
Is rosuvastatin/ezetimibe safe during pregnancy?
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What the FDA Data Shows for rosuvastatin/ezetimibe
The FDA label for rosuvastatin/ezetimibe (sold under brand names such as Roszet) classifies it as a prescription-only medication in the Statin / Cholesterol Absorption Inhibitor class. This medicine can help lower LDL cholesterol (bad cholesterol) if you have high cholesterol. 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 87,323 voluntary reports. The database also lists 12 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
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, 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).
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