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.

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

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)

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

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 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.

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 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.

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 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.

moderate rosuvastatin

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.

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 causes rosuvastatin levels to rise significantly, which increases the danger of severe muscle damage.

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

Common Questions

Can I take Roszet with food?
Yes, you can take Roszet with or without food.
What should I do if I have muscle pain?
Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness.
Can I drink alcohol while taking Roszet?
Talk to your doctor about drinking alcohol while taking Roszet.
How long will I need to take Roszet?
You may need to take Roszet long-term to manage your cholesterol.
Will I need blood tests while taking Roszet?
Yes, your doctor will likely do blood tests to check your cholesterol and liver function.
Can I stop taking Roszet if my cholesterol is better?
Do not stop taking Roszet without talking to your doctor first.
What if I am Asian?
Your doctor may start you on a lower dose of 5 mg daily.
Can I take antacids with Roszet?
Take Roszet at least 2 hours before taking an antacid.
What happens if I have kidney problems?
Your doctor may start you on a lower dose of 5 mg daily and not exceed 10mg daily.
What are the different strengths of Roszet?
Roszet comes in 5 mg, 10 mg, 20 mg, and 40 mg tablets.
What are the common side effects of rosuvastatin/ezetimibe?
The registry lists Headache, Nausea, Muscle pain, Weakness, Constipation among the most-reported FAERS reaction terms for rosuvastatin/ezetimibe. The compiled record contains 87,323 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does rosuvastatin/ezetimibe interact with other medications?
The registry has 12 documented interaction rows for rosuvastatin/ezetimibe. Notable source-record pairings include sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, febuxostat. These rows are not a complete medication review.
What drug class is rosuvastatin/ezetimibe?
rosuvastatin/ezetimibe belongs to the Statin / Cholesterol Absorption Inhibitor drug class. It requires a prescription (Rx). This medicine can help lower LDL cholesterol (bad cholesterol) if you have high cholesterol.
What pregnancy or breastfeeding source fields are listed for rosuvastatin/ezetimibe?
The FDA label for rosuvastatin/ezetimibe contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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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 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).

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