Rosuvastatin

Generic name: rosuvastatin calcium · Brand names: Crestor, Ezallor Sprinkle (no longer on the market per MedlinePlus), Roszet (rosuvastatin + ezetimibe; no longer on the market per MedlinePlus)

Quick facts

Drug class
Rosuvastatin is a statin (HMG-CoA reductase inhibitor).
Section
Highlights, Indications and Usage
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: (1)
Rx or otc
Rx (prescription label with FDA-approved patient labeling) - source: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Controlled schedule
Not controlled (no schedule appears in the label text read)
Forms and strengths
  • Tablets: 5 mg, 10 mg, 20 mg, and 40 mg of rosuvastatin. (3)
  • Torrent: 5 mg yellow round film coated tablets debossed '79'; 10 mg light pink round debossed '1180'; 20 mg light pink round debossed '1181'; 40 mg light pink oval debossed '1182'. (3)
Generic available
Value
yes - this page is based on the generic label from Torrent Pharmaceuticals Limited (tablet, coated)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Common use one line
Lowers cholesterol and reduces the risk of heart attack and stroke in adults at increased risk (label Indications).

What it is used for

Rosuvastatin lowers LDL cholesterol with diet and exercise, helps slow atherosclerosis, lowers the risk of heart attack, stroke and related events in adults at increased risk, and treats familial hypercholesterolemia in adults and in children aged 8 years and older (HeFH) or 7 years and older (HoFH). It also treats hypertriglyceridemia and primary dysbetalipoproteinemia in adults. It is the generic of Crestor.
Section
1 INDICATIONS AND USAGE
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Rosuvastatin tablets are indicated: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): o in adults with hypercholesterolemia. o and slow the progression of atherosclerosis in adults. o in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). o in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.

How it works

Rosuvastatin blocks an enzyme the body needs to make cholesterol.
Section
12.1 Mechanism of Action
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.

Dosage: adults

The adult dose range is 5 to 40 mg once a day, at any time of day, with or without food. Swallow tablets whole. LDL-C can be checked as early as 4 weeks after starting.
Section
2.2 Recommended Dosage in Adult Patients; 2.1 General Dosage and Administration Information (sentences joined from both)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
The dosage range for rosuvastatin tablets are 5 to 40 mg orally once daily. • The recommended dosage of rosuvastatin tablets depends on a patient’s indication for usage, LDL-C, and individual risk for CV events. [2.1] Administer rosuvastatin tablets orally as a single dose at any time of day, with or without food. Swallow the tablets whole. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust the dosage if necessary.

Dosage: children

Children with HeFH: 5 mg to 10 mg once daily for ages 8 to less than 10 years, and 5 mg to 20 mg once daily for ages 10 years and older. Children 7 years and older with HoFH: 20 mg once daily.
Section
2.3 Recommended Dosage in Pediatric Patients
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Dosage in Pediatric Patients 8 Years of Age and Older with HeFH The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older. Dosage in Pediatric Patients 7 Years of Age and Older with HoFH The recommended dosage is 20 mg orally once daily.

Dosage adjustments

Drug interaction caps
Several drugs require a lower rosuvastatin cap (5 mg, 10 mg or 20 mg once daily) or should be avoided. See the interaction list.
Section
2.6 Table 1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir: Avoid concomitant use. Gemfibrozil: Avoid concomitant use. If use is unavoidable, initiate at 5 mg once daily and do not exceed 10 mg once daily. Tafamidis: Avoid concomitant use. If use is unavoidable, initiate at 5 mg once daily and do not exceed 20 mg once daily. Belumosudil, Cyclosporine, Darolutamide, Vadadustat: Do not exceed 5 mg once daily. Additional Antiviral Medications (Simeprevir; Dasabuvir/ombitasvir/paritaprevir/ritonavir; Elbasvir/Grazoprevir; Sofosbuvir/Velpatasvir; Glecaprevir/Pibrentasvir; Atazanavir/Ritonavir; Lopinavir/Ritonavir): Initiate at 5 mg once daily. Do not exceed 10 mg once daily. Capmatinib, Enasidenib, Momelotinib, Regorafenib, Teriflunomide: Do not exceed 10 mg once daily. Ticagrelor: Do not exceed 20 mg once daily. In patients at increased risk for rhabdomyolysis, consider dosages less than 20 mg per day. Febuxostat, Fostamatinib: Do not exceed 20 mg once daily. (Table 1 rows regrouped by identical instruction; wording unchanged.)
Kidney
With severe kidney impairment (not on dialysis) start at 5 mg once daily and do not go above 10 mg once daily. No adjustment is recommended for mild or moderate impairment.
Section
2.5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
In patients with severe renal impairment (CLcr less than 30 mL/min/1.73 m2) not on hemodialysis, the recommended starting dosage is 5 mg orally once daily and should not exceed 10 mg orally once daily [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)]. There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.
Liver
Do not use with acute liver failure or decompensated cirrhosis. Heavy alcohol use or past liver disease may raise the risk of liver injury.
Section
8.7 Hepatic Impairment
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Rosuvastatin tablets are contraindicated in patients with acute liver failure or decompensated cirrhosis. Chronic alcohol liver disease is known to increase rosuvastatin exposure. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury
Elderly
Age 65 or older raises the risk of muscle problems, so dose choice should be cautious.
Section
8.5 Geriatric Use
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Advanced age (≥65 years) is a risk factor for rosuvastatin tablets-associated myopathy and rhabdomyolysis. Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy.
Asian patients
Asian patients start at 5 mg once daily because blood levels are higher.
Section
2.4
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Initiate rosuvastatin tablets at 5 mg orally once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of rosuvastatin tablets when treating Asian patients not adequately controlled at dosages up to 20 mg orally once daily

Missed dose

If you miss a dose, do not take an extra dose. Take the next dose as usual.
Section
2.1 General Dosage and Administration Information
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose.

Overdose

Label
There is no known antidote. For an overdose call Poison Help at 1-800-222-1222.
Section
10 OVERDOSAGE
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
No specific antidotes for rosuvastatin tablets are known. Hemodialysis does not significantly enhance clearance of rosuvastatin. In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
Medlineplus
Call poison control at 1-800-222-1222, or 911 if the person has collapsed, had a seizure, has trouble breathing or cannot be awakened.
Source
https://medlineplus.gov/druginfo/meds/a603033.html
Source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Storage

Store at 20°C to 25°C (68°F to 77°F). Short trips to 15°C to 30°C (59°F to 86°F) are permitted. Protect from moisture. Torrent label detail; other labelers may differ.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING (Storage)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Boxed warning

NONE (no boxed warning appears in the label text read)

Contraindications

Do not use with acute liver failure or decompensated cirrhosis.
Section
4 CONTRAINDICATIONS
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)].
Do not use if allergic to rosuvastatin or its other ingredients. Rash, itching, hives and angioedema have been reported.
Section
4 CONTRAINDICATIONS
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets.

Warnings and precautions

Rosuvastatin can cause muscle damage (myopathy) and a severe form called rhabdomyolysis, which can harm the kidneys. Risk is higher at age 65 or older, with uncontrolled low thyroid, kidney problems, certain drugs, and the 40 mg dose. Report unexplained muscle pain, tenderness or weakness, especially with fever or feeling unwell.
Heading
5.1 Myopathy and Rhabdomyolysis
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Rosuvastatin tablets may cause myopathy [muscle pain, tenderness, or weakness associated with elevated creatine kinase (CK)] and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including rosuvastatin tablets. Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher rosuvastatin tablets dosage. Asian patients on rosuvastatin tablets may be at higher risk for myopathy. The myopathy risk is greater in patients taking rosuvastatin tablets 40 mg daily compared with lower rosuvastatin tablets dosages. Discontinue rosuvastatin tablets if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Rare autoimmune muscle disease has been reported with statins. Stop rosuvastatin if it is suspected.
Heading
5.2 Immune-Mediated Necrotizing Myopathy
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered. Discontinue rosuvastatin tablets if IMNM is suspected.
Liver enzymes can rise (above three times the upper limit in 1.1% on rosuvastatin vs 0.5% on placebo). Liver tests may be done before and during treatment. Stop it if serious liver injury or jaundice occurs.
Heading
5.3 Hepatic Dysfunction
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Increases in serum transaminases have been reported with use of rosuvastatin tablets [see Adverse Reactions (6.1)]. In a pooled analysis of placebo-controlled trials, increases in serum transaminases to more than three times the ULN occurred in 1.1% of patients taking rosuvastatin tablets versus 0.5% of patients treated with placebo. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin tablets. Consider liver enzyme testing before rosuvastatin tablets initiation and when clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue rosuvastatin tablets.
Protein or blood in the urine was seen, more often at 40 mg. A lower dose may be considered if it persists without explanation.
Heading
5.4 Proteinuria and Hematuria
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Although the clinical significance of this finding is unknown, consider a dose reduction for patients on rosuvastatin tablets therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing.
Blood sugar and HbA1c can rise, sometimes above the level used to diagnose diabetes.
Heading
5.5 Increases in HbA1c and Fasting Serum Glucose Levels
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Increases in HbA1c and fasting serum glucose levels have been reported with statins, including rosuvastatin tablets. Based on clinical trial data with rosuvastatin tablets, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus [see Adverse Reactions (6.1)].

Pregnancy and breastfeeding

Pregnancy
Stop rosuvastatin when pregnancy is recognized, or weigh the ongoing need with your doctor. It may cause fetal harm.
Section
8.1 Pregnancy
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Discontinue rosuvastatin tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin tablets decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin tablets may cause fetal harm when administered to pregnant patients based on the mechanism of action
Lactation
Breastfeeding is not recommended during treatment.
Section
8.2 Lactation
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with rosuvastatin tablets.

Side effects

Common
The most frequent side effects (rate 2% or more) are headache, nausea, muscle pain, weakness (asthenia) and constipation.
Threshold
rate ≥2%
Section
Highlights, Adverse Reactions (6.1)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Most frequent adverse reactions (rate ≥2%) are headache, nausea, myalgia, asthenia, and constipation. (6.1)
Less common
Longer studies at 40 mg (METEOR) and 20 mg (JUPITER) also showed joint pain, dizziness, abdominal pain, diabetes mellitus reports and lab changes. Other reactions seen in studies include pancreatitis and hypersensitivity.
Section
6.1 Tables 2, 3, 4 and text
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Table 2 (placebo-controlled, up to 12 weeks; Placebo N=382 vs Total rosuvastatin 5 mg to 40 mg N=744, %): Headache 5.0 vs 5.5; Nausea 3.1 vs 3.4; Myalgia 1.3 vs 2.8; Asthenia 2.6 vs 2.7; Constipation 2.4 vs 2.4. Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. METEOR (40 mg, n=700 vs placebo n=281, %): Myalgia 12.7 vs 12.1; Arthralgia 10.1 vs 7.1; Headache 6.4 vs 5.3; Dizziness 4.0 vs 2.8; Increased CPK 2.6 vs 0.7; Abdominal pain 2.4 vs 1.8; ALT greater than 3x ULN 2.2 vs 0.7. JUPITER (20 mg n=8,901 vs placebo n=8,901, %): Myalgia 7.6 vs 6.6; Arthralgia 3.8 vs 3.2; Constipation 3.3 vs 3.0; Diabetes mellitus 2.8 vs 2.3; Nausea 2.4 vs 2.3. (Table values transcribed; all label tables in 6.1 use the >=2% threshold, so no sub-threshold table exists in this label.)
Serious
Label
Serious items include muscle breakdown, liver problems, high blood sugar, and rare reports of low platelets, nerve problems, memory problems, depression, lung disease and severe skin reactions.
Section
6 ADVERSE REACTIONS; 6.2 Postmarketing Experience
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Myopathy and Rhabdomyolysis; Immune-Mediated Necrotizing Myopathy; Hepatic Dysfunction; Proteinuria and Hematuria; Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.1 to 5.5)]. Postmarketing: Blood Disorders: thrombocytopenia. Hepatobiliary Disorders: hepatitis, jaundice, fatal and non-fatal hepatic failure. Musculoskeletal Disorders: arthralgia, rare reports of immune-mediated necrotizing myopathy associated with statin use. Nervous System Disorders: peripheral neuropathy, rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with the use of all statins. Psychiatric Disorders: depression, sleep disorders (including insomnia and nightmares). Reproductive System and Breast Disorders: gynecomastia. Respiratory Disorders: interstitial lung disease. Skin and Subcutaneous Tissue Disorders: drug reaction with eosinophilia and systemic symptoms (DRESS), lichenoid drug eruption
Medlineplus
MedlinePlus says to call your doctor right away or get emergency help for these symptoms.
Section
What side effects can this medication cause?
Source
https://medlineplus.gov/druginfo/meds/a603033.html
Source text (exact source wording)
muscle pain, tenderness, or weakness (or if these symptoms continue after stopping rosuvastatin); lack of energy; fever; dark, reddish urine or decreased amount of urine; yellowing of the skin or eyes; pain in the upper right part of the abdomen; nausea; unusual bleeding or bruising; loss of appetite; flu-like symptoms; rash, hives, itching, difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; hoarseness
Led to discontinuation
Section
n/a
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display

Interactions

Drugs
Avoid using together. Raises muscle-damage risk.
Name
Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir
Section
7.1 Table 5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Avoid concomitant use with rosuvastatin tablets. Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis.
Avoid. If unavoidable, start at 5 mg once daily and do not exceed 10 mg once daily.
Name
Gemfibrozil
Section
7.1 Table 5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Avoid concomitant use of gemfibrozil with rosuvastatin tablets. If use is unavoidable, initiate rosuvastatin tablets at 5 mg once daily and do not exceed a dosage of rosuvastatin tablets 10 mg once daily.
Avoid. If unavoidable, start at 5 mg once daily and do not exceed 20 mg once daily.
Name
Tafamidis
Section
7.1 Table 5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Avoid concomitant use of tafamidis with rosuvastatin tablets. If use is unavoidable, initiate rosuvastatin tablets at 5 mg once daily and do not exceed a dosage of rosuvastatin tablets 20 mg once daily.
Do not exceed 5 mg once daily. Cyclosporine raised exposure 7-fold.
Name
Cyclosporine
Section
7.1 Table 5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
In patients taking cyclosporine, do not exceed a dosage of rosuvastatin tablets 5 mg once daily. Cyclosporine increased rosuvastatin exposure 7-fold.
Do not exceed 5 mg once daily.
Name
Belumosudil, darolutamide, vadadustat
Section
7.1 Table 5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
In patients taking belumosudil, do not exceed a dosage of rosuvastatin tablets 5 mg once daily. In patients taking darolutamide, do not exceed a dosage of rosuvastatin tablets 5 mg once daily. In patients taking vadadustat, do not exceed a dosage of rosuvastatin tablets 5 mg once daily.
Start at 5 mg once daily and do not exceed 10 mg once daily.
Name
Antiviral combinations (simeprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, atazanavir/ritonavir, lopinavir/ritonavir)
Section
7.1 Table 5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Initiate with rosuvastatin tablets 5 mg once daily, and do not exceed a dosage of rosuvastatin tablets 10 mg once daily.
Do not exceed 10 mg once daily.
Name
Capmatinib, enasidenib, momelotinib, regorafenib, teriflunomide
Section
7.1 Table 5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
In patients taking capmatinib, do not exceed a dosage of rosuvastatin tablets 10 mg once daily. In patients taking enasidenib, do not exceed a dosage of rosuvastatin tablets 10 mg once daily. In patients taking momelotinib, do not exceed a dosage of rosuvastatin tablets 10 mg once daily. In patients taking regorafenib, do not exceed a dosage of rosuvastatin tablets 10 mg once daily. In patients taking teriflunomide, do not exceed a dosage of rosuvastatin tablets 10 mg once daily.
Do not exceed 20 mg once daily; consider lower in higher-risk patients.
Name
Ticagrelor
Section
7.1 Table 5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
In patients taking ticagrelor, do not exceed a dosage of rosuvastatin tablets 20 mg once daily. In patients at increased risk for rhabdomyolysis [see Warnings and Precautions (5.1)], consider dosages less than 20 mg per day.
Do not exceed 20 mg once daily.
Name
Febuxostat, fostamatinib
Section
7.1 Table 5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
In patients taking febuxostat, do not exceed a dosage of rosuvastatin tablets 20 mg once daily. In patients taking fostamatinib, do not exceed a dosage of rosuvastatin tablets 20 mg once daily.
Weigh benefit against muscle risk and monitor for muscle symptoms.
Name
Fenofibrates, colchicine, niacin (lipid-modifying dosages ≥1 g/day)
Section
7.1 Table 5
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Consider if the benefit of using fibrates concomitantly with rosuvastatin tablets outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of either drug. (Same instruction appears for colchicine and for niacin lipid-modifying dosages (≥1 g/day).)
Take rosuvastatin at least 2 hours before the antacid. Antacid lowered exposure by 50%.
Name
Aluminum and magnesium hydroxide antacids
Section
7.2 Table 6
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
In patients taking an antacid, administer rosuvastatin tablets at least 2 hours before the antacid. Concomitant aluminum and magnesium hydroxide combination antacid administration decreased the mean exposure of rosuvastatin 50%
INR should be checked before starting and often after changes.
Name
Warfarin
Section
7.3 Table 7
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
In patients taking warfarin, obtain an INR before starting rosuvastatin tablets and frequently enough after initiation, dosage titration or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regularly recommended intervals.
Food and alcohol
Can be taken with or without food.
Name
Food
Section
2.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Source text (exact source wording)
Administer rosuvastatin tablets orally as a single dose at any time of day, with or without food.
Ask your doctor about alcohol; it can raise the risk of serious side effects.
Name
Alcohol (MedlinePlus)
Section
What special precautions should I follow?
Source
https://medlineplus.gov/druginfo/meds/a603033.html
Source text (exact source wording)
ask your doctor about the safe use of alcoholic beverages while you are taking rosuvastatin. Alcohol can increase the risk of serious side effects.

Patient tips

Medlineplus
Take once a day, at around the same time, with or without food. Swallow whole. Keep taking it even if you feel well. Do not stop without asking your doctor. Take antacids at least 2 hours after. Do not breastfeed. Eat a low-fat, low-cholesterol diet.
Section
How should this medicine be used? / precautions / diet
Source
https://medlineplus.gov/druginfo/meds/a603033.html
Source text (exact source wording)
Take once a day with or without food. Take rosuvastatin at around the same time every day. ... Swallow the tablets whole; do not split, chew, or crush them. Continue to take rosuvastatin even if you feel well. Do not stop taking rosuvastatin without talking to your doctor. ... if you are taking aluminum and magnesium hydroxide antacids, take them at least 2 hours after rosuvastatin. ... You should not breastfeed while taking rosuvastatin. ... Eat a low-fat, low-cholesterol diet. (Ellipses join separate sentences of the same page.)

Alternatives

Class from label
HMG Co-A reductase inhibitor (statin) (label Highlights, Indications)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display

Frequently asked questions

Question
What is rosuvastatin used for?
Answer
It lowers LDL cholesterol with diet and exercise, helps slow atherosclerosis, and lowers the risk of heart attack and stroke in adults at increased risk. It also treats familial hypercholesterolemia and some high triglyceride conditions.
Source section
1 INDICATIONS AND USAGE
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Question
Should I take rosuvastatin with food?
Answer
You can take it at any time of day, with or without food, as a single dose. Swallow tablets whole.
Source section
2.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Question
What if I miss a dose?
Answer
Do not take an extra dose. Resume treatment with the next dose.
Source section
2.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Question
What are the most common side effects?
Answer
The most frequent side effects (rate 2% or more) are headache, nausea, muscle pain, weakness (asthenia) and constipation.
Source section
Highlights; 6.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Question
What muscle symptoms should I report?
Answer
Report any unexplained muscle pain, tenderness or weakness, especially with fever or feeling unwell. These can be signs of myopathy or rhabdomyolysis.
Source section
5.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Question
Can I take antacids with rosuvastatin?
Answer
If you take an aluminum and magnesium hydroxide antacid, take rosuvastatin at least 2 hours before it.
Source section
7.2
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Question
Is rosuvastatin safe in pregnancy or while breastfeeding?
Answer
It may cause fetal harm and should be stopped when pregnancy is recognized, or the need weighed with your doctor. Breastfeeding is not recommended during treatment.
Source section
8.1, 8.2
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c2d481f-53f2-4cf6-bd28-7d92323785cd&type=display
Question
Should I stop when my cholesterol is good?
Answer
MedlinePlus says to continue taking it even if you feel well and not to stop without talking to your doctor.
Source section
How should this medicine be used?
Source
https://medlineplus.gov/druginfo/meds/a603033.html

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug