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5 Interactions found for:

Zetia and Crestor
Interactions Summary
  • 4 Major
  • 1 Moderate
  • 0 Minor
  • Zetia
  • Crestor

Drug Interactions

Moderate
Zetia + Crestor

The following applies to the ingredients: Ezetimibe (found in Zetia) and Rosuvastatin (found in Crestor)

MONITOR: Coadministration with ezetimibe may rarely increase the risk of myopathy and serum transaminase elevations associated with HMG-CoA reductase inhibitors (i.e., statins). The mechanism of interaction is unknown. A case report describes two patients whose serum creatine kinase increased after ezetimibe was added to their statin therapy (atorvastatin and fluvastatin, respectively). One of the patients also developed myalgia and tendinopathy, which resolved promptly after withdrawal of both drugs. Statin therapy was subsequently reintroduced at the previous dosage without incident. In the other patient, serum creatine kinase returned to normal within 4 weeks after discontinuation of ezetimibe while the statin was continued. On the contrary, no cases of myopathy or tendinopathy occurred in a study of 33 hypercholesterolemic patients treated with ezetimibe and atorvastatin or simvastatin. There were also no reports of myopathy or significant increases in serum creatine kinase in a study of 32 subjects treated with ezetimibe and fluvastatin. In controlled clinical studies, the incidence of consecutive elevations (greater than 3 times the upper limit of normal) in serum transaminases was 1.3% for patients treated with ezetimibe in combination with a statin versus 0.4% for patients treated with a statin alone. These elevations were generally asymptomatic, not associated with cholestasis, and returned to baseline after discontinuation of therapy or with continued treatment.

MANAGEMENT: Until further information is available, use of a statin in combination with ezetimibe should be approached with caution. Some authorities consider concomitant use to be contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases. Patients should be advised to promptly report to their physician any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. The drugs should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed. In addition, liver function tests should be performed at initiation of therapy and according to the recommendations of the HMG-CoA reductase inhibitor.

References

  1. Gagne C, Gaudet D, Bruckert E "Efficacy and safety of ezetimibe coadministered with atorvastatin or simvastatin in patients with homozygous familial hypercholesterolemia." Circulation 105 (2002): 2469-75
  2. Fux R, Morike K, Gundel UF, Hartmann R, Gleiter CH "Ezetimibe and statin-associated myopathy." Ann Intern Med 140 (2004): 671-2
  3. "Product Information. Ezetimibe (ezetimibe)." Camber Pharmaceuticals, Inc (2024):
  4. "Product Information. Ag-Ezetimibe (ezetimibe)." Angita Pharma Inc. (2023):
  5. "Product Information. Ezetimibe (Apo) (ezetimibe)." Apotex Pty Ltd (2024):
  6. "Product Information. Ezetimibe (ezetimibe)." Sandoz Ltd (2024):

Drug and Food Interactions

No food interactions were found for selected drugs: Zetia, Crestor.

This does not necessarily mean no interactions exist. Always consult your healthcare provider.

Drug and Pregnancy Interactions

The following applies to the ingredients: Ezetimibe (found in Zetia)

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk summary: There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-According to some authorities: Concomitant therapy with a statin is contraindicated during pregnancy.
-Refer to the manufacturer product information for any statin, fenofibrate, or other LDL-C lowering therapy used in combination with this drug for additional recommendations on use during pregnancy.

Animal studies have failed to reveal evidence of direct or indirect harmful effects on pregnancy, embryofetal development, or on birth/postnatal development. Administration of this drug to pregnant animals during the period of organogenesis at doses ranging from 10 to 150 times the human exposure at the maximum recommended human dose (MRHD) resulted in an increased incidence of common fetal skeletal findings (e.g., extra thoracic ribs). Placental drug transfer was demonstrated in animal studies.

Administration of this drug in combination with a statin during animal studies resulted in higher exposures to this drug and/or the statin as compared to monotherapy; fetal abnormalities were observed. There were no adverse fetal effects observed when this drug was given concomitantly with fenofibrate at doses corresponding to 5 times (total ezetimibe) and 38 times (fenofibric acid) the anticipated MRHD. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

References

  1. "Product Information. Ezetimibe (ezetimibe)." Camber Pharmaceuticals, Inc (2024):
  2. "Product Information. Ezetimibe (Apo) (ezetimibe)." Apotex Pty Ltd (2024):
  3. "Product Information. Ezetimibe (ezetimibe)." Sandoz Ltd (2024):

The following applies to the ingredients: Rosuvastatin (found in Crestor)

Contraindicated

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Safety in pregnant women has not been established and there is no apparent benefit to use during pregnancy. Because HMG-CoA reductase inhibitors (statins) decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, this drug may cause fetal harm during pregnancy.

Comments:
-This drug should be discontinued as soon as pregnancy is recognized, and the patient should be apprised of the potential harm to the fetus.
-Women of childbearing potential should use adequate methods of contraception during therapy.

Animal studies have failed to reveal evidence of teratogenicity in doses approximating the maximum human dose of 40 mg/day. Limited published data has not shown an increased risk of major congenital malformations or miscarriage, although there have been rare reports of congenital anomalies following intrauterine exposure to other statins. Several cases of serious fetal abnormalities were reported in 2 series of 178 and 143 cases among pregnant women taking a HMG-CoA reductase inhibitor (statin) during the first trimester of pregnancy. These included limb and neurological defects, spontaneous abortions and fetal deaths. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. There are no controlled data in human pregnancy.

Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on long term outcomes of primary hyperlipidemia therapy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

References

  1. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf" (2007):
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Drug and Breastfeeding Interactions

The following applies to the ingredients: Ezetimibe (found in Zetia)

Use is considered acceptable; benefit to mother should outweigh risk to the infant.
-According to some authorities: Use is not recommended during lactation.

Excreted into human milk: Yes (in very low amounts)

Comments:
-If this drug is used in combination with a statin, treatment should be avoided (or may be contraindicated) in patients who are breastfeeding; consult the manufacturer product information.
-There are no data on the effects of this drug on the breastfed infant or on milk production.
-Case reports and pharmacokinetic models predict that serum levels in infants exposed to this drug during breastfeeding are considerably lower than in adults.

References

  1. "Product Information. Ezetimibe (ezetimibe)." Camber Pharmaceuticals, Inc (2024):
  2. "Product Information. Ezetimibe (Apo) (ezetimibe)." Apotex Pty Ltd (2024):
  3. "Product Information. Ezetimibe (ezetimibe)." Sandoz Ltd (2024):
  4. Bethesda (MD): National Institute of Child Health and Human Development (US) "Ezetimibe - Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK501635/" (2024):

The following applies to the ingredients: Rosuvastatin (found in Crestor)

Contraindicated

Excreted into human milk: Yes (in low amounts)

Comments:
-Due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism, women who require treatment with this drug should not breastfeed.

References

  1. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc (2003):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):

Therapeutic Duplication Warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

Switch to: Consumer Interactions

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

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