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Simvastatin / sitagliptin Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 23, 2023.

Applies to simvastatin / sitagliptin: oral tablet.

Warning

You should not use this medicine if you have liver disease or severe kidney disease. Do not use if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Do not use simvastatin and sitagliptin if you are pregnant, and stop taking the medicine if you become pregnant.

Do not use simvastatin and sitagliptin if you are breast-feeding.

There are many other drugs that should not be used together with simvastatin and sitagliptin. Tell your doctor about all other medicines you use. Do not consume grapefruit products while taking simvastatin and sitagliptin.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, simvastatin and sitagliptin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Stop using simvastatin and sitagliptin and call your doctor at once if you have:

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to simvastatin / sitagliptin: oral tablet.

Cardiovascular

Simvastatin:

Very common (10% or more): Atrial fibrillation[Ref]

Dermatologic

Simvastatin:

Very common (10% or more): Eczema

Uncommon (0.1% to 1%): Rash

Simvastatin-sitagliptin:

Postmarketing reports: Pruritus, alopecia, variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails)[Ref]

Endocrine

Simvastatin:

Very common (10% or more): Diabetes mellitus[Ref]

Genitourinary

Simvastatin:

Very common (10% or more): Urinary tract infection

Simvastatin-sitagliptin:

Postmarketing reports: Erectile dysfunction, gynecomastia[Ref]

Hematologic

Simvastatin:

Very common (10% or more):Elevation of creatinine kinase (CK)

Frequency not reported: Elevated alkaline phosphatase and gamma-glutamyl transpeptidase

Simvastatin-sitagliptin:

Postmarketing reports: Anemia

Elevation of CK levels of 3 or more times the normal value has been reported. This was attributable to the noncardiac fraction of CK.

Musculoskeletal

Sitagliptin: Between October 2006 and December 2013, thirty-three cases of severe arthralgia have been reported to the FDA Adverse Event Reporting System Database. Each case involved the use of 1 or more dipeptidyl peptidase-4 (DPP-4) inhibitor. In all cases, substantial reduction in prior activity level was reported, 10 patients were hospitalized due to disabling joint pain. In 22 cases, symptoms appeared within 1 month of starting therapy, in 23 cases symptoms resolved less than 1 month after discontinuation. A positive rechallenge was reported in 8 cases, with 6 cases involving use of a different DPP-4 inhibitor. Sitagliptin had the greatest number of cases reported (n=28) followed by saxagliptin (n=5), linagliptin (n=2), alogliptin (n=1), and vildagliptin (n=2).[Ref]

Simvastatin:

Very common (10% or more): Myalgia

Uncommon (0.1% to 1%): Asthenia

Rare (less than 0.1%): Myopathy, rhabdomyolysis

Postmarketing reports: Immune-mediated necrotizing myopathy

Simvastatin-sitagliptin:

Postmarketing reports: muscle cramps, myalgia, rhabdomyolysis, arthralgia, pain in extremity, back pain[Ref]

Gastrointestinal

Simvastatin:

Common (1% to 10%): Abdominal pain, constipation, nausea, flatulence, gastritis

Uncommon (0.1% to 1%): Acid regurgitation, diarrhea, dyspepsia

Sitagliptin

Common (1% to 10%): Abdominal pain, constipation, nausea, flatulence

Uncommon (0.1% to 1%): Acid regurgitation, diarrhea, dyspepsia, pancreatitis

Simvastatin-sitagliptin:

Postmarketing reports: Pancreatitis, acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis, constipation, vomiting

General

Simvastatin:

Common (1% to 10%): Edema, swelling[Ref]

Metabolic

Sitagliptin:

Common (1% to 10%): Hypoglycemia

Nervous system

Simvastatin:

Common (1% to 10%): Headache, insomnia, vertigo

Sitagliptin:

Common (1% to 10%): Headache

Simvastatin-sitagliptin:

Postmarketing reports: Peripheral neuropathy, dizziness, paresthesia[Ref]

Respiratory

Simvastatin:

Common (1% to 10%): Upper respiratory infection, bronchitis, sinusitis

Sitagliptin:

Common (1% to 10%): Upper respiratory tract infections, nasopharyngitis

Simvastatin-sitagliptin:

Postmarketing reports: Interstitial lung disease[Ref]

Hepatic

Simvastatin

Uncommon (0.1% to 1%): Elevated transaminases

Simvastatin-sitagliptin:

Postmarketing reports: Hepatitis/jaundice, fatal and non-fatal hepatic failure, hepatic enzymes elevation

Hypersensitivity

Simvastatin:

Postmarketing reports: Anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatic, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticarial, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme (including Stevens-Johnson syndrome).

Sitagliptin:

Postmarketing reports: Anaphylaxis, angioedema, rash, urticarial, cutaneous vasculitis, exfoliative skin conditions including Stevens-Johnson syndrome[Ref]

Renal

Simvastatin-sitagliptin:

Postmarketing reports: Worsening of renal function, including acute renal failure (sometimes requiring dialysis)[Ref]

Psychiatric

Simvastatin:

Postmarketing reports: Cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion)

Simvastatin-sitagliptin:

Postmarketing reports: Depression

Cognitive impairment is reversible up on statin discontinuation.

References

1. Product Information. Juvisync (simvastatin-sitagliptin). Merck & Co., Inc. 2011.

2. US Food and Drug Administration. FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf 2015.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.