Simvastatin / Sitagliptin Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 15, 2024.

Applies to simvastatin / sitagliptin: oral tablet.

Important warnings This medicine can cause some serious health issues

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:

• confusion, memory problems;

• swelling, weight gain, urinating less than usual or not at all;

• severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate;

• increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

• itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• headache; or

• nausea, stomach pain.

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.

General adverse events

Simvastatin:

• Common (1% to 10%): Edema, swelling^[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

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]

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]

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

Cardiovascular

Simvastatin:

• Very common (10% or more): Atrial fibrillation^[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

• Uncommon (0.1% to 1%): Elevated transaminases

Simvastatin-sitagliptin:

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

Simvastatin

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.

Further information

Simvastatin/sitagliptin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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