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Simvastatin / sitagliptin Side Effects

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 & Company Inc, Whitehouse Station, NJ.

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. Available from: URL: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf." ([2015, Aug 28]):

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.