Note: This document contains side effect information about simvastatin / sitagliptin. Some dosage forms listed on this page may not apply to the brand name Juvisync.
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.
