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Juvisync Side Effects

Generic Name: simvastatin / sitagliptin

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

Not all side effects for Juvisync may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to simvastatin / sitagliptin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by simvastatin / sitagliptin. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking simvastatin / sitagliptin:

More common
  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fainting
  • fast or irregular heartbeat
  • headache
  • increased hunger
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • unusual tiredness or weakness
Less common
  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • dry mouth
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • increased thirst
  • increased urination
  • loss of consciousness
  • lower back or side pain
  • stomachache
  • sweating
  • swelling
  • troubled breathing
  • unexplained weight loss
  • vomiting
  • Bloating
  • constipation
  • dark-colored urine
  • fever
  • indigestion
  • loss of appetite
  • muscle cramps or spasms
  • muscle pain, tenderness, wasting, or weakness
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • yellow eyes or skin
Incidence not known
  • Agitation
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • decreased urine output
  • diarrhea
  • difficulty with moving
  • difficulty with swallowing
  • feeling of warmth
  • hives
  • increased sensitivity of the skin to sunlight
  • irritability
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • pinpoint red spots on the skin
  • rapid weight gain
  • red, irritated eyes
  • red, sore, or itching skin
  • red skin lesions, often with a purple center
  • redness of the face, neck, arms, and occasionally, upper chest
  • seizures
  • severe sunburn
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sores, welts, or blisters on the skin
  • swollen glands
  • swollen joints
  • tightness in the chest
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • weakness in the arms, hands, legs, or feet

Some of the side effects that can occur with simvastatin / sitagliptin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Body aches or pain
  • cough that produces mucus
  • ear congestion
  • loss of voice
  • runny or stuffy nose
  • sneezing
Less common
  • Burning feeling in the chest or stomach
  • dizziness or lightheadedness
  • feeling of constant movement of self or surroundings
  • pain or tenderness around the eyes and cheekbones
  • sensation of spinning
  • skin rash that is encrusted, scaly, and oozing
  • tenderness in the stomach area
  • trouble with sleeping
Incidence not known
  • Acid or sour stomach
  • being forgetful
  • belching
  • decreased interest in sexual intercourse
  • excess air or gas in the stomach or intestines
  • full feeling
  • hair loss
  • heartburn
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • passing gas
  • problems with memory
  • stomach discomfort, upset, or pain
  • thinning of the hair

For Healthcare Professionals

Applies to simvastatin / sitagliptin: oral tablet


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


Very common (10% or more): Eczema
Uncommon (0.1% to 1%): Rash

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


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


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

Postmarketing reports: Erectile dysfunction, gynecomastia[Ref]


Very common (10% or more):Elevation of creatinine kinase (CK)
Frequency not reported: Elevated alkaline phosphatase and gamma-glutamyl transpeptidase

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.


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]

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

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


Common (1% to 10%): Abdominal pain, constipation, nausea, flatulence, gastritis
Uncommon (0.1% to 1%): Acid regurgitation, diarrhea, dyspepsia

Common (1% to 10%): Abdominal pain, constipation, nausea, flatulence
Uncommon (0.1% to 1%): Acid regurgitation, diarrhea, dyspepsia, pancreatitis

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


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


Common (1% to 10%): Hypoglycemia

Nervous system

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

Common (1% to 10%): Headache

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


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

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

Postmarketing reports: Interstitial lung disease[Ref]


Uncommon (0.1% to 1%): Elevated transaminases

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


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).

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


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


Cognitive impairment is reversible up on statin discontinuation.

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

Postmarketing reports: Depression


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:" ([2015, Aug 28]):

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