Simvastatin / sitagliptin Side Effects

Some side effects of simvastatin / sitagliptin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to simvastatin / sitagliptin: oral tablet

Along with its needed effects, simvastatin / sitagliptin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while 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
Rare
  • 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 side effects of simvastatin / sitagliptin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

Cardiovascular

Simvastatin:
Very common (10% or more): Atrial fibrillation

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)

Endocrine

Simvastatin:
Very common (10% or more): Diabetes mellitus

Genitourinary

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

Simvastatin-sitagliptin:
Postmarketing reports: Erectile dysfunction, gynecomastia

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

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

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

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

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

Renal

Simvastatin-sitagliptin:
Postmarketing reports: Worsening of renal function, including acute renal failure (sometimes requiring dialysis)

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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