Simvastatin Side Effects

It is possible that some side effects of simvastatin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to simvastatin: oral tablet, oral tablet disintegrating

As well as its needed effects, simvastatin may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking simvastatin, check with your doctor immediately:

More common
  • Dizziness
  • fainting
  • fast or irregular heartbeat
Less common
  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • chills
  • cough
  • dark-colored urine
  • difficult, burning, or painful urination
  • difficulty with breathing
  • difficulty with moving
  • dry mouth
  • ear congestion
  • fever
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • joint pain
  • loss of consciousness
  • lower back or side pain
  • muscle cramps, spasms, or stiffness
  • muscular pain, tenderness, wasting, or weakness
  • nasal congestion
  • nausea
  • runny nose
  • sneezing
  • sore throat
  • stomachache
  • sweating
  • swelling
  • swollen joints
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • bloating
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • constipation
  • diarrhea
  • difficulty with swallowing
  • general tiredness and weakness
  • indigestion
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • skin rash, hives, or itching
  • sores, ulcers, or white spots in the mouth or on the lips
  • tightness in the chest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • weakness in the arms, hands, legs, or feet
  • yellow eyes or skin

Some simvastatin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Acid or sour stomach
  • belching
  • burning feeling in the chest or stomach
  • dizziness or lightheadedness
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • full feeling
  • heartburn
  • lack or loss of strength
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • sensation of spinning
  • skin rash, encrusted, scaly, and oozing
  • stomach discomfort, upset, or pain
  • tenderness in the stomach area
  • trouble sleeping
Incidence not known
  • Being forgetful
  • depression
  • discoloration of the skin
  • hair loss or thinning of the hair
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance

For Healthcare Professionals

Applies to simvastatin: oral tablet

Musculoskeletal

Frequency not reported: Elevations in creatine kinase, myopathy, dermatomyositis, rhabdomyolysis, arthralgia, myalgia, tendon rupture, dermatomyositis, (exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50 years of age)[Ref]

Simvastatin has been associated with rare cases of severe myopathy and rhabdomyolysis. This is accompanied by elevations in creatine kinase, myoglobinuria, and proteinuria, as well as renal failure. Experience with HMG-CoA reductase inhibitors indicates that concomitant use with gemfibrozil, nicotinic acid, cyclosporin, or erythromycin may increase the incidence and the severity of musculoskeletal side effects.

Patients should be instructed to report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and if elevated, simvastatin should be discontinued. The value of regular monitoring of creatine kinase is not known. In some studies, elevations in creatine kinase occurred in up to 5.2% of patients on simvastatin. In most cases, these elevations were mild, transient, and not associated with clinical symptoms.[Ref]

Hepatic

Persistent elevations in liver function tests three times normal values are reported in up to 1.5% of patients on simvastatin in clinical trials. In one study, this led to the discontinuation of simvastatin in 0.6% of patients. In other patients, elevations in liver function tests were transient and returned to normal with continued simvastatin therapy. Liver function tests should be closely monitored. Simvastatin should be discontinued in patients with persistent, significant elevations (3 times normal) in liver function parameters.[Ref]

Common (1% to 10%): Elevations in liver function tests
Frequency not reported: Hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty changes in the liver, cirrhosis, hepatic failure, fulminant hepatic necrosis[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, nausea, flatulence, diarrhea, dyspepsia, abdominal pain
Very rare (less than 0.01%): Protein-losing enteropathy
Frequency not reported: Anorexia, pancreatitis, vomiting[Ref]

Hematologic

Frequency not reported: Hemolytic anemia, thrombocytopenia, leucopenia, thrombotic thrombocytopenic purpura (TTP)[Ref]

Nervous system

Common (1% to 10%): Headache
Frequency not reported: Cognitive impairment, cranial nerve dysfunction, tremor, vertigo, memory loss, paraesthesias, peripheral neuropathy, peripheral nerve palsy[Ref]

Renal

Frequency not reported: Myoglobinuria, acute renal failure secondary to rhabdomyolysis[Ref]

Cardiovascular

Common (1% to 10%): Angina[Ref]

The Scandinavian Simvastatin Survival Study (4S) demonstrated a 30% reduction in total mortality in patients followed for a median of 5.4 years and a 42% decrease in death from coronary heart disease compared to placebo. Simvastatin reduced the risk of major coronary events by 34%, hospital verified nonfatal myocardial infarction by 37%, and the need for coronary artery bypass graft or angioplasty by 37%, all significant compared to placebo.[Ref]

Dermatologic

Frequency not reported: Eczematous, pruritic rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura, alopecia[Ref]

Endocrine

Frequency not reported: Hypospermia, gynecomastia, thyroid function abnormalities, increases in HbA1c and fasting serum glucose levels. Acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease) has been revealed following simvastatin therapy in at least one presymptomatic patient.[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioedema, urticaria, fever, chills, flushing, malaise, dyspnea[Ref]

Immunologic

Frequency not reported: A case of lupus-like syndrome which has been reported with other HMG-CoA reductase inhibitors, positive ANA, ESR increase, polymyalgia rheumatica, and vasculitis[Ref]

Ocular

Frequency not reported: Progression of cataracts, ophthalmoplegia[Ref]

Psychiatric

Frequency not reported: Depression, suicidal thoughts, delusions, paranoia, agitation, decreased libido, anxiety, insomnia, nightmares[Ref]

Genitourinary

Frequency not reported: Erectile dysfunction, impotence, testicular pain[Ref]

Oncologic

Frequency not reported: Tumor growth, liver, thyroid, lung adenomas, carcinomas[Ref]

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