Simvastatin

More frequently reported side effects include: eczema and increased creatine phosphokinase in blood specimen. See below for a comprehensive list of adverse effects.

Applies to simvastatin: oral suspension, oral tablet

Along with its needed effects, simvastatin 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:

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 side effects of simvastatin 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:

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

Applies to simvastatin: oral suspension, oral tablet

The more commonly reported adverse effects have included upper respiratory infection, headache, abdominal pain, constipation, and nausea.

This drug causes dose-related myopathy which, in rare cases maybe severe and sometimes take the form of rhabdomyolysis with or without renal failure secondary to myoglobinuria; rarely fatalities have occurred. The incidence of myopathy with the 80 mg dose has been reported as disproportionately higher than that observed at lower doses and the risk of myopathy with simvastatin 80 mg/day is greater compared with other statins with similar or greater LDL-C lowering efficacy.

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Myopathy

Frequency not reported: Elevations in creatine kinase, myopathy, dermatomyositis, arthralgia, tendon rupture

Postmarketing reports: Muscle cramps, myalgia, rhabdomyolysis

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

Postmarketing reports: Hepatic failure, hepatitis, jaundice

Persistent elevations in transaminases of up to 3 times the upper limit of normal (3xULN) have been reported in 1% of patients. With therapy discontinuation or interruption, transaminase levels generally returned to pretreatment levels. There have been rare postmarketing reports of hepatic failure.

Common (1% to 10%): Constipation, nausea, flatulence, diarrhea, dyspepsia, abdominal pain, gastritis

Frequency not reported: Anorexia

Postmarketing reports: Pancreatitis, vomiting

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

Postmarketing reports: Anemia

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

Frequency not reported: Cognitive impairment, cranial nerve dysfunction, tremor, vertigo, memory loss, paraesthesias, peripheral neuropathy, peripheral nerve palsy

Postmarketing reports: Dizziness, paresthesia, peripheral neuropathy, cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion)

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

Common (1% to 10%): Angina, edema, atrial fibrillation

Common (1% to 10%): Eczema

Frequency not reported: Pruritic rash, erythema multiform including Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura

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

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

Postmarketing reports: Hypersensitivity syndrome which has included some of the follow features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme including Stevens-Johnson syndrome

Postmarketing reports: Immune-mediated necrotizing myopathy

Frequency not reported: Progression of cataracts, ophthalmoplegia

Common (1%to 10%): Insomnia

Postmarketing reports: Depression

Common (1% to 10%): Urinary tract infection

Frequency not reported: Impotence, testicular pain, proteinuria

Postmarketing reports: Erectile dysfunction

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

Common (1% to 10%): Diabetes mellitus

Frequency not reported: HbA1c and fasting serum glucose levels elevations

Common (1% to 10%): Respiratory tract infection, bronchitis, sinusitis

Postmarketing reports: Interstitial lung disease

Frequency not reported: Asthenia