"The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemi"...
Zocor Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Zocor (simvastatin) is a statin that lowers lipids and cholesterol levels. Zocor is available as a generic named simvastatin. Zocor is used in conjunction with lifestyle changes such as a low-fat, low cholesterol diet, and exercise to reduce the chances of cardiovascular disease and ischemic strokes in patients with elevated lipids and cholesterol. Zocor is also used to treat heterozygous familial hypercholesterolemia (HeFH) in adolescents (males and females that are one-year post menarche, 10 to 17 yrs old). Common side effects mainly gastrointestinal such as heartburn, gas, bloating, mild stomach pain, nausea, and constipation or diarrhea.
Zocor tablets are supplied as 5, 10, 20, 40 or 80 mg tablets. Doses range from 5-80 mg per day depending on the patient's response to the drug as measured by repeated blood tests. Zocor should be carefully used with other medications; information regarding maximum Zocor doses with certain drugs should be consulted by the prescribing doctor. Patients should stop using Zocor and contact their prescribing doctor at once if they have any of these serious side effects of allergic reactions (shortness of breath, rash, swelling), atrial fibrillation, muscle pain, tenderness, or weakness with fever or flu symptoms, and dark colored urine. Muscle damage and destruction (myopathy) can occur; liver and kidney problems may also occur. Zocor should not be used in pregnant women and has not been studied in lactating women; its use in the pediatric population is limited to those patients described above.
Our Zocor (simvastatin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Zocor in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking simvastatin and call your doctor at once if you have any of these serious side effects:
- unexplained muscle pain, tenderness, or weakness;
- fever, unusual tiredness, and dark colored urine;
- pain or burning when you urinate;
- swelling, weight gain, urinating less than usual or not at all; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- joint pain, mild muscle pain;
- constipation, stomach pain or indigestion, mild nausea;
- mild skin rash;
- sleep problems (insomnia); or
- cold symptoms such as stuffy nose, sneezing, sore throat.
Read the entire detailed patient monograph for Zocor (Simvastatin) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Zocor Overview - Patient Information: Side Effects
A very small number of people taking simvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.
This drug may infrequently cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms persist after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.
This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Zocor (Simvastatin)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zocor FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In the pre-marketing controlled clinical studies and their open extensions (2,423 patients with median duration of follow-up of approximately 18 months), 1.4% of patients were discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: gastrointestinal disorders (0.5%), myalgia (0.1%), and arthralgia (0.1%). The most commonly reported adverse reactions (incidence ≥ 5%) in simvastatin controlled clinical trials were: upper respiratory infections (9.0%), headache (7.4%), abdominal pain (7.3%), constipation (6.6%), and nausea (5.4%). Scandinavian Simvastatin Survival Study
In 4S involving 4,444 (age range 35-71 years, 19% women, 100% Caucasians) treated with 20-40 mg/day of ZOCOR (n=2,221) or placebo (n=2,223) over a median of 5.4 years, adverse reactions reported in ≥ 2% of patients and at a rate greater than placebo are shown in Table 2.
TABLE 2 : Adverse Reactions Reported Regardless of
Causality by ≥ 2% of Patients Treated with ZOCOR and Greater than Placebo in 4S
(N = 2,221)
(N = 2,223)
|Body as a Whole|
|Cardiovascular System Disorders|
|Digestive System Disorders|
|Nervous System/ Psychiatric Disorders|
|Respiratory System Disorders|
|Skin / Skin Appendage Disorders|
|Urogenital System Disorders|
|Infection, urinary tract||3.2||3.1|
Heart Protection Study
In the Heart Protection Study (HPS), involving 20,536 patients (age range 40-80 years, 25% women, 97% Caucasians, 3% other races) treated with ZOCOR 40 mg/day (n=10,269) or placebo (n=10,267) over a mean of 5 years, only serious adverse reactions and discontinuations due to any adverse reactions were recorded. Discontinuation rates due to adverse reactions were 4.8% in patients treated with ZOCOR compared with 5.1% in patients treated with placebo. The incidence of myopathy/rhabdomyolysis was < 0.1% in patients treated with ZOCOR.
Other Clinical Studies
In a clinical trial in which 12,064 patients with a history of myocardial infarction were treated with ZOCOR (mean follow-up 6.7 years), the incidence of myopathy (defined as unexplained muscle weakness or pain with a serum creatine kinase [CK] > 10 times upper limit of normal [ULN]) in patients on 80 mg/day was approximately 0.9% compared with 0.02% for patients on 20 mg/day. The incidence of rhabdomyolysis (defined as myopathy with a CK > 40 times ULN) in patients on 80 mg/day was approximately 0.4% compared with 0% for patients on 20 mg/day. The incidence of myopathy, including rhabdomyolysis, was highest during the first year and then notably decreased during the subsequent years of treatment. In this trial, patients were carefully monitored and some interacting medicinal products were excluded.
Marked persistent increases of hepatic transaminases have been noted [see WARNINGS AND PRECAUTIONS]. Elevated alkaline phosphatase and γ-glutamyl transpeptidase have also been reported. About 5% of patients had elevations of CK levels of 3 or more times the normal value on one or more occasions. This was attributable to the noncardiac fraction of CK. [See WARNINGS AND PRECAUTIONS]
Adolescent Patients (ages 10-17 years)
In a 48-week, controlled study in adolescent boys and girls who were at least 1 year post-menarche, 10-17 years of age (43.4% female, 97.7% Caucasians, 1.7% Hispanics, 0.6% Multiracial) with heterozygous familial hypercholesterolemia (n=175), treated with placebo or ZOCOR (10-40 mg daily), the most common adverse reactions observed in both groups were upper respiratory infection, headache, abdominal pain, and nausea [see Use In Specific Populations and Clinical Studies].
Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse reactions have been identified during postapproval use of simvastatin: pruritus, alopecia, a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails), dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting, anemia, erectile dysfunction, interstitial lung disease, rhabdomyolysis, hepatitis/jaundice, fatal and non-fatal hepatic failure, and depression.
There have been rare reports of immune-mediated necrotizing myopathy associated with statin use [see WARNINGS AND PRECAUTIONS].
An apparent hypersensitivity syndrome has been reported rarely which has included some of the following 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.
There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Read the entire FDA prescribing information for Zocor (Simvastatin) »
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