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Zocor

Zocor (Simvastatin) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Zocor Side Effects Center

What Is Zocor?

Zocor (simvastatin) is a statin that lowers lipids and cholesterol levels 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 years old). Zocor is available in generic form.

What Are Side Effects of Zocor?

Common side effects of Zocor include:

Contact your doctor if you have severe side effects of Zocor including:

Dosage for Zocor

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.

What Drugs, Substances, or Supplements Interact with Zocor?

Zocor may interact with colchicine, digoxin, digitalis, blood thinners, fenofibric acid or fenofibrate, antifungals, medicines that contain niacin, drugs that weaken your immune system (such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection), or other "statin" medications. Tell your doctor all medications and supplements you use.

Zocor During Pregnancy and Breastfeeding

Do not take Zocor if you are pregnant. Stop taking Zocor and tell your doctor right away if you become pregnant. Zocor can harm a fetus or cause birth defects. Use effective birth control to avoid pregnancy while you are taking Zocor. Zocor may pass into breast milk and could harm a nursing baby. Breastfeeding while taking Zocor is not recommended.

Additional Information

Our Zocor (simvastatin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Zocor Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

  • muscle weakness in your hips, shoulders, neck, and back;
  • trouble lifting your arms, trouble climbing or standing; or
  • liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache;
  • nausea, stomach pain, constipation; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zocor (Simvastatin)

 

Zocor Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials 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

ZOCOR
(N = 2,221)
%		Placebo
(N = 2,223)
%
Body as a Whole
  Edema/swelling2.72.3
  Abdominal pain5.95.8
Cardiovascular System Disorders
  Atrial fibrillation5.75.1
Digestive System Disorders
  Constipation2.21.6
  Gastritis4.93.9
Endocrine Disorders
  Diabetes mellitus4.23.6
Musculoskeletal Disorders
  Myalgia3.73.2
Nervous System/ Psychiatric Disorders
  Headache2.52.1
  Insomnia4.03.8
  Vertigo4.54.2
Respiratory System Disorders
  Bronchitis6.66.3
  Sinusitis2.31.8
Skin / Skin Appendage Disorders
  Eczema4.53.0
Urogenital System Disorders
  Infection, urinary tract3.23.1

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.

Other adverse reactions reported in clinical trials were: diarrhea, rash, dyspepsia, flatulence, and asthenia.

Laboratory Tests

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].

Postmarketing Experience

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)

&Copy; Zocor Patient Information is supplied by Cerner Multum, Inc. and Zocor Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.