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 |
| Endocrine Disorders|
| Musculoskeletal Disorders|
| Nervous System / Psychiatric Disorders|
| Respiratory System Disorders|
| Skin / Skin Appendage Disorders|
| Urogenital System Disorders|
Infection, urinary tract
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
Other adverse reactions reported in clinical trials were: diarrhea, rash, dyspepsia, flatulence, and asthenia.
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 were being 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, memory impairment, paresthesia, peripheral neuropathy, vomiting and anemia, rhabdomyolysis, hepatitis/jaundice, hepatic failure, depression.
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.
REPORTS OF SUSPECTED ZOCOR SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Zocor. The information is not vetted and should not be considered as verified clinical evidence.
Possible Zocor side effects / adverse reactions in 78 year old female
Reported by a physician from United States on 2011-07-11
Patient: 78 year old female weighing 55.0 kg (121.0 pounds)
Reactions: Atelectasis, Gastrointestinal Haemorrhage, Rhabdomyolysis, Dyslipidaemia, Osteoporosis, Dizziness Postural, Tricuspid Valve Incompetence, Chronic Obstructive Pulmonary Disease, Hypomagnesaemia, Thyroid Mass, Erosive Oesophagitis, Renal Failure Acute, Type 2 Diabetes Mellitus, Peptic Ulcer, Helicobacter Infection, Dehydration, Mitral Valve Incompetence, Aortic Valve Incompetence, Hypertension
Adverse event resulted in: hospitalization
Administration route: Oral
Indication: Coronary Artery Disease
End date: 2010-05-01
Administration route: Oral
End date: 2010-05-01
Other drugs received by patient: Verapamil
Possible Zocor side effects / adverse reactions in 76 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-03
Patient: 76 year old female weighing 67.0 kg (147.4 pounds)
Other drugs received by patient: Beclomethasone Dipropionate; Gabapentin; Ramipril; Diltiazem Hydrochloride; Omeprazole; Zopiclone; Calcium Carbonate and Cholecalciferol; Hypromellose; Docusate Sodium; Meptazinol
Possible Zocor side effects / adverse reactions in 66 year old female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2011-10-04
Patient: 66 year old female
Other drugs received by patient: Aspirin; Tenoretic 100