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Simcor (Simvastatin / Niacin) - Side Effects and Adverse Reactions




In a controlled clinical study, 14% of patients randomized to SIMCOR discontinued therapy due to an adverse event. Flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse reactions, occurring in up to 59% of patients treated with SIMCOR. Spontaneous reports with niacin extended-release and clinical studies of SIMCOR suggest that flushing may be accompanied by symptoms of dizziness or syncope, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema.

Clinical Studies 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.

The safety data described below reflect exposure to SIMCOR in 403 patients in a controlled study for a period of 6 months.

Flushing: Flushing (warmth, redness, itching and/or tingling) occurred in up to 59% of patients treated with SIMCOR. Flushing resulted in study discontinuation for 6.0% of patients.

More Common Adverse Reactions: In addition to flushing, adverse reactions occurring in ≥ 3% of patients (irrespective of investigator causality) treated with SIMCOR are shown in Table 3 below:

Table 3. Adverse Reactions Occurring in ≥ 3% of Patients in a Controlled Clinical Trial
Adverse Event SIMCOR overall * Simvastatin overall **
* SIMCOR overall included all doses from 500/20 mg to 2000/40 mg
** Simvastatin overall included 20 mg, 40 mg, and 80 mg doses
Total Number of Patients N=403 N=238


18 (4.5%)

11 (4.6%)


13 (3.2%)

0 (0.0%)


13 (3.2%)

10 (4.2%)

Back Pain

13 (3.2%)

5 (2.1%)


12 (3.0%)

7 (2.9%)


In pre-marketing controlled clinical studies and their open extensions (2,423 patients with mean duration of follow-up of approximately 18 months) 1.4% of patients discontinued due to adverse reactions. The most commonly reported adverse reactions (incidence > 1%) in simvastatin controlled clinical trials were: headache (3.5%), abdominal pain (3.5%), constipation (2.3%), upper respiratory infection (2.1%), diarrhea (1.9%), and flatulence (1.9%).

Niacin Extended-Release

In placebo-controlled clinical trials (n=245), flushing episodes were the most common treatment-emergent adverse events (up to 88% of patients) for niacin extended-release. Other adverse events occurring in 5% or greater of patients treated with niacin extended-release are headache (9%), diarrhea (7%), nausea (5%), rhinitis (5%), and dyspepsia (4%) at a maintenance dose of 1000mg daily.

Clinical Laboratory Abnormalities:



Elevations in serum transaminases [See Warnings and Precautions ], CK, fasting glucose, uric acid, alkaline phosphatase, LDH, amylase, γ-glutamyl transpeptidase, bilirubin, and reductions in phosphorus, and abnormal thyroid function tests.


Reductions in platelet counts and prolongation of PT. [See Warnings and Precautions ]

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. Hypersensitivity reaction including one or more of the following features: anaphylaxis, angioedema, lupus erythematous-like syndrome, vasculitis, purpura, thrombocytopenia, leucopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, photosensitivity, chills, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, urticaria, fever, dyspnea, and arthralgia; pancreatitis, hepatitis, hepatic failure, pruritus, cataracts, polymyositis, dermatomyositis, polymyalgia rheumatica, global amnesia, tendon rupture, peripheral neuropathy, memory impairment.


The following additional adverse reactions have been identified during post-approval use of NIASPAN. Hypersensitivity reaction including one or more of the following features: anaphylaxis, dyspnea, angioedema, tongue edema, larynx edema, face edema, laryngismus; tachycardia, atrial fibrillation, other cardiac arrhythmias, palpitations, hypotension, postural hypotension, dizziness, syncope, flushing, burning sensation/skin burning sensation, paresthesia, urticaria, vesiculobullous rash, maculopapular rash, sweating, dry skin, skin discoloration, blurred vision, macular edema, myalgia, myopathy, peptic ulcers, eructation, flatulence, hepatitis, jaundice, peripheral edema, asthenia, nervousness, insomnia, migraine, gout, and decreased glucose tolerance.


Below is a sample of reports where side effects / adverse reactions may be related to Simcor. The information is not vetted and should not be considered as verified clinical evidence.

Possible Simcor side effects / adverse reactions in 55 year old male

Reported by a consumer/non-health professional from United States on 2011-10-11

Patient: 55 year old male weighing 51.7 kg (113.8 pounds)

Reactions: Back Pain, Myalgia, Asthenia

Suspect drug(s):

Possible Simcor side effects / adverse reactions in male

Reported by a physician from United States on 2011-12-19

Patient: male

Reactions: Myalgia, Muscular Weakness

Suspect drug(s):
    Administration route: Oral

    Indication: Type 2 Diabetes Mellitus

    Indication: Type 2 Diabetes Mellitus

Metformin HCL
    Indication: Type 2 Diabetes Mellitus

Regular Insulin
    Indication: Type 2 Diabetes Mellitus


Other drugs received by patient: Aspirin; Niacin; Saxagliptin Code NOT Broken

Possible Simcor side effects / adverse reactions in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-01-29

Patient: 56 year old female

Reactions: Weight Decreased, Flushing, Nausea, Pain in Extremity, Urinary Tract Infection, Constipation, Decreased Appetite

Suspect drug(s):
    Indication: Ankylosing Spondylitis
    Start date: 2011-09-01
    End date: 2011-11-23

    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Synthroid; Wellbutrin; Vitamin D; Prilosec OTC; Trazodone HCL; Zoloft; Calcium; Propranolol; Prilosec OTC; Vitamin B-12; Cytomel; Ativan

See index of all Simcor side effect reports >>

Drug label data at the top of this Page last updated: 2010-08-06

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