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

 
 



ADVERSE REACTIONS

Overview

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, chills, and/or edema.

Clinical Studies Experience

SIMCOR

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 PatientsN=403N=238

Headache

18 (4.5%)

11 (4.6%)

Pruritus

13 (3.2%)

0 (0.0%)

Nausea

13 (3.2%)

10 (4.2%)

Back Pain

13 (3.2%)

5 (2.1%)

Diarrhea

12 (3.0%)

7 (2.9%)

Simvastatin

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:

SIMCOR

Chemistry

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.

Hematology

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.

Simvastatin

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.

NIASPAN

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, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, vesiculobullous rash, palpitations, syncope, hypotension, orthostasis, decreased glucose tolerance, gout, hepatitis, skin discoloration, rhabdomyolysis, amblyopia, and insomnia.



REPORTS OF SUSPECTED SIMCOR SIDE EFFECTS / ADVERSE REACTIONS

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):
Simcor



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):
Crestor
    Administration route: Oral

Glyburide
    Indication: Type 2 Diabetes Mellitus

Lantus
    Indication: Type 2 Diabetes Mellitus

Metformin HCL
    Indication: Type 2 Diabetes Mellitus

Regular Insulin
    Indication: Type 2 Diabetes Mellitus

Simcor

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):
Humira
    Indication: Ankylosing Spondylitis
    Start date: 2011-09-01
    End date: 2011-11-23

Simcor
    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: 2008-04-24

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