Simcor Side Effects

Please note - some side effects for Simcor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Simcor - for the Consumer

Simcor

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Simcor:

Back pain; diarrhea; dizziness; flushing (eg, itching, redness, tingling, warmth); headache; nausea; runny or stuffy nose; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Simcor:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or persistent tingling; change in the amount of urine produced; dark or red-colored urine; dark, tarry, or bloody stools; decreased sexual ability; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased sweating; joint pain; loss of appetite; memory problems; muscle pain, tenderness, or weakness (with or without fever and fatigue); pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness or light-headedness; severe or persistent nausea or stomach or back pain; shortness of breath; swelling of the hands, legs, or feet; trouble sleeping; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; vomiting; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Simcor Side Effects - for the Professional

Simcor

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, burning sensation/skin burning sensation, 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 4 below:

Table 4 Adverse Reactions Occurring in ≥ 3% of Patients in a Controlled Clinical Trial

Adverse Event	Simcor overall *	Simvastatin overall **
Total Number of Patients	N=403	N=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%)
* Simcor overall included all doses from 500/20 mg to 2000/40 mg ** Simvastatin overall included 20 mg, 40 mg, and 80 mg doses

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%).

Other Clinical Studies

In a clinical trial in which 12,064 patients with a history of myocardial infarction were treated with simvastatin (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.

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 (5.2)], 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 (5.3)]

Postmarketing Experience

See also the full prescribing information for niacin extended release (Niaspan) and simvastatin products.

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, erectile dysfunction, depression, interstitial lung disease, alopecia, a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails), muscle cramps, vomiting, malaise.

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, 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.

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Side Effects by Body System - for Healthcare Professionals

General

Niacin-simvastatin treatment was discontinued by 14% of patients in a controlled clinical trial due to an adverse event. Flushing episodes (including warmth, redness, itching, and/or tingling) were the most common side effects reported by patients using niacin-simvastatin.

Musculoskeletal

Musculoskeletal side effects have included back pain (3.2%), myopathy, and rhabdomyolysis have been associated with simvastatin therapy. The risk of myopathy/rhabdomyolysis is dose related and is increased by concomitant use of simvastatin with potent Inhibitors of CYP450 3A4, as well as cyclosporine or danazol, particularly with higher doses of simvastatin.

Hepatic

Liver function tests should be performed before treatment begins, every 12 weeks for the first 6 months, and periodically thereafter (e.g., at approximately 6-month intervals). Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality returns to normal. If a persistent increase in transaminase levels is seen (e.g., three times the upper limit of normal), or if transaminase elevations are associated with symptoms of nausea, fever, and/or malaise, withdrawal of niacin-simvastatin therapy is recommended.

Severe hepatic toxicity has occurred in patients substituting sustained-release niacin for immediate-release niacin at equivalent doses. In addition, persistent elevations in hepatic transaminase can occur during niacin-simvastatin therapy.

Dermatologic

Dermatologic side effects including flushing (59%) and pruritus (3.2%) were reported in patients receiving the combination niacin-simvastatin product. Flushing episodes have also been associated with niacin monotherapy (in up to 88% of patients).

Other

Other side effects including headache (4.5%) and back pain (3.2%) have been associated with the combination niacin-simvastatin product.

Gastrointestinal

Gastrointestinal side effects associated with administration of the combination product have included nausea (3.2%) and diarrhea (3%). Diarrhea has also been associated with each of the individual components of the drug. Abdominal pain, constipation, and flatulence have also been associated with simvastatin monotherapy, while nausea and dyspepsia have been associated with niacin monotherapy.

Respiratory

Respiratory side effects including upper respiratory infection and rhinitis have been associated with simvastatin and niacin, respectively.

Metabolic

Metabolic side effects including increased serum glucose levels have been associated with niacin therapy. Therefore, glucose levels should be closely monitored in diabetic or potentially diabetic patients particularly during the first few months of use.

Hypersensitivity

Hypersensitivity side effects associated with simvastatin including one or more of the following features reported postmarketing have included: 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, erectile dysfunction, depression, interstitial lung disease, alopecia, a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails), muscle cramps, vomiting, malaise.

Hypersensitivity side effects associated with niacin including one or more of the following features reported postmarketing have included: 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.

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