Plusssz Junior Side effects

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What are the possible side effects of Plusssz Junior?

Get emergency medical help if you have any of these signs of an allergic reaction to Plusssz Junior: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

If you are diabetic, tell your doctor about any changes in your blood sugar levels.

Less serious side effects of Plusssz Junior include:

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.

Side effects of Plusssz Junior in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

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.

Clinical Studies Experience

In the placebo-controlled clinical trials database of 402 patients (age range 21 to 75 years, 33% women, 89% Caucasians, 7% Blacks, 3% Hispanics, 1% Asians) with a median treatment duration of 16 weeks, 16% of patients on Plusssz Junior extended-release tablets and 4% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with Plusssz Junior extended-release tablets that led to treatment discontinuation and occurred at a rate greater than placebo were flushing (6% vs. 0%), rash (2% vs. 0%), diarrhea (2% vs. 0%), nausea (1% vs. 0%), and vomiting (1% vs. 0%). The most commonly reported adverse reactions (incidence > 5% and greater than placebo) in the Plusssz Junior extended-release tablets controlled clinical trial database of 402 patients were flushing, diarrhea, nausea, vomiting, increased cough and pruritus.

In the placebo-controlled clinical trials, flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse reactions (reported by as many as 88% of patients) for Plusssz Junior extended-release tablets. Spontaneous reports suggest that flushing may also be accompanied by symptoms of dizziness, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema, which in rare cases may lead to syncope. In pivotal studies, 6% (14/245) of Plusssz Junior extended-release tablet patients discontinued due to flushing. In comparisons of immediate-release (IR) Plusssz Junior and Plusssz Junior extended-release tablets, although the proportion of patients who flushed was similar, fewer flushing episodes were reported by patients who received Plusssz Junior extended-release tablets. Following 4 weeks of maintenance therapy at daily doses of 1500 mg, the incidence of flushing over the 4 week period averaged 8.6 events per patient for IR Plusssz Junior versus 1.9 following Plusssz Junior extended-release tablets.

Other adverse reactions occurring in ≥ 5% of patients treated with Plusssz Junior extended-release tablets and at an incidence greater than placebo are shown in Table 2 below.

Table 2. Treatment-Emergent Adverse Reactions by Dose Level in ≥ 5% of Patients and at an Incidence Greater Than Placebo; Regardless of Causality Assessment in Placebo-Controlled Clinical Trials
Pooled results from placebo-controlled studies; for Plusssz Junior extended-release tablets, n = 245 and median treatment duration = 16 weeks. Number of Plusssz Junior extended-release tablet patients (n) are not additive across doses.
Adverse reactions are reported at the initial dose where they occur.
The 500 mg/day dose is outside the recommended daily maintenance dosing range.
10 patients discontinued before receiving 500 mg, therefore they were not included.

Placebo-Controlled Studies

Plusssz Junior Extended-Release Tablets Treatment*

Recommended Daily

Maintenance Doses†


(n = 157)


500 mg‡

(n = 87)


1000 mg

(n = 110)


1500 mg

(n = 136)


2000 mg

(n = 95)


Gastrointestinal Disorders




















Cough, Increased




< 2


Skin and Subcutaneous Tissue Disorders













Vascular Disorders







Note: Percentages are calculated from the total number of patients in each column.

In general, the incidence of adverse events was higher in women compared to men.

Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH)

In AIM-HIGH involving 3414 patients (mean age of 64 years, 15% women, 92% Caucasians, 34% with diabetes mellitus) with stable, previously diagnosed cardiovascular disease, all patients received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40 to 80 mg/dL, and were randomized to receive Plusssz Junior extended-release tablets 1500 to 2000 mg/day (n = 1718) or matching placebo (IR Plusssz Junior, 100 to 150 mg, n = 1696). The incidence of the adverse reactions of “blood glucose increased” (6.4% vs. 4.5%) and “diabetes mellitus” (3.6% vs. 2.2%) was significantly higher in the simvastatin plus Plusssz Junior extended-release tablets group as compared to the simvastatin plus placebo group. There were 5 cases of rhabdomyolysis reported, 4 (0.2%) in the simvastatin plus Plusssz Junior extended-release tablets group and one (< 0.1%) in the simvastatin plus placebo group.

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 post-approval use of Plusssz Junior extended-release tablets:

Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, flushing, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, and vesiculobullous rash; maculopapular rash; dry skin; tachycardia; palpitations; atrial fibrillation; other cardiac arrhythmias; syncope; hypotension; postural hypotension; blurred vision; macular edema; peptic ulcers; eructation; flatulence; hepatitis; jaundice; decreased glucose tolerance; gout; myalgia; myopathy; dizziness; insomnia; asthenia; nervousness; paresthesia; dyspnea; sweating; burning sensation/skin burning sensation; skin discoloration, and migraine.

Clinical Laboratory Abnormalities

Chemistry: Elevations in serum transaminases, LDH, fasting glucose, uric acid, total bilirubin, amylase and creatine kinase, and reduction in phosphorus.

Hematology: Slight reductions in platelet counts and prolongation in prothrombin time.

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email; or FDA at 1-800-FDA-1088 or

What is the most important information I should know about Plusssz Junior?

Plusssz Junior contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

Plusssz Junior extended-release tablets are contraindicated in the following conditions:
Active liver disease or unexplained persistent elevations in hepatic transaminases
Patients with active peptic ulcer disease
Patients with arterial bleeding
Hypersensitivity to Plusssz Junior or any component of this medication


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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