Dalfopristin and quinupristin Side Effects

Please note - some side effects for Dalfopristin and quinupristin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects by Body System

General

In a study with 93 patients, 21.5% discontinued treatment due to side effects. The most common side effects were arthralgia, myalgia, nausea, and rash.

Patients have discontinued therapy with dalfopristin-quinupristin as compared to placebo for the following reasons: venous adverse events (9.2% to 12% vs. 2% to 4% placebo), rash (1% to 2% vs. 0.5% to 0.9% placebo), nausea (0.9% to 1.1% vs. 0% to 0.6% placebo), vomiting (0.5% to 0.9% vs. 0% to 0.5% placebo), pain (0.5% to 0.9% vs. 0% placebo), and pruritus (0.5% to 0.9% vs. 0.3% to 0.5% placebo).

Local

Local side effects have frequently included inflammation at the infusion site (42%), pain at the infusion site (40%), infusion site edema (17.3%), and infusion site reaction (13.4%).

The manufacturer recommends flushing of the vein with dextrose in water solution following each infusion of dalfopristin-quinupristin to minimize venous irritation. Consideration should be given to changing the infusion site in patients with moderate to severe venous irritation. Dalfopristin-quinupristin infusion (standard diluent volume of 250 mL) may also be further diluted (500 to 750 mL) in these patients. Venous adverse events occurred predominately in patients who had peripheral infusions, therefore, a peripherally inserted central catheter or a central venous catheter may be utilized in selected patients.

Musculoskeletal

Musculoskeletal side effects have included elevated CPK (>10 times upper limit of normal: 1.6%), and arthralgia, myalgia (some severe), and myasthenia in less than 1% of patients. Bone pain and neck rigidity have been reported in less than 0.1% of patients.

Some cases noted improvement of symptoms with a reduction in dose frequency to every 12 hours. Resolution of symptoms has been reported following discontinuation of dalfopristin-quinupristin.

One trial with 93 patients reported an incidence of 10.8% and 8.6%, respectively, for arthralgia and myalgia.

Intravenous dalfopristin-quinupristin plus minocycline were associated with myalgia and arthralgia in 36% of neutropenic cancer patients (n=56).

Hepatic

Hepatic side effects have included hyperbilirubinemia (>5 times upper limit of normal) in up to 25% of patients and ALT and AST elevations. Isolated hyperbilirubinemia (primarily conjugated bilirubin) can occur and is thought to be due to dalfopristin-quinupristin competing with bilirubin for excretion. Hepatitis and jaundice have also been reported in less than 0.1% of patients. Elevated alkaline phosphatase (0.3%), GGT (>10 times upper limit of normal: 1.9%), and LDH (>5 times upper limit of normal: 2.6%) have also been reported.

Cardiovascular

Cardiovascular side effects have included palpitations, peripheral edema, and phlebitis in less than 1% of patients. Hypotension has occurred in less than 0.2% of patients. Arrhythmia, cerebral hemorrhage, cerebral vascular accident, heart arrest, pericardial effusion, pericarditis, shock, supraventricular tachycardia, syncope, ventricular extrasystoles, and ventricular fibrillation have been reported in less than 0.1% of patients.

Nervous system

Nervous system side effects have included headache (1.6%). Anxiety, confusion, dizziness, hypertonia, insomnia, leg cramps, paresthesia, and vasodilation have been reported in less than 1% of patients. Convulsion, dysautonomia, encephalopathy, grand mal convulsion, neuropathy, paraplegia, and tremor have been reported in less than 0.1% of patients.

Gastrointestinal

Gastrointestinal side effects have included nausea (4.6%), diarrhea (2.7%), and vomiting (2.7%). Abdominal pain, constipation, dyspepsia, oral moniliasis, pancreatitis, pseudomembranous enterocolitis, and stomatitis have been reported in less than 1% of patients. Gastrointestinal hemorrhage (less than 0.2%) and mesenteric arterial occlusion (less than 0.1%) have also been reported.

Mild cases of pseudomembranous enterocolitis may respond to discontinuation of dalfopristin-quinupristin alone. Moderate to severe cases may require fluid replacement, electrolytes, protein supplementation, and antibiotics for treating C. difficile.

Dermatologic

Dermatologic side effects have included rash (2.5%) and pruritus (1.5%), and skin ulcer (less than 0.1%). Maculopapular rash, sweating, and urticaria have been reported in less than 1% of patients.

Endocrine

Endocrine side effects have included hypoglycemia in less than 0.1% of patients.

Genitourinary

Genitourinary side effects have included hematuria and vaginitis in less than 1% of patients.

Hematologic

Hematologic side effects have included thrombophlebitis (2.4%), and coagulation disorder, hemolysis, hemolytic anemia, hypoplastic anemia, and pancytopenia in less than 0.1% of patients. Decreased hemoglobin (2.6%), increased hematocrit (0.2%), increased platelets (0.2%), and decreased platelets (0.6%), and reversible reticulocytopenia have also been reported.

Hypersensitivity

Hypersensitivity reactions have been reported in less than 1% of patients. Anaphylactoid reaction has been rarely reported (less than 0.1%).

Metabolic

Metabolic side effects have included gout and peripheral edema in less than 1% of patients. Acidosis, alkalosis, hypoglycemia, hyponatremia,hypovolemia, hyperkalemia, and hyperglycemia have also been reported.

Respiratory

Respiratory side effects have included dyspnea and pleural effusion in less than 1% of patients. Apnea, hypoventilation, hypoxia, and respiratory distress syndrome have been reported in less than 0.1%.

Other

Other side effects have included pain (1.5%), and abdominal pain, worsening of underlying illness, chest pain, fever, and infection in less than 1% of patients.

Renal

Renal side effects have included elevations in creatinine (0.1%) and BUN (0.3%).

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