Dalfopristin / quinupristin Side Effects

Not all side effects for dalfopristin / quinupristin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to dalfopristin / quinupristin: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by dalfopristin / quinupristin. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking dalfopristin / quinupristin, check with your doctor or nurse immediately:

More common
  • Swelling, redness, or pain at the injection site
Less common
  • Changes in skin color
  • dry, red, hot, or irritated skin
  • joint pain
  • muscle pain
  • pain
  • redness, burning sensation, or pain under the skin usually in the injection site
  • swelling of the foot or leg
  • tenderness
Rare
  • Agitation
  • anxiety
  • back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine
  • bloody, black, or tarry stools
  • blue lips, fingernails, or skin
  • blurred vision
  • bone pain
  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  • chest pain or discomfort
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • chills
  • coma
  • confusion
  • constipation
  • convulsions or seizures
  • cough or hoarseness
  • darkened urine
  • decreased urine output
  • difficult, fast, or labored breathing
  • difficult or painful urination
  • difficulty with moving
  • difficulty with swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • extremely shallow or slow breathing
  • fainting
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • general body swelling
  • general tiredness and weakness
  • hallucinations
  • headache
  • high fever
  • hives
  • inability to speak
  • increased thirst
  • indigestion
  • irritability
  • itching
  • light-colored stools
  • loss of appetite
  • loss of bladder control
  • loss of consciousness
  • loss of strength or energy
  • lower back or side pain
  • muscle pain or cramps
  • muscle stiffness or weakness
  • nausea or vomiting
  • no blood pressure or pulse
  • nosebleeds
  • not breathing
  • pain in the joints
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • problems with bleeding or clotting
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • redness, burning sensation, or pain in the vagina
  • sensation of pins and needles
  • severe bloody diarrhea
  • severe or sudden headache
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • skin rash
  • skin rash with red patches
  • slurred speech
  • sore throat
  • sores on the skin
  • sores, ulcers, or white spots on the lips or in the mouth
  • stabbing pain
  • stiff neck
  • stopping of the heart
  • sweating
  • swelling of the face, ankles, or hands
  • swollen glands
  • temporary blindness
  • tightness in the chest
  • tingling of the hands or feet
  • total body jerking
  • trembling or shaking of the hands or feet
  • troubled breathing
  • unconsciousness
  • unexplained bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • upper right abdominal or stomach pain
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
  • weakness in the arm or leg on one side of the body, sudden and severe
  • wheezing
  • worsening of the underlying disease
  • yellowing of the eyes or skin
Incidence not known
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some of the side effects that can occur with dalfopristin / quinupristin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Rare
  • Acid or sour stomach
  • ankle, knee, or great toe joint pain
  • belching
  • cold sweats
  • cool, pale skin
  • cramps in the legs
  • depression
  • excessive muscle tone
  • heartburn
  • hives or welts
  • increased hunger
  • itching of the vagina or genital area
  • joint stiffness or swelling
  • lower back or side pain
  • muscle tension or tightness
  • nightmares
  • pain during sexual intercourse
  • redness of the skin
  • shakiness
  • sleeplessness
  • stomach discomfort, upset, or pain
  • sweating
  • swelling or inflammation of the mouth
  • thick, white vaginal discharge with no odor or with a mild odor
  • trouble sleeping
  • unable to sleep
  • white patches in the mouth, tongue, or throat

For Healthcare Professionals

Applies to dalfopristin / quinupristin: intravenous powder for injection

General

In all 5 comparative studies, patients discontinued therapy with dalfopristin-quinupristin as compared to comparator for the following reasons: venous adverse events (9.2% versus 2% comparator), rash (1% versus 0.5% comparator), nausea (0.9% versus 0.6% comparator), vomiting (0.5% versus 0.5% comparator), pain (0.5% versus 0% comparator), and pruritus (0.5% versus 0.3% comparator).

In the 2 comparative studies for complicated skin and skin structure infections (cSSSI), the side effect profile observed differed significantly from the profile observed in the other comparative studies. In these 2 comparative cSSSI studies, patients discontinued therapy with dalfopristin-quinupristin as compared to comparator for the following reasons: venous adverse events (12% versus 2% comparator), rash (2% versus 0.9% comparator), nausea (1.1% versus 0% comparator), vomiting (0.9% versus 0% comparator), pain (0.9% versus 0% comparator), and pruritus (0.9% versus 0.5% comparator). Venous adverse events were mainly observed in patients with peripheral infusions.

In noncomparative studies, approximately one-third of patients discontinued therapy due to side effects; however, the discontinuation rate due to side effects possibly or probably related to dalfopristin-quinupristin was about 5%. The side effects leading to therapy discontinuation included increased total bilirubin (2.7%), increased conjugated bilirubin (2.3%), treatment-related arthralgia (2.3%), and treatment-related myalgia (1.8%). High baseline total and conjugated bilirubin levels were recorded in 46.5% and 59% of patients, respectively, prior to study entry.

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.[Ref]

Local

Local side effects have frequently included inflammation at the infusion site (all comparative studies: 42%; comparative cSSSI studies: 44.7%), pain at the infusion site (all comparative studies: 40%; comparative cSSSI studies: 38.2%), infusion site edema (all comparative studies: 17.3%; comparative cSSSI studies: 18%), and infusion site reaction (all comparative studies: 13.4%; comparative cSSSI studies: 11.6%).[Ref]

The manufacturer recommends flushing of the vein with 5% 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.[Ref]

Musculoskeletal

Some cases of arthralgia and myalgia 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).[Ref]

Musculoskeletal side effects have included arthralgia (up to 7.8%; severe: 3.3%), arthralgia and myalgia (up to 7.4%), myalgia (up to 5.1%; severe: 3.1%), elevated creatine phosphokinase (greater than 10 times ULN; 1.6%), and myasthenia (less than 1%). Bone pain and neck rigidity have been reported in less than 0.1% of patients.[Ref]

Gastrointestinal

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.[Ref]

Gastrointestinal side effects have included nausea (all comparative studies: 4.6%; comparative cSSSI studies: 4%; noncomparative studies: up to 4.9%), vomiting (all comparative studies: 2.7%; comparative cSSSI studies: 3.7%), and diarrhea (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%), mesenteric arterial occlusion (less than 0.1%), and Clostridium difficile associated diarrhea have been reported.[Ref]

Hepatic

Hepatic side effects have included increased conjugated bilirubin (greater than 5 times ULN; 3.1%), gamma-glutamyltransferase (greater than 10 times ULN; 1.9%), total bilirubin (greater than 5 times ULN; 0.9%), AST (greater than 10 times ULN; 0.9%), and ALT (greater than 10 times ULN; 0.4%). Irrespective of relationship to dalfopristin-quinupristin, increased total bilirubin (greater than 5 times ULN; 25%) and conjugated bilirubin (greater than 5 times ULN; 34.6%) were reported during noncomparative studies. 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 been reported in less than 0.1% of patients.[Ref]

High baseline total and conjugated bilirubin levels were recorded in 46.5% and 59% of patients, respectively, prior to noncomparative study entry.[Ref]

Cardiovascular

Cardiovascular side effects have included thrombophlebitis (all comparative studies: 2.4%), thrombus or thrombophlebitis (comparative cSSSI studies: 1.7%), and hypotension (less than 0.2%). Palpitations, vasodilation, and phlebitis have been reported in less than 1% of patients. Arrhythmia, cerebral hemorrhage, cerebrovascular accident, heart arrest, pericardial effusion, pericarditis, supraventricular tachycardia, ventricular extrasystoles, and ventricular fibrillation have been reported in less than 0.1% of patients.[Ref]

Dermatologic

Dermatologic side effects have included rash (all comparative studies: 2.5%; comparative cSSSI studies: 3.1%), pruritus (1.5%), and skin ulcer (less than 0.1%). Maculopapular rash, sweating, and urticaria have been reported in less than 1% of patients.[Ref]

Hematologic

Hematologic side effects have included decreased hemoglobin (less than 8 g/dL; 2.6%), decreased platelets (less than 50,000/mm3; 0.6%), increased hematocrit (greater than 60%; 0.2%), increased platelets (greater than 1,000,000/mm3; 0.2%), and reversible reticulocytopenia. Coagulation disorder, hemolysis, hemolytic anemia, hypoplastic anemia, and pancytopenia have been reported in less than 0.1% of patients.[Ref]

Metabolic

Metabolic side effects have included increased lactate dehydrogenase (greater than 5 times ULN; 2.6%), blood glucose (greater than 22.2 mmol/L; 1.3%), alkaline phosphatase (greater than 5 times ULN; 0.3%), bicarbonates (greater than 40 mmol/L; 0.3%), and potassium (greater than 6 mmol/L; 0.3%), and decreased bicarbonates (less than 10 mmol/L; 0.5%), sodium (less than 120 mmol/L; 0.5%), carbon dioxide (less than 15 mmol/L; 0.2%), and blood glucose (less than 2.2 mmol/L; 0.1%). Gout has been reported in less than 1% of patients. Acidosis, hypoglycemia, hyponatremia, and hypovolemia have been reported in less than 0.1% of patients. Alkalosis, hyperkalemia, and hyperglycemia have also been reported.[Ref]

Nervous system

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

Other

Other side effects have included pain (all comparative studies: 1.5%; comparative cSSSI studies: 3.1%) and shock (less than 0.1%). Abdominal pain, worsening of underlying illness, chest pain, fever, peripheral edema, and infection have been reported in less than 1% of patients.[Ref]

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (less than 1%) and anaphylactoid reaction (less than 0.1%). Angioedema and anaphylactic shock have been reported during postmarketing experience.[Ref]

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%.[Ref]

Genitourinary

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

Psychiatric

Psychiatric side effects have included anxiety in less than 1% of patients.

Renal

Renal side effects have included elevated BUN (35.5 mmol/L or greater; 0.3%) and creatinine (440 mcmol/L or greater; 0.1%).[Ref]

References

1. Griswold MW, Lomaestro BM, Briceland LL "Quinupristin-dalfopristin (RP 59500): an injectable streptogramin combination." Am J Health Syst Pharm 53 (1996): 2045-53

2. "Product Information. Synercid (dalfopristin-quinupristin)" Rhone-Poulenc Rorer, Collegeville, PA.

3. Fuller RE, Drew RH, Perfect JR "Treatment of vancomycin-resistant enterococci, with a focus on quinupristin-dalfopristin." Pharmacotherapy 16 (1996): 584-92

4. Drew RH, Perfect JR, Srinath L, Kurkimilis E, Dowzicky M, Talbot GH "Treatment of methicillin-resistant Staphylococcus aureus infections with quinupristin-dalfopristin in patients intolerant of or failing prior therapy." J Antimicrob Chemother 46 (2000): 775-84

5. Chant C, Rybak MJ "Quinupristin/dalfopristin (RP 59500): a new streptogramin antibiotic." Ann Pharmacother 29 (1995): 1022-7

6. Nichols RL, graham DR, Barriere SL, et al. "Treatment of hospitalized patients with complicated gram-positive skin and skin structure infections: two randomized, multicentre studies of quinupristin/dalfopristin versus cefazolin, oxacillin or vancomycin." J Antimicrob Chemother 44 (1999): 263-73

7. Raad I, Hachem R, Hanna H, et al. "Treatment of vancomycin-resistant enterococcal infections in the immunocompromised host: quinupristin-dalfopristin in combination with minocycline." Antimicrob Agents Chemother 45 (2001): 3202-4

8. Evans PC, Almas JP, Criddle III FJ "Anemia and reversible reticulocytopenia associated with extended quinupristin/dalfopristin." Ann Pharmacother 38 (2004): 720-1

9. Launay O, Chemlal K, Andrieu V, Carbon C "Severe reversible reticulocytopenic anemia associated with quinupristin/dalfopristin RP59500 therapy." Clin Infect Dis 25 (1997): 156

10. Cole RP, Roberts WD, Cheng MD "Hyponatremia associated with quinupristin-dalfopristin." Ann Intern Med 133 (2000): 485

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