Unasyn Side Effects

Please note - some side effects for Unasyn 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 of Unasyn - for the Consumer

Unasyn

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 Unasyn:

Mild diarrhea; pain, swelling, or redness at injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools or severe diarrhea; chest pain; chills; fever; severe nausea or vomiting; stomach pain or cramps; unusual bruising or bleeding; vaginal irritation or discharge; vein inflammation or tenderness; white patches in mouth.

Unasyn Side Effects - for the Professional

Unasyn

Adult Patients

Unasyn is generally well tolerated. The following adverse reactions have been reported.

Pain at IM injection site – 16%

Pain at IV injection site – 3%

Thrombophlebitis – 3%

The most frequently reported adverse reactions were diarrhea in 3% of the patients and rash in less than 2% of the patients.

Additional systemic reactions reported in less than 1% of the patients were: itching, nausea, vomiting, candidiasis, fatigue, malaise, headache, chest pain, flatulence, abdominal distension, glossitis, urine retention, dysuria, edema, facial swelling, erythema, chills, tightness in throat, substernal pain, epistaxis and mucosal bleeding.

Pediatric Patients

Available safety data for pediatric patients treated with Unasyn demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving Unasyn.

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:

Hepatic: Increased AST (SGOT), ALT (SGPT), alkaline phosphatase, and LDH.

Hematologic: Decreased hemoglobin, hematocrit, RBC, WBC, neutrophils, lymphocytes, platelets and increased lymphocytes, monocytes, basophils, eosinophils, and platelets.

Blood Chemistry: Decreased serum albumin and total proteins.

Renal: Increased BUN and creatinine.

Urinalysis: Presence of RBC's and hyaline casts in urine.

The following adverse reactions have been reported with ampicillin-class antibiotics and can also occur with Unasyn.

Gastritis, stomatitis, black "hairy" tongue and enterocolitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.

Urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with a penicillin.

In addition to the adverse laboratory changes listed above for Unasyn, agranulocytosis has been reported during therapy with penicillins. All of these reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Some individuals have developed positive direct Coombs Tests during treatment with Unasyn, as with other beta-lactam antibiotics.

Side Effects by Body System

General

Ampicillin-sulbactam is generally well-tolerated.

Local

Local side effects have included pain at the intramuscular injection site (16%), pain at the intravenous injection site (3%), and thrombophlebitis (3%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (3%), nausea (<1%), vomiting (<1%), flatulence (<1%), abdominal distension (<1%), and glossitis (<1%). Rare cases of pancreatitis have been reported. Ampicillin-class antibiotics have been associated with gastritis, stomatitis, black hairy tongue, enterocolitis, and pseudomembranous colitis.

Hypersensitivity

Hypersensitivity reactions to ampicillin have included urticarial rash, edema, hypotension, fever, eosinophilia, dyspnea, a delayed hypersensitivity maculopapular rash, anaphylaxis, interstitial nephritis, Henoch-Schonlein purpura, focal glomerulonephritis, and Stevens-Johnson syndrome.

Dermatologic

Dermatologic side effects have included rash (<2%), itching (<1%), erythema multiforme, and exfoliative dermatitis. Rare cases of ampicillin-associated bullous pemphigoid, linear IgA dermatosis, and pseudoporphyria have been reported.

Hematologic

Hematologic side effects have included decreases in hemoglobin, hematocrit, red blood cells, neutrophils, lymphocytes, and platelets, and increases in lymphocytes, monocytes, basophils, eosinophils, and platelets. Thrombocytopenia, leukopenia, red cell aplasia, anemia, and positive direct Coombs test have rarely been reported. Atypical lymphocytosis has been reported in a pediatric patient. Penicillins have been associated with agranulocytosis.

Nervous system

Nervous system side effects have included seizures in very ill patients with high serum concentrations of ampicillin. High cerebral spinal fluid (CSF) levels of some penicillins are known to be potentially neurotoxic, and the CSF concentrations of ampicillin rise significantly in meningitis. Ampicillin may worsen myasthenia gravis symptoms.

Hepatic

Hepatic side effects have included increases in AST (SGOT), ALT (SGPT), alkaline phosphatase, and LDH. Rare cases of hepatitis and prolonged cholestasis have been reported.

Metabolic

Metabolic side effects have included decreases in serum albumin and total protein.

Genitourinary

Genitourinary side effects have included urine retention, dysuria, urinary red blood cells, and urinary hyaline casts. Superinfections may occur (i.e., Candida, Pseudomonas).

Renal

Renal side effects have included increases in BUN and creatinine.

Other

Other side effects have included facial swelling, erythema, chills, throat tightness, substernal pain, epistaxis, and mucosal bleeding.

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