Ampicillin / sulbactam Side Effects

Some side effects of ampicillin / sulbactam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ampicillin / sulbactam: injectable powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking ampicillin / sulbactam: 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:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• diarrhea that is watery or bloody; or

• fever, chills, body aches, flu symptoms.

Less serious side effects of ampicillin / sulbactam may include:

• nausea, vomiting, stomach pain, bloating, gas;

• vaginal itching or discharge;

• headache;

• itching;

• swollen, black, or "hairy" tongue;

• thrush (white patches or inside your mouth or throat); or

• pain, swelling, or other irritation where the needle is placed.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to ampicillin / sulbactam: injectable powder for injection

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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