Sultamicillin is generally well-tolerated. Most adverse effects (AEs) are mild to moderate in severity and are normally tolerated with continued treatment.
Body as a Whole:
Fatigue/malaise and headache have been rarely observed.
Rash, itching, pemphigus vulgaris, angioedema, dermatitis, urticaria; allergic reaction, anaphylaxis/anaphylactic shock, anaphylactoid reaction, superinfections, adult respiratory distress syndrome.
Vomiting, nausea, diarrhea, loose stools, epigastric distress, melena, abdominal pain/cramps.
Taste disturbances, ototoxicity, dizziness, drowsiness/sedation.
Kidney function disorder.
The following AEs have also been reported for aminopenicillin-class antibiotics including ampicillin and/or parenteral ampicillin/sulbactam: Dermatologic/Hypersensitivity reactions:
Pruritus, dry skin, erythema; rare reports of exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson syndrome; serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever); systemic allergic reactions (characterized by neck tightness, difficulty and pain when breathing, generalized weakness, and hypertension); facial swelling; positive direct antiglobulin (Coombs' test).
Anorexia, gastritis, black hairy tongue, glossitis, stomatitis, CDAD and colitis; acute, transient enterocolitis with severe abdominal pain and bloody diarrhea, but without evidence of CDAD and colitis; acute pancreatitis; flatulence, abdominal discomfort or distension, rectal bleeding.
Headache, confusion; rare reports of convulsions/myoclonic seizures; generalized seizures.
Anemia, hemolytic anemia, hypothrombinemia, eosinophilia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, thrombocytopenic purpura, abnormal platelet aggregation, prolongation of bleeding time, and prolongation of activated partial thromboplastin time (APTT); decreased hemoglobin concentration, hematocrit, erythrocyte, lymphocyte, and platelet counts; increased lymphocyte, monocyte, basophil, eosinophil, and platelet counts.
Transient elevations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, lactate dehydrogenase (LDH), creatine kinase (CK), bilirubin, and γ-glutamyltransferase (γ-glutamyltranspeptidase, GT, GGTP); bilirubinemia, abnormal hepatic function, and jaundice.
Rare reports of acute interstitial nephritis; glomerulonephritis; increased blood urea nitrogen (BUN) and serum creatinine concentrations; presence of red blood cells and hyaline casts in urine, urine retention, dysuria, hematuria, crystalluria.
Other Adverse Effects:
Decreased concentrations of serum albumin and total protein; chest pain or tightness, edema, chills, throat tightness, substernal pain, epistaxis, mucosal bleeding; changes in smell perception.