Unasyn

Unasyn Adverse Reactions

sultamicillin

ampicillin + sulbactam

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Film-coated tablet: Sultamicillin is generally well tolerated. The majority of side effects observed were of mild or moderate severity and were normally tolerated with continued treatment.
Infections and Infestations: Pseudomembranous colitis, Candida infection.
Blood and Lymphatic System Disorders: Thrombocytopenia.
Immune System Disorders: Anaphylactic shock, Anaphylactic reaction, Kounis syndrome, Hypersensitivity.
Nervous System Disorders: Dizziness, Somnolence, Sedation, Headache.
Respiratory, Thoracic and Mediastinal Disorders: Dyspnea.
Gastrointestinal Disorders: Enterocolitis, Melena, Diarrhea, Vomiting, Abdominal pain, Dyspepsia, Nausea, Stomatitis, Dysgeusia, Tongue discolouration.
Hepatobiliary Disorders: Jaundice, Hepatic function abnormal (see Precautions).
Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, Erythema multiforme (see Precautions), Angioedema, Urticaria, Dermatitis, Rash, Pruritus.
Musculoskeletal and Connective Tissue Disorders: Arthralgia.
General Disorders and Administration Site Conditions: Fatigue, Malaise.
Investigations: Alanine aminotransferase increased, Aspartate aminotransferase increased (see Precautions).
Adverse reactions associated with the use of ampicillin alone and/or sulbactam/ampicillin IM/IV may be observed with sultamicillin. These include: Blood and Lymphatic System Disorders: Agranulocytosis, Hemolytic anemia, Thrombocytopenic purpura, Leukopenia, Neutropenia, Eosinophilia, Anemia.
Immune System Disorders: Anaphylactoid shock, Anaphylactoid reaction.
Nervous System Disorders: Convulsion.
Gastrointestinal Disorders: Glossitis.
Hepatobiliary Disorders: Hepatitis cholestatic, Cholestasis, Hyperbilirubinaemia (see Precautions).
Skin and Subcutaneous Tissue Disorders: Exfoliative dermatitis, Acute generalized exanthematous pustulosis (see Precautions).
Renal and Urinary Disorders: Tubulointerstitial nephritis.
Investigations: Platelet aggregation abnormal.
Powder for injection: Adverse reactions associated with the use of ampicillin alone may be observed with sulbactam sodium/ampicillin sodium IM/IV.
All ADRs listed in the CDS are presented by MedDRA SOC. Within each frequency category, the ADRs are presented in the order of seriousness. Seriousness of the ADRs was determined by clinical importance. (See Table 3.)

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