Fortum Adverse Reactions

Data from large clinical trials (internal and published) were used to determine the frequency of very common to uncommon undesirable effects. The frequencies assigned to all other undesirable effects were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.
The following convention has been used for the classification of frequency: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1,000 to <1/100, rare ≥1/10,000 to <1/1,000, very rare <1/10,000.
Infections and infestations: Uncommon: Candidiasis (including vaginitis and oral thrush).
Blood and lymphatic system disorders: Common: Eosinophilia and thrombocytosis; Uncommon: Leucopenia, neutropenia, and thrombocytopenia; Very rare: Lymphocytosis, haemolytic anaemia, and agranulocytosis.
Immune system disorders: Very rare: Anaphylaxis (including bronchospasm and/or hypotension).
Nervous system disorders: Uncommon: Headache and dizziness; Very rare: Paraesthesia.
There have been reports of neurological sequelae including tremor, myoclonia, convulsions, encephalopathy, and coma in patients with renal impairment in whom the dose of Ceftazidime (Fortum) has not been appropriately reduced.
Vascular disorders: Common: Phlebitis or thrombophlebitis with i.v. administration.
Gastrointestinal disorders: Common: Diarrhoea; Uncommon: Nausea, vomiting, abdominal pain, and colitis; Very rare: Bad taste.
As with other cephalosporins, colitis may be associated with Clostridium difficile and may present as pseudomembranous colitis (see Precautions).
Hepatobiliary disorders: Common: Transient elevations in one or more of the hepatic enzymes, ALT (SGPT), AST (SOGT), LDH, GG and alkaline phosphatase; Very rare: Jaundice.
Skin and subcutaneous tissue disorders: Common: Maculopapular or urticarial rash; Uncommon: Pruritus; Very rare: Angioedema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
General disorders and administration site conditions: Common: Pain and/or inflammation after i.m. injection; Uncommon: Fever.
Investigations: Common: Positive Coombs test; Uncommon: As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen and/or serum creatinine have been observed.
A positive Coombs test develops in about 5% of patients and may interfere with blood cross-matching.