Safety Profile
Common: Retching, stomach ache, injection site phlebitis, hypernatraemia and/or hypokalaemia, erythematous eruption.
For further information, please refer to the https://www.medicines.org.uk/emc/product/100356/smpc
Summary of the safety profile
The most commonly reported adverse reactions during treatment are erythematous skin eruption, ion disbalances, injection site reactions, dysgeusia and gastrointestinal disturbances. Other important adverse reactions include anaphylactic shock, antibiotic associated colitis and decreases in white blood cell counts.
Tabulated list of adverse reactions
Undesirable effects are listed by body system and frequency using the following convention:
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
Not known: cannot be estimated from the available data
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
| System Organ Class | Frequency | Adverse reaction |
|---|---|---|
| Blood and lymphatic system disorders | Not known | Agranulocytosis (transient), leucopenia, thrombocytopenia, neutropenia |
| Immune system disorders | Very rare | Anaphylactic reactions including anaphylactic shock and hypersensitivity |
| Nervous system disorders | Common | Dysgeusia |
| Uncommon | Headache | |
| Investigations | Common | Hypernatremia, hypokalemia* |
| Gastrointestinal disorders | Uncommon | Nausea, vomiting, diarrhea |
| Not known | Antibiotic-associated colitis | |
| Hepatobiliary disorders | Uncommon | Blood alkaline phosphatase increased (transient), Transaminases increased (ALAT, ASAT), gamma-GT increased |
| Not known | Hepatitis | |
| Skin and subcutaneous tissue disorders | Common | Erythematous eruption |
| Uncommon | Rash | |
| Not known | Angioedema, pruritus, urticaria | |
| General disorders and administration site conditions | Common | Injection site phlebitis |
| Uncommon | Asthenia |
Description of selected adverse reactions:
Hypokalemia may result in diffuse symptoms such as weakness, tiredness or oedema and/or muscle twitching. Severe forms may cause hyporeflexia and cardiac arrhythmia. Hypernatremia may be associated with thirst, hypertension and signs of fluid overload such as oedema.
Severe forms may cause confusion, hyperreflexia, seizures and coma.
Paediatric population
Limited safety information is available from the paediatric population. Frequency, type and severity of adverse reactions may be expected to be similar to the adult population.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions (please follow the ‘Adverse Event Reporting’ link that can be found at the top of the page).
