Adverse reactions : תופעות לוואי

4.8. Undesirable effects
Summary of the Safety profile
The most common adverse reactions are phlebitis, pseudo-allergic reactions and flushing of the upper body (“red-neck syndrome”) in connection with too rapid intravenous infusion of vancomycin.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with vancomycin treatment (see section 4.4).
The absorption of vancomycin from the gastrointestinal tract is negligible. However, in severe inflammation of the intestinal mucosa, especially in combination with renal insufficiency, adverse reactions that occur when vancomycin is administered parenterally may appear.

Tabulated List of Adverse reactions
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The adverse reactions listed below are defined using the following MedDRA convention and system organ class database:
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).


System Organ Class                                   Frequency grouping + Adverse reaction Blood and the lymphatic system disorders             Rare
- Reversible neutropenia (1)
- agranulocytosis
- eosinophilia
- thrombocytopenia
- pancytopenia

Immune system disorders                              Rare
- hypersensitivity reactions.
- anaphylactic reactions (2)
Ear and labyrinth disorders                          Uncommon
- transient or permanent loss of hearing (4)
Rare
- Vertigo,
- tinnitus (3) ,
- dizziness.
Cardiac disorders                                    Very Rare
- cardiac arrest.
Vascular disorders                                   Common
- decrease in blood pressure,
Rare
- vasculitis.
Respiratory, thoracic and mediastinal                Common disorders                                            - dyspnea,
- stridor.
Gastrointestinal disorders                           Rare
- nausea
Very Rare
- pseudomembranous enterocolitis
Not known
Vomiting, Diarrhoea
Skin and subcutaneous tissue disorders             Common
Flushing of the upper body (“red man syndrome”)
- exanthema and mucosal inflammation,
- pruritus,
- urticaria.
Very Rare
- exfoliative dermatitis,
- Stevens-Johnson syndrome,
- Toxic epidermal necrolysis (TEN),
- Linear IgA bullous dermatosis
Not known
- Eosinophilia and systemic symptoms
(DRESS syndrome (drug-induced hypersensitivity syndrome))
- AGEP (Acute Generalized
Exanthematous Pustulosis)
Renal and urinary disorders                        Common
- renal insufficiency manifested primarily by increased serum creatinine and serum urea
Rare
- interstitial nephritis,
- acute renal failure.
Not known
- Acute tubular necrosis
General disorders and administration site          Common conditions                                         - Phlebitis
- redness of the upper body and face,
Rare
- drug fever,
- shivering.
- pain and muscle spasm of the chest and back muscles
Very Rare necrosis and pain at injection site

Description of selected adverse drug reactions
(1)Reversible neutropenia usually starting one week or more after onset of intravenous therapy or after total dose of more than 25 g.
(2 )During or shortly after rapid infusion anaphylactic/anaphylactoid reactions including wheezing may occur. The reactions abate when administration is stopped, generally between 20 minutes and 2 hours. Vancomycin should be infused slowly (see sections 4.2 and 4.4). Necrosis may occur after intramuscular injection.
(3) Tinnitus, possibly preceding onset of deafness, should be regarded as an indication to discontinue treatment.
(4) Ototoxicity has primarily been reported in patients given high doses, or in those on concomitant treatment with other ototoxic medicinal product like aminoglycoside, or in those who had a pre-existing reduction in kidney function or hearing.

Paediatric population

The safety profile is generally consistent among children and adult patients.
Nephrotoxicity has been described in children, usually in association with other nephrotoxic agents such as aminoglycosides.

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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/