Adverse reactions : תופעות לוואי

4.8        Undesirable effects
The meaning of the named frequencies is as follows: 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       Common            Uncommon                Rare          Very rare        Not known class
Infections and                                            Rhinitis                          Long-term or infestations                                                                                repeated use may lead to superinfection or colonisation with resistant bacteria      or yeasts     (oral thrush,
monoliasis vaginalis)
Blood and                        Thrombocytopenia,        Coagulation lymphatic                        neutropenia,             disorders,
system disorders                 leucopenia,              haemorrhages* eosinophilia,
agranulocytosis,
haemolytic anaemia,
granulocytosis,
leukocytosis,
monocytosis,
lymphocytopenia,
basophilia
Immune system      Allergic     Severe                                       Life disorders          skin         hypersensitivity                             threatening reactions    reactions such as                            anaphylactic such as      angioedema and                               shock ** erythema,    drug-induced fever urticaria and pruritus
Metabolism and                                           Hyperglycaemia nutrition                                                , hypoglycaemia disorders
Nervous system                                           dizziness                           convulsions § disorders
Respiratory,                                             Pleural effusion, thoracic and                                             dyspnoea or mediastinal                                              respiratory disorders                                                distress, cough Gastrointestinal   Diarrhoea,                                                                Pseudomembra disorders          nausea,                                                                   nous colitis + vomiting,
loss of appetite
Skin and           Rash         Erythema                 Toxic epidermal subcutaneous                    multiforme,              necrolysis,
tissue disorders                angioedema               Stevens-
Johnson syndrome
Hepatobiliary                   Slight, transient        Temporary           Reversible disorders                       elevation of AST,        increase in         hepatitis and ALT and alkaline         GGT, bilirubin      cholestatic phosphatase              and/or LDH          jaundice
Renal and                                                Interstitial urinary                                                  nephritis and disorders                                                other kidney diseases $
General                         Phlebitis,               Malaise, fatigue, disorders and                   thrombophlebitis         chest pain administration
site conditions


* Patients at risk for these effects are those with vitamin K deficiency or other factors leading to coagulation disturbances and patients with diseases that induce or intensify bleedings.
** which may necessitate immediate intensive care.
§ Especially in case of overdosing or unadjusted dosing in renal failure.
# In most cases, the symptoms are only mild and often disappear during or after the treatment.
+ In cases of severe and persistent diarrhoea during or after the treatment with cefazolin a physician should be consulted because this could be the symptom of a serious disease (pseudomembranous colitis) that must be treated immediately (e.g. with oral vancomycin 250 mg qid). The patients should refrain from any self medication with peristalsis-inhibiting drugs.
$ Mostly in severely ill patients receiving additional drugs.

In cases of severe and persistent diarrhoea during or after the treatment with cefazolin, a physician should be consulted because this could be the symptom of a serious disease (pseudomembranous colitis) that must be treated immediately. The patients should refrain from any self-medication with peristalsis inhibiting medicinal products (see section 4.4).
Prolonged use of a cephalosporin may result in the overgrowth of cefazolin-resistant bacteria, especially Enterobacter, Citrobacter, Pseudomonas, Enterococci, or Candida.


Studies
Transient increase in SGOT, SGPT, blood urea and alkaline phosphatase without clinical evidence of renal or hepatic damage. Animal data has shown that a potential nephrotoxicity with cefazolin exists. Although not demonstrated in humans, this possibility should nevertheless be considered especially in patients receiving high doses administered over longer periods. Interstitial nephritis and undefined nephropathies have been reported in rare cases. The patients affected were seriously ill and had several medications administered. The role of cefazolin in the development of interstitial nephritis and other nephropathies has not been established.

In rare cases the following have been reported:
Decreased haemoglobin and/or hematocrit, anaemia, aplastic anaemia, pancytopenia and haemolytic anaemia.

The following cases have been reported during treatment with certain cephalosporins: Nightmares, vertigo, hyperactivity, nervousness or anxiety, insomnia, drowsiness, weakness, hot flushes, disturbed colour vision, confusion and epileptogenic activity.


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/