Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased.
Data to determine the frequency of ceftriaxone ADRs was derived from clinical trials.

The following convention has been used for the classification of frequency: − Very common (≥ 1/10);
− Common (≥ 1/100 - < 1/10);
− Uncommon (≥ 1/1000 - < 1/100);
− Rare (≥ 1/10000 - < 1/1000);
− Not known (cannot be estimated from the available data);

System Organ        Common           Uncommon            Rare              Not Known a Class

Infections and                       Genital             Pseudomembranous Superinfectionb infestations                         fungal              colitisb infection
Blood and        Eosinophilia     Granulocytopenia                         Haemolytic lymphatic system disorders
Leucopenia       Anaemia                                  anaemiab
Thrombocytopenia Coagulopathy                             Agranulocytosis 
Immune system                                                              Anaphylactic shock disorders
Anaphylactic reaction
Anaphylactoid reaction
Hypersensitivityb

Nervous system                       Headache                              Convulsion disorders
Dizziness

Ear and labyrinth                                                          Vertigo disorders

Respiratory,                                             Bronchospasm thoracic and mediastinal disorders
Gastrointestinal    Diarrhoeab       Nausea                                Pancreatitisb disorders
Loose stools     Vomiting                              Stomatitis
Glossitis

Hepatobiliary       Hepatic enzyme                                         Gall bladder disorders           increased                                              precipitationb Kernicterus
Skin and            Rash             Pruritus            Urticaria         Stevens subcutaneous                                                               Johnson tissue disorders                                                           Syndromeb Toxic epidermal necrolysisb
Erythema multiforme
Acute generalised exanthematous
Pustulosis

System Organ        Common               Uncommon              Rare                  Not Known a Class

Renal and                                                      Haematuria            Oliguria urinary disorders
Glycosuria            Renal precipitation
(reversible)

General                                  Phlebitis             Oedema disorders and administration                           Injection site pain   Chills site conditions                          Pyrexia
Investigations                           Blood creatinine                            Coombs test false increased                                   positiveb
Galactosaemia test false positiveb
Non enzymatic methods for glucose determination false positiveb

 a Based on post-marketing reports. Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency, which is therefore categorised as not known.
b See section 4.4


Infections and infestations
Reports of diarrhoea following the use of ceftriaxone may be associated with Clostridium difficile. Appropriate fluid and electrolyte management should be instituted (see section 4.4).


Ceftriaxone-calcium salt precipitation
Rarely, severe, and in some cases, fatal, adverse reactions have been reported in pre-term and full-term neonates (aged < 28 days) who had been treated with intravenous ceftriaxone and calcium.


Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem. The high risk of precipitation in neonates is a result of their low blood volume and the longer half-life of ceftriaxone compared with adults (see sections 4.3, 4.4, and 5.2).

Cases of renal precipitation have been reported, primarily in children older than 3 years of age and who have been treated with either high daily doses (e.g. ≥ 80 mg/kg/day) or total doses exceeding 10 grams and who presented with other risk factors (e.g. fluid restrictions or confinement to bed). The risk of precipitate formation is increased in immobilized or dehydrated patients. This event may be symptomatic or asymptomatic, may lead to renal insufficiency and anuria, and is reversible upon discontinuation of ceftriaxone (see section 4.4).


Precipitation of ceftriaxone calcium salt in the gallbladder has been observed, primarily in patients treated with doses higher than the recommended standard dose. In children, prospective studies have shown a variable incidence of precipitation with intravenous application - above 30 % in some studies. The incidence appears to be lower with slow infusion (20 - 30 minutes). This effect is usually asymptomatic, but the precipitations have been accompanied by clinical symptoms such as pain, nausea and vomiting in rare cases. Symptomatic treatment is recommended in these cases. Precipitation is usually reversible upon discontinuation of ceftriaxone (see section 4.4).

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/