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 Class          Common                    Uncommon                        Rare                     Not Known a Infections and                                   Genital fungal infection Pseudomembranous     colitisb   Superinfectionb infestations
Blood and lymphatic    Eosinophilia              Granulocytopenia                                         Haemolytic anaemiab system disorders       Leucopenia                Anaemia                                                  Agranulocytosis Thrombocytopenia          Coagulopathy
Immune system                                                                                             Anaphylactic shock disorders                                                                                                 Anaphylactic reaction Anaphylactoid reaction
Hypersensitivityb
Jarisch-Herxheimer reactionb
Nervous system                                   Headache Dizziness         Encephalopathy                Convulsion disorders
Ear and                                                                                                   Vertigo labyrinth disorders
Cardiac                                                                                                   Kounis syndrome disorders
Respiratory,                                                                Bronchospasm thoracic and mediastinal disorders
Gastrointestinal       Diarrhoeab Loose stools   Nausea Vomiting                                          Pancreatitisb disorders                                                                                                 Stomatitis Glossitis Hepatobiliary          Hepatic enzyme                                                                     Gall bladder precipitationb disorders              increased                                                                          Kernicterus Hepatitisc
Hepatitis cholestaticb,c
Skin and               Rash                      Pruritus                   Urticaria                     Stevens Johnson Syndromeb subcutaneous                                                                                              Toxic epidermal necrolysisb tissue disorders                                                                                          Erythema multiform Acute generalised exanthematous
Pustulosis
Drug reaction with eosinophilia and systemic symptoms (DRESS)b
Renal and                                                                   Haematuria Glycosuria         Oliguria urinary                                                                                                   Renal precipitation disorders                                                                                                 (reversible) General                                          Phlebitis Injection site   Oedema Chills disorders and                                    pain Pyrexia
administration site conditions
Investigations                           Blood creatinine                            Coombs test false positiveb increased                                   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 c
Usually reversible upon discontinuation of ceftriaxone

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 ceftriaxone precipitation in the urinary tract have been reported, mostly in children treated with high doses (e.g. ≥ 80 mg/kg/day or total doses exceeding 10 grams) and who have other risk factors (e.g. dehydration, confinement to bed). This event may be asymptomatic or symptomatic, and may lead to ureteric obstruction and postrenal acute renal failure, but is usually 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/