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              Encephalopathy    Convulsion disorders                                    Dizziness
Ear and labyrinth                                                                    Vertigo disorders
Respiratory, thoracic and                                          Bronchospasm mediastinal disorders
Gastrointestinal            Diarrhoeab       Nausea                                  Pancreatitisb disorders                   Loose stools     Vomiting                                Stomatitis Glossitis
Hepatobiliary disorders     Hepatic enzyme                                           Gall bladder precipitationb increased                                                Kernicterus
Hepatitis c
Hepatitis cholestaticb,c
Skin and subcutaneous       Rash             Pruritus              Urticaria         Stevens Johnson Syndromeb tissue disorders                                                                     Toxic epidermal necrolysisb Erythema multiform
Acute generalised exanthematous
Pustulosis
Drug reaction with eosinophilia and systemic symptoms
(DRESS)b
Renal and urinary                                                  Haematuria        Oliguria disorders                                                          Glycosuria        Renal precipitation (reversible)
General disorders and                        Phlebitis             Oedema administration site                          Injection site pain   Chills conditions                                   Pyrexia
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

Description of selected adverse reactions

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/