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 Knowna Infections and                                  Genital fungal         Pseudo-              Superinfectionb infestations                                    infection              membranous colitisb
Blood and lymphatic      Eosinophilia           Granulocytopenia                            Haemolytic anaemiab Leucopenia             Anaemia
System disorders         Thrombocytopenia       Coagulopathy                                Agranulocytosis Immune system                                                                               Anaphylactic shock disorders                                                                                   Anaphylactic reaction Anaphylactoid reaction
Hypersensitivityb
Jarisch- Herxheimer reactionb
Nervous system                                  Headache Dizziness Encephalopathy           Convulsion disorders
Ear and labyrinth                                                                           Vertigo disorders
Respiratory, thoracic                                                  Bronchospasm and mediastinal disorders
Gastrointestinal         Diarrhoeab             Nausea                                      PancreatitisbStomatitis Glossitis disorders                Loose stools           Vomiting
Hepatobiliary            Hepatic enzyme                                                     Gall bladder precipitationbKernicterus disorders                increased                                                          Hepatitisc Hepatitis cholestaticb,c
Skin and                 Rash                   Pruritus               Urticaria            Stevens Johnson SyndromebToxic subcutaneous tissue                                                                         epidermal necrolysisbErythema disorders                                                                                   multiforme Acute generalised exanthematous
Pustulosis
Drug reaction with eosinophilia and systemic symptoms (DRESS)b
Renal and urinary                                                      Haematuria           Oliguria Renal precipitation (reversible) disorders                                                              Glycosuria General disorders and                           Phlebitis Injection    Oedema Chills administration site                             site pain Pyrexia conditions
System Organ            Common Uncommon                      Rare           Not Known a Class
Investigations                    Blood creatinine           Oedema         Coombs test false positivebGalactosaemia test false increased                  Chills         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 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 side effects
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