Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The following are the undesirable effects of chloramphenicol categorised according to the MedDRA system organ class. Insufficient data are available to establish the frequency of the individual effects listed.
Disorders of the blood and lymphatic system
Bone marrow depression: it may occur in two different forms: the first, dose-dependent form is characterised by agranulocytosis, anemia, leukopenia, thrombocytopenia and reticulocytopenia; the second form that is not dose- related, is a very severe form of aplastic anemia that develops after a latent period of weeks or even months.
Depression of erythropoiesis is more frequent in patients with hepatic or renal insufficiency.


Traumatism, poisoning and procedural complications
“Gray baby syndrome”: this toxic manifestation has been observed in newborns who have been given high doses of chloramphenicol. It is characterised by abdominal distension, vomiting, ashy skin, hypothermia, progressive cyanosis, circulatory collapse, and death within hours or days. It appears that the cause may be the lack of glucuronide conjugation of chloramphenicol, due to inadequate hepatic glucuronyltransferase activity during the first weeks of neonatal life, and inadequate renal excretion of the unconjugated drug.


Gastrointestinal disorders
Nausea, vomiting, unpleasant taste sensation (dysgeusia), diarrhea, stomatitis, glossitis, enterocolitis, perineal irritation.


Disorders of the immune system
Hypersensitivity reactions with the onset of fever, rash, anaphylaxis.

Nervous system disorders
Optic or peripheral neuritis, ototoxicity, headache, mental confusion.

Infections and infestations
Jarisch-Herxheimer reaction, characterised by chills, headache, fever and mucocutaneous lesions.


Psychiatric disorders
Mild depression and delirium

Respiratory, thoracic and mediastinal disorders
Bronchospasm

Hepatobiliary disorders
Hepatotoxicity


Reporting of side effects
Reporting of suspected adverse reactions after the authorization of the medicinal product is important, as it allows continuous 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