Applies to chloramphenicol: powder for solution.
Warning
Intravenous route (Powder for Solution)
Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. It is essential that adequate blood studies be made during treatment with the drug.
Intravenous route (Powder for Solution)
Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. It is essential that adequate blood studies be made during treatment with the drug.
Serious side effects of Chloramphenicol
Along with its needed effects, chloramphenicol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Stop taking chloramphenicol and get emergency help immediately if any of the following effects occur:
Rare
- in babies only- Bloated stomach
- drowsiness
- gray skin color
- low body temperature
- uneven breathing
- unresponsiveness
Check with your doctor immediately if any of the following side effects occur while taking chloramphenicol:
Less common
- Pale skin
- sore throat and fever
- unusual bleeding or bruising
- unusual tiredness or weakness (the above side effects may also occur up to weeks or months after you Stop taking chloramphenicol)
Rare
- Confusion, delirium, or headache
- eye pain, blurred vision, or loss of vision
- numbness, tingling, burning pain, or weakness in the hands or feet
- skin rash, fever, or difficulty in breathing
Other side effects of Chloramphenicol
Some side effects of chloramphenicol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Diarrhea
- nausea or vomiting
For Healthcare Professionals
Applies to chloramphenicol: compounding powder, injectable powder for injection, oral capsule.
Hematologic
Very rare (less than 0.01%): Aplastic anemia
Frequency not reported: Drug-induced bone marrow depression, blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, granulocytopenia), reversible dose-related bone marrow depression (characterized by vacuolization of erythroid cells, reduction of reticulocytes, leukopenia), agranulocytosis, bone marrow failure, pancytopenia, thrombocytopenic purpura, increased bleeding time, aplastic anemia resulting in leukemia, paroxysmal nocturnal hemoglobinuria, hemolysis[Ref]
Hypersensitivity
Frequency not reported: Hypersensitivity reactions (including fever, macular and vesicular rashes, angioedema, urticaria, anaphylaxis), allergic skin reactions, hypersensitivity myocarditis[Ref]
Dermatologic
Frequency not reported: Angioedema, macular and vesicular rashes, urticaria, contact dermatitis
Gastrointestinal
Frequency not reported: Nausea, vomiting, glossitis, stomatitis, diarrhea, enterocolitis, dry mouth, antibiotic-associated pseudomembranous colitis, Clostridioides difficile-associated diarrhea[Ref]
Nervous system
Frequency not reported: Headache, peripheral neuritis, encephalopathy, ototoxicity, sensorineural hearing loss[Ref]
Psychiatric
Frequency not reported: Mild depression, mental confusion, delirium
Ocular
Frequency not reported: Optic neuritis, transient blindness, blurred vision, optic neuritis leading to blindness
Cardiovascular
Grey syndrome has been reported in neonates, premature infants, and infants; in most cases, therapy with this drug was started within the first 48 hours of life. Symptoms first appeared after 3 to 4 days of continued therapy with high doses and appeared in the following order: abdominal distension (with or without emesis), progressive pallid cyanosis, vasomotor collapse (often with irregular respiration), death within a few hours after onset of symptoms. In at least 1 case, grey syndrome was reported in a neonate whose mother had received this drug during labor. High serum drug levels (greater than 90 mcg/mL) have been associated with grey syndrome and large doses have been associated with a rapidly fatal course. Symptoms were often reversible with complete recovery when this drug was discontinued immediately.[Ref]
Frequency not reported: Cardiomyopathy, grey syndrome, acidotic cardiovascular collapse[Ref]
Other
Frequency not reported: Fever, fungal superinfection[Ref]
Immunologic
Herxheimer reactions have been reported during treatment of typhoid fever.
Frequency not reported: Herxheimer reactions
Hepatic
Frequency not reported: Hepatitis[Ref]
