pharmacopeia
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/api/v1/drug/chloramphenicol

Boxed warning

Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia and granulocytopenia) are known to occur after the administration of chloramphenicol. In addition, 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. Chloramphenicol must not be used when less potentially dangerous agents will be effective, as described in the INDICATIONS AND USAGE section. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections. Precautions: It is essential that adequate blood studies be made during treatment with the drug. While blood studies may detect early peripheral blood changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such studies cannot be relied on to detect bone marrow depression prior to development of aplastic anemia. To facilitate appropriate studies and observation during therapy, it is desirable that patients be hospitalized.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Protein Synthesis Inhibitors.

Protein Synthesis

Contraindications

Sourced from openFDA
  • Chloramphenicol is contraindicated in individuals with a history of previous hypersensitivity and/or toxic reaction to it. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections.contraindicated

Adverse reactions

Sourced from openFDA

Blood Dyscrasias The most serious adverse effect of chloramphenicol is bone marrow depression. Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. An irreversible type of marrow depression leading to aplastic anemia with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplasia or hypoplasia. Peripherally, pancytopenia is most often observed, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed. A reversible type of bone marrow depression, which is dose related, may occur. This type of marrow depression is characterized by vacuolization of the erythroid cells, reduction of reticulocytes and leukopenia, and responds promptly to the withdrawal of chloramphenicol. An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding 1) the size of the population at risk, 2) the total number of drug-associated dyscrasias, and 3) the total number of non-drug associated dyscrasias. In a report to the California State Assembly by the California Medical Association and the State Department of Public Health in January 1967, the risk of fatal aplastic anemia was estimated at 1:24,200 to 1:40,500 based on two dosage levels. There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia.

Use in specific populations

Sourced from openFDA

Pregnancy Pregnancy Category C – Animal reproduction studies have not been conducted with chloramphenicol. There are no adequate and well-controlled studies to establish safety of this drug in pregnancy. It is not known whether chloramphenicol can cause fetal harm when administered to a pregnant woman. Orally administered chloramphenicol has been shown to cross the placental barrier. Because of potential toxic effects on the fetus (see ADVERSE REACTIONS, “Gray Syndrome” ), chloramphenicol should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Approval history

Sourced from openFDA
  • Aug 25, 1982ANDAANDA062365Fresenius Kabi Usa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
28 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Grey Syndrome Neonatal414%
  2. 2Headache311%
  3. 3Lethargy311%
  4. 4Metabolic Acidosis311%
  5. 5Alanine Aminotransferase Increased27.1%
  6. 6Apnoea27.1%
  7. 7Condition Aggravated27.1%
  8. 8Drug Level Increased27.1%
  9. 9Fatigue27.1%
  10. 10Hypotension27.1%
  11. 11Intraocular Pressure Increased27.1%
  12. 12Malaise27.1%
  13. 13Overdose27.1%
  14. 14Pyrexia27.1%
  15. 15Visual Impairment27.1%

Literature

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Recent PubMed references pinned to Chloramphenicol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Chloramphenicol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Chloramphenicol. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • G6PDCPIC CClinPGx 3
    G6PD

Frequently asked questions

How does Chloramphenicol work?
Mechanism-of-action class: Protein Synthesis Inhibitors.
What class of drug is Chloramphenicol?
Chloramphenicol is classified as Amphenicols, Antibiotics, Antiinfectives, Antiinfectives for treatment of acne, Other antibiotics for topical use, Amphenicol-class Antibacterial, Protein Synthesis Inhibitors, Decreased Protein Synthesis.
What are the brand names for Chloramphenicol?
Chloramphenicol is marketed under brand names including Viceton.
What are the contraindications for Chloramphenicol?
Chloramphenicol labeling lists contraindications including: Chloramphenicol is contraindicated in individuals with a history of previous hypersensitivity and/or toxic reaction to it. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections.. Always consult the full prescribing information and a clinician.
Note. Data for chloramphenicol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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