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Chloramphenicol

AEMPS

Amphenicol antibiotic for systemic use

ATC code: J01BA01

Brand names: Chloramphenicol Sodium Succinate

Updated · Methodology

Indications

B

Typhoid fever

Third line

Chloramphenicol was the first antibiotic that cured typhoid fever, and the label still keeps acute Salmonella Typhi infection as the opening line of its indications. In Europe today typhoid is treated with ceftriaxone or azithromycin: they act faster and put no threat on the marrow. Chloramphenicol remains an option for regions where strains resistant to fluoroquinolones and cephalosporins circulate and nothing else is at hand. The same label states that in typhoid, therapeutic levels are maintained for 8 to 10 days after the patient becomes afebrile, to lessen the chance of relapse. The S. Typhi carrier state is not treated with chloramphenicol. Spain has no systemic chloramphenicol: CIMA lists only an eye ointment and a cutaneous form.

Sources

  1. FDA: Chloramphenicol Sodium Succinate for Injection, prescribing information (2024)
  2. AEMPS: Ficha técnica Oftalmolosa Cusi Cloramfenicol 10 mg/g pomada oftálmica (2026)

ICD-10: A01.0

C

Acute bacterial meningitis

Third line

The label names meningeal infections caused by Haemophilus influenzae and gram-negative meningitis among the indications for systemic chloramphenicol. The reason is historical and pharmacological: the drug enters cerebrospinal fluid without meningeal inflammation, and before third-generation cephalosporins it filled that niche. Today first-line therapy is different, and chloramphenicol stays as a fallback for severe beta-lactam allergy or where ceftriaxone is unavailable. The constraint is hard: the same label carries a boxed warning about fatal blood dyscrasias, so a full blood count goes every two days through the course, and the course itself stays as short as the illness allows. In the first weeks of life the drug is given only with blood level monitoring, because it accumulates.

Sources

  1. FDA: Chloramphenicol Sodium Succinate for Injection, prescribing information (2024)

ICD-10: G00

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Acute infectious diarrhea

Not recommended

Chloramphenicol tablets, sold as levomycetin in Russian-speaking pharmacies, are bought for diarrhoea, often without a prescription and on a neighbour's advice. Acute infectious diarrhoea in an adult mostly settles on its own within a few days, and the treatment is water with salts rather than an antibiotic. The boxed warning is blunt: chloramphenicol must not be used for trivial infections or as prophylaxis, because fatal blood dyscrasias have followed short courses too. Chloramphenicol-induced aplastic anaemia bears no relation to dose and appears weeks or months later, when the link to the tablets is no longer obvious. In salmonella gastroenteritis an antibiotic also prolongs shedding of the organism in stool. If chloramphenicol has been suggested for diarrhoea, consider seeking a second opinion from another doctor.

Sources

  1. FDA: Chloramphenicol Sodium Succinate for Injection, prescribing information (2024)
  2. AEMPS: Ficha técnica Oftalmolosa Cusi Cloramfenicol 10 mg/g pomada oftálmica (2026)

ICD-10: A09 · ICD-11: 1A40

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Chloramphenicol settles on the 50S bacterial ribosomal subunit and blocks peptidyl transferase, so amino acids stop being stitched into a chain. The action is bacteriostatic and the spectrum broad: salmonellae, Haemophilus influenzae, rickettsiae, the lymphogranuloma-psittacosis group, anaerobes. The molecule is small and lipid-soluble, so it enters cerebrospinal fluid even without meningeal inflammation, at about half the blood concentration – a figure the label states outright. The liver disposes of it by glucuronide conjugation. In newborns that pathway is not yet running, the drug accumulates and produces the gray syndrome. Marrow toxicity follows two separate routes: dose-dependent reversible suppression, and idiosyncratic aplastic anaemia unrelated to dose.

Safety

Boxed warning

FDA boxed warning: chloramphenicol causes serious and fatal blood dyscrasias – aplastic and hypoplastic anaemia, thrombocytopenia, granulocytopenia. Cases of aplastic anaemia later terminating in leukaemia have been reported. Dyscrasias have followed both short and prolonged courses. The drug is not used where less dangerous agents work, in trivial infections, or as prophylaxis. Repeated blood counts are required during treatment.

Contraindications

  • History of hypersensitivity or toxic reaction to chloramphenicol
  • Trivial infections: colds, influenza, throat infections
  • Prophylactic use to prevent bacterial infection
  • Any situation where a less dangerous antibiotic is effective

Serious adverse effects

  • Irreversible aplastic anaemia with high mortality, sometimes weeks or months after the course
  • Gray syndrome in neonates: abdominal distension, pallid cyanosis, vasomotor collapse
  • Optic and peripheral neuritis with prolonged treatment
  • Anaphylaxis and angioedema
  • Jarisch-Herxheimer reaction during treatment of typhoid fever

Common adverse effects

  • Nausea, vomiting, diarrhoea
  • Glossitis and stomatitis
  • Headache
  • Dose-related reversible marrow suppression with leukopenia and reticulocytopenia

Pregnancy: can you take Chloramphenicol?

A systemic form of chloramphenicol (tablets, injection) is not available in Spain: CIMA lists only eye and skin ointments. According to the FDA label for chloramphenicol sodium succinate injection (Fresenius Kabi, revised October 2016), no animal reproduction studies or adequate, well-controlled studies in pregnant women have been done, and it is not known whether the drug can harm the fetus. Chloramphenicol crosses the placenta, with somewhat lower concentrations in cord blood than in maternal blood. It should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. One case of gray syndrome has been reported in a newborn whose mother received chloramphenicol during labor.

Breastfeeding: can you take Chloramphenicol?

Chloramphenicol passes into breast milk. Because of serious reactions in the infant, the FDA label puts the choice plainly: either feeding stops or the drug does, weighing how much the mother needs it. That decision is made with the doctor before the course starts, not after the first dose.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions15 mentions

Verbatim lines from the interaction sections, in the language of the label

From other drugs’ labels

  • MajorClozapine
    «Comentarios: Supresores de la médula ósea (p.ej., carbamazepina, cloranfenicol, sulfonamidas (p.ej., cotrimoxazol), analgésicos pirazolónicos (p.ej., fenilbutazona), penicilamina, agentes citotóxicos…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorMethotrexate
    «Medicamentos que producen reacciones adversas en la médula ósea: En el caso de los tratamientos con medicamentos que pueden producir reacciones adversas en la médula ósea (p. ej., sulfonamidas…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorTacrolimus
    «Effects of Other Drugs on Tacrolimus: Strong CYP3A Inhibitors 3 : Protease inhibitors (e.g, nelfinavir, telaprevir, boceprevir, ritonavir), azole antifungals (e.g., voriconazole, posaconazole…»

    FDA, section 7 · Open on DailyMed

  • ModerateGlimepiride
    «Drugs Affecting Glucose Metabolism: A number of medications affect glucose metabolism and may require glimepiride dose adjustment and particularly close monitoring for hypoglycemia or worsening…»

    FDA, section 7 · Open on DailyMed

  • ModeratePirfenidone
    «Fluvoxamina e inhibidores del CYP1A2: Se recomienda especial precaución cuando se administren inhibidores de CYP1A2 conjuntamente con inhibidores potentes de una o más de las otras isoenzimas CYP que…»

    AEMPS, section 4.5 · Open on CIMA

  • Amoxicillin
    «Other Antibacterials: Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro ; however, the…»

    FDA, section 7 · Open on DailyMed

  • Ceftriaxone
    «En un estudio in vitro , se han observado efectos antagonistas tras la combinación de cloranfenicol y ceftriaxona. Se desconoce la repercusión clínica.»

    AEMPS, section 4.5 · Open on CIMA

  • Cyanocobalamin
    «Cloranfenicol: puede retrasar, interrumpir o atenuar la respuesta de la vitamina B12 sobre la eritropoyesis.»

    AEMPS, section 4.5 · Open on CIMA

  • Glimepiride
    «cloranfenicol, ciertas sulfonamidas de acción prolongada, tetraciclinas, antibióticos tipo quinolonas y claritromicina,»

    AEMPS, section 4.5 · Open on CIMA

  • Hydroxocobalamin
    «Los pacientes tratados con cloranfenicol pueden responder débilmente a Hidroxocobalamina Basi. Las concentraciones séricas de hidroxocobalamina pueden verse disminuidas por anticonceptivos orales…»

    AEMPS, section 4.5 · Open on CIMA

  • Lactoferrin
    «La absorción del hierro puede incrementarse por la administración simultánea de 200 mg de ácido ascórbico y reducirse con la administración simultánea de antiácidos, colestiramina o inhibidores de la…»

    AEMPS, section 4.5 · Open on CIMA

  • Paracetamol
    «Cloranfenicol : Potenciación de la toxicidad de cloranfenicol, por posible inhibición de su metabolismo hepático.»

    AEMPS, section 4.5 · Open on CIMA

  • Phenytoin
    «Drugs that Affect Phenytoin Concentrations: Other Acute alcohol intake, amiodarone, chloramphenicol, chlordiazepoxide, disulfiram, estrogen, fluvastatin, isoniazid, methylphenidate, phenothiazines…»

    FDA, section 7 · Open on DailyMed

  • Rifampicin
    «antibacterianos (p. ej., cloranfenicol, claritromicina, dapsona, doxiciclina, fluoroquinolonas, telitromicina),»

    AEMPS, section 4.5 · Open on CIMA

  • Warfarin
    «Inhibidores enzimáticos: pueden potenciar el efecto anticoagulante, con riesgo de hemorragias, debido a una inhibición de su metabolismo hepático, cuando se administra conjuntamente con: alopurinol…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Chloramphenicol used for?

Chloramphenicol is evaluated for the following indications with varying evidence strength: Typhoid fever (evidence tier B), Acute bacterial meningitis (evidence tier C), Acute infectious diarrhea (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Chloramphenicol?

Common side effects of Chloramphenicol (≥ 1 in 100): Nausea, vomiting, diarrhoea, Glossitis and stomatitis, Headache, Dose-related reversible marrow suppression with leukopenia and reticulocytopenia. See the Safety section for uncommon and serious reactions.

Is Chloramphenicol safe during pregnancy?

A systemic form of chloramphenicol (tablets, injection) is not available in Spain: CIMA lists only eye and skin ointments. According to the FDA label for chloramphenicol sodium succinate injection (Fresenius Kabi, revised October 2016), no animal reproduction studies or adequate, well-controlled studies in pregnant women have been done, and it is not known whether the drug can harm the fetus. Chloramphenicol crosses the placenta, with somewhat lower concentrations in cord blood than in maternal blood. It should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. One case of gray syndrome has been reported in a newborn whose mother received chloramphenicol during labor.

Is Chloramphenicol compatible with breastfeeding?

Chloramphenicol passes into breast milk. Because of serious reactions in the infant, the FDA label puts the choice plainly: either feeding stops or the drug does, weighing how much the mother needs it. That decision is made with the doctor before the course starts, not after the first dose.

Who should not take Chloramphenicol?

Chloramphenicol is contraindicated in: History of hypersensitivity or toxic reaction to chloramphenicol; Trivial infections: colds, influenza, throat infections; Prophylactic use to prevent bacterial infection; Any situation where a less dangerous antibiotic is effective. Full list in the Safety section.

Does Chloramphenicol carry an FDA boxed warning?

FDA boxed warning: chloramphenicol causes serious and fatal blood dyscrasias – aplastic and hypoplastic anaemia, thrombocytopenia, granulocytopenia. Cases of aplastic anaemia later terminating in leukaemia have been reported. Dyscrasias have followed both short and prolonged courses. The drug is not used where less dangerous agents work, in trivial infections, or as prophylaxis. Repeated blood counts are required during treatment.

Official sources

Direct links to regulator labels. Open in a new tab.

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