Chloromycetin Side Effects

Generic Name: chloramphenicol

Please note - some side effects for Chloromycetin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Chloromycetin Side Effects - for the Professional

Chloromycetin

1. 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 aplastic 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.

Paroxysmal nocturnal hemoglobinuria has been reported.

2. Gastrointestinal Reactions

Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.

3. Neurotoxic Reactions

Headache, mild depression, mental confusion, and delirium have been described in patients receiving chloramphenicol. Optic and peripheral neuritis have been reported, usually following long-term therapy. If this occurs, the drug should be promptly withdrawn.

4. Hypersensitivity Reactions

Fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis may occur. Herxheimer’s reactions have occurred during therapy for typhoid fever.

5. "Gray Syndrome"

Toxic reactions including fatalities have occurred in the premature and neonate; the signs and symptoms associated with these reactions have been referred to as the “gray syndrome.” One case of gray syndrome has been reported in a neonate born to a mother having received chloramphenicol during labor. One case has been reported in a 3-month-old infant. The following summarizes the clinical and laboratory studies that have been made on these patients:

a) In most cases therapy with chloramphenicol had been instituted within the first 48 hours of life.

b) Symptoms first appeared after 3 to 4 days of continued treatment with high doses of chloramphenicol.

c) The symptoms appeared in the following order:

(1) abdominal distension with or without emesis;

(2) progressive pallid cyanosis;

(3) vasomotor collapse, frequently accompanied by irregular respiration;

(4) death within a few hours of onset of these symptoms.

d) The progression of symptoms from onset to exitus was accelerated with higher dose schedules.

e)Preliminary blood serum level studies revealed unusually high concentrations of chloramphenicol (over 90 mcg/mL after repeated doses).

f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery.

Chloromycetin Otic Solution

Signs of local irritation with subjective symptoms of itching or burning, angioneurotic edema, urticaria, vesicular and maculopapular dermatitis have been reported in patients sensitive to chloramphenicol and are causes for discontinuing the medication. Similar sensitivity reactions to other materials in topical preparations may also occur. Blood dyscrasias have been reported in association with the use of chloramphenicol.

Side Effects by Body System

Hematologic

Hematologic side effects due to chloramphenicol-induced bone marrow depression are the most significant adverse reactions and have included aplastic anemia, hypoplastic anemia, thrombocytopenia, pancytopenia, and granulocytopenia. Idiosyncratic aplastic anemia occurs in approximately 1 in 20,000 to 1 in 40,000 cases, is fatal in 70% of affected patients, and resolves in only 10% of patients. Reversible bone marrow suppression is more common, and is dose-related. Paroxysmal nocturnal hemoglobinuria has also been reported. Hemolysis may occur in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Aplastic anemia is idiosyncratic and dose-independent. It has been reported in patients who have received intravenous, oral, and topical (including ophthalmologic ointment) chloramphenicol 3 to 12 weeks after initiation of therapy.

Reversible bone marrow suppression may present as early as 5 days after therapy is begun as pancytopenia, is more common with plasma chloramphenicol levels of 25 mcg/mL or more, and may result in high serum iron levels due to lack of bone marrow clearance of iron.

Hypersensitivity

Anaphylaxis may present with urticarial rash, bronchospasm, and angioedema, and is rare.

Hypersensitivity side effects have included fever, macular and vesicular rashes, angioedema, urticaria, anaphylaxis, fever, hypersensitivity myocarditis, and angioedema. Herxheimer's reactions have been reported during treatment of typhoid fever. Extremely rare cases of contact dermatitis have been reported.

Nervous system

Sensorineural hearing loss has been reported after oral administration and after topical administration of chloramphenicol to the outer ear. The proposed mechanism is inhibition of mitochondrial protein synthesis in highly oxidative organs.

Nervous system side effects have included headache, mental confusion, delirium, ototoxicity, sensorineural hearing loss, optic neuritis, peripheral neuritis, and encephalopathy.

Gastrointestinal

Gastrointestinal side effects have infrequently included nausea, vomiting, glossitis, stomatitis, and enterocolitis.

Cardiovascular

Cardiovascular side effects have rarely included cardiomyopathy. The proposed mechanism is inhibition of mitochondrial protein synthesis in highly oxidative organs.

Hepatic

Hepatic side effects have included rare cases of hepatitis.

Other

Gray syndrome has been reported in neonates, premature infants, and infants. It usually appears after 3 to 4 days of chloramphenicol therapy and manifests as abdominal distension with or without vomiting, progressive pallid cyanosis, irregular respiration, vasomotor collapse, and death within a few hours after onset. In one case gray syndrome was reported in a neonate whose mother had received chloramphenicol during labor. High chloramphenicol serum levels (greater than 90 mcg/mL) have been associated with gray syndrome and large doses have been associated with a rapidly fatal course. Symptoms are frequently reversible with complete recovery if chloramphenicol is discontinued immediately.

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