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Chloromycetin Sodium Succinate Side Effects

Generic Name: chloramphenicol

Note: This document contains side effect information about chloramphenicol. Some of the dosage forms listed on this page may not apply to the brand name Chloromycetin Sodium Succinate.

For the Consumer

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.

Side effects requiring immediate medical attention

Along with its needed effects, chloramphenicol (the active ingredient contained in Chloromycetin Sodium Succinate) 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

Side effects not requiring immediate medical attention

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

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]

References

1. Doona M, Walsh JB "Use of chloramphenicol as topical eye medication: time to cry halt? bone marrow aplasia also occurs with ocular use." BMJ 310 (1995): 1217-8

2. "Product Information. Chloromycetin (chloramphenicol)." Parke-Davis, Morris Plains, NJ.

3. Del Giacco GS, Petrini MT, Jannelli S, Carcassi U "Fatal bone marrow hypoplasia in a shepherd using chloramphenicol spray." Lancet 1 (1981): 945

4. Fraunfelder FT, Bagby GC, Kelly DJ "Fatal aplastic anemia following topical administration of ophthalmic chloramphenicol." Am J Ophthalmol 93 (1982): 356-60

5. Smith AL, Weber A "Pharmacology of chloramphenicol." Pediatr Clin North Am 30 (1983): 209-36

6. Calderwood SB, Moellering RC "Common adverse effects of antibacterial agents on major organ systems." Surg Clin North Am 60 (1980): 65-81

7. Abrams SM, Degnan TJ, Vinciguerra V "Marrow aplasia following topical application of chloramphenicol eye ointment." Arch Intern Med 140 (1980): 576-7

8. West BC, DeVault GA Jr, Clement JC, Williams DM "Aplastic anemia associated with parenteral chloramphenicol: review of 10 cases, including the second case of possible increased risk with cimetidine." Rev Infect Dis 10 (1988): 1048-51

9. Alavi JB "Aplastic anemia associated with intravenous chloramphenicol." Am J Hematol 15 (1983): 375-9

10. Finegold SM "Therapy for infections due to anaerobic bacteria: an overview." J Infect Dis 135 Suppl (1977): S25-9

11. Shalit I, Marks MI "Chloramphenicol in the 1980s." Drugs 28 (1984): 281-91

12. Diskin C "Paroxysmal nocturnal hemoglobinuria after chloramphenicol therapy." Mayo Clin Proc 80 (2005): 1392, 1394

13. Farber BF, Brody JP "Rapid development of aplastic anemia after intravenous chloramphenicol and cimetidine therapy." South Med J 74 (1981): 1257-8

14. Liphshitz I, Loewenstein A "Anaphylactic reaction following application of chloramphenicol eye ointment." Br J Ophthalmol 75 (1991): 64

15. Van Joost T, Dikland W, Stolz E, Prens E "Sensitization to chloramphenicol: a persistent problem." Contact Dermatitis 14 (1986): 176-8

16. Palchick BA, Funk EA, McEntire JE, Hamory BH "Anaphylaxis due to chloramphenicol." Am J Med Sci 288 (1984): 43-5

17. Kounis GN, Kouni SA, Chiladakis JA, Kounis NG "Comment: Mesalamine-Associated Hypersensitivity Myocarditis in Ulcerative Colitis and the Kounis Syndrome (February)." Ann Pharmacother 43 (2009): 393-4

18. Perkins JB, Raasch RH "Hypersensitivity reaction following chloramphenicol administration in a patient with typhoid fever." Drug Intell Clin Pharm 21 (1987): 343-5

19. Schewach-Millet M, Shpiro D "Urticaria and angioedema due to topically applied chloramphenicol ointment." Arch Dermatol 121 (1985): 587

20. Iqbal SM, Srivatsav CBP "Chloramphenicol ototoxicity." J Laryngol Otol 98 (1984): 523-5

21. Biancaniello T, Meyer R, Kaplan S "Chloramphenicol and cardiotoxicity." J Pediatr 98 (1981): 828-30

22. Phelps SJ, Tsiu W, Barrett FF, et al "Chloramphenicol-induced cardiovascular collapse in an anephric patient." Pediatr Infect Dis J 6 (1987): 285-8

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.