CHLORAMPHENICOL: 488 Adverse Event Reports & Safety Profile
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Drug Class: Amphenicol-class Antibacterial [EPC] · Route: INTRAVENOUS · Manufacturer: Fresenius Kabi USA, LLC · FDA Application: 050091 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 195108 · Latest Report: 20241021
What Are the Most Common CHLORAMPHENICOL Side Effects?
All CHLORAMPHENICOL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 106 | 21.7% | 88 | 72 |
| Vomiting | 96 | 19.7% | 76 | 58 |
| Drug ineffective | 95 | 19.5% | 56 | 52 |
| Multiple organ dysfunction syndrome | 92 | 18.9% | 83 | 62 |
| Abdominal pain | 88 | 18.0% | 76 | 56 |
| Sepsis | 86 | 17.6% | 85 | 64 |
| Condition aggravated | 85 | 17.4% | 74 | 64 |
| Abdominal distension | 83 | 17.0% | 80 | 60 |
| General physical health deterioration | 83 | 17.0% | 82 | 60 |
| Hyponatraemia | 83 | 17.0% | 82 | 60 |
| Stress | 81 | 16.6% | 81 | 59 |
| Nausea | 79 | 16.2% | 70 | 50 |
| Somnolence | 76 | 15.6% | 71 | 63 |
| Ascites | 73 | 15.0% | 72 | 51 |
| Appendicitis | 72 | 14.8% | 72 | 51 |
| Cardiogenic shock | 72 | 14.8% | 72 | 51 |
| Constipation | 72 | 14.8% | 71 | 50 |
| Appendicolith | 71 | 14.6% | 71 | 50 |
| Ventricular fibrillation | 71 | 14.6% | 71 | 50 |
| Incorrect route of product administration | 68 | 13.9% | 56 | 52 |
Who Reports CHLORAMPHENICOL Side Effects? Age & Gender Data
Gender: 43.0% female, 57.0% male. Average age: 55.6 years. Most reports from: GB. View detailed demographics →
Is CHLORAMPHENICOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 6 | 0 | 0 |
| 2008 | 1 | 1 | 1 |
| 2009 | 2 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 3 | 0 | 1 |
| 2013 | 7 | 0 | 2 |
| 2014 | 6 | 1 | 5 |
| 2015 | 12 | 0 | 11 |
| 2016 | 6 | 0 | 0 |
| 2017 | 5 | 0 | 4 |
| 2018 | 6 | 1 | 3 |
| 2019 | 12 | 0 | 4 |
| 2020 | 41 | 28 | 27 |
| 2021 | 8 | 3 | 2 |
| 2022 | 19 | 0 | 10 |
| 2023 | 1 | 0 | 1 |
| 2024 | 2 | 0 | 1 |
What Is CHLORAMPHENICOL Used For?
CHLORAMPHENICOL vs Alternatives: Which Is Safer?
Official FDA Label for CHLORAMPHENICOL
Official prescribing information from the FDA-approved drug label.
Drug Description
DESCRIPTION: Chloramphenicol is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. Sensitivity testing is essential to determine its indicated use, but may be performed concurrently with therapy initiated on clinical impression that one of the indicated conditions exists (see INDICATIONS AND USAGE section). When reconstituted as directed, each vial contains a sterile solution equivalent to 100 mg of chloramphenicol per mL (1 g/10 mL). Each gram (10 mL of a 10% solution) of chloramphenicol sodium succinate contains approximately 52 mg (2.25 mEq) of sodium. The chemical name for chloramphenicol sodium succinate is D-threo-(-)-2, 2-Dichloro-N-[β-hydroxy-α-(hydroxymethyl)-p-nitrophenethyl] acetamide α-(sodium succinate). The structural formula is: structure
FDA Approved Uses (Indications)
Uses Temporarily relieves discomfort due to kidney issues, including occasional frequent urination, foamy urine, headaches, increased blood pressure levels, increased tiredness, itching, lower back discomfort, nausea, loss of appetite, vomiting, need to urinate at night, muscle twitching, and cramps.* *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.
Dosage & Administration
How to Use Mix with half a cup of water 3-4 times per day.
Ages
12 or older, 10 drops.
Ages
12-2, 5 drops.
Ages
2 and under, consult your Doctor.
Contraindications
CONTRAINDICATIONS: 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.
Known Adverse Reactions
ADVERSE REACTIONS: 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. Paroxysmal nocturnal hemoglobinuria has been reported.
Gastrointestinal Reactions
Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.
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.
Hypersensitivity Reactions
Fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis may occur. Herxheimer’s reactions have occurred during therapy for typhoid fever. "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.
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. Paroxysmal nocturnal hemoglobinuria has been reported.
Gastrointestinal Reactions
Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.
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.
Hypersensitivity Reactions
Fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis may occur. Herxheimer’s reactions have occurred during therapy for typhoid fever.
"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.
FDA Boxed Warning
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.
Warnings
Warnings and Storage: Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place. *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.
Precautions
PRECAUTIONS: General Repeated courses of chloramphenicol treatment should be avoided if at all possible. Treatment should not be continued longer than required to produce a cure with little or no risk or relapse of the disease. Excessive blood levels may result from administration of the recommended dose to patients with impaired liver or kidney function. The dosage should be adjusted accordingly, or preferably, the blood concentration should be determined at appropriate intervals. The use of this antibiotic, as with other antibiotics, may result in an overgrowth of nonsusceptible organisms, including fungi. If infections caused by nonsusceptible organisms appear during therapy, appropriate measures should be taken.
Laboratory Tests
Baseline blood studies should be followed by periodic blood studies approximately every two days during therapy. The drug should be discontinued upon appearance of reticulocytopenia, leukopenia, thrombocytopenia, anemia or any other blood study findings attributable to chloramphenicol. However, it should be noted that such studies do not exclude the possible later appearance of the irreversible type of bone marrow depression.
Drug Interactions
Concurrent therapy with other drugs that may cause bone marrow depression should be avoided. Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or humans to evaluate the possibility of these effects with chloramphenicol.
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.
Nursing Mothers
Chloramphenicol is excreted in human milk following oral administration of the drug. Because of the potential for serious adverse reactions in nursing infants from chloramphenicol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see ADVERSE REACTIONS, “Gray Syndrome” ).
Pediatric Use
Precaution should be used in therapy of premature and full-term neonates and infants to avoid “gray syndrome” toxicity. Due to immature metabolic processes in the neonate and infant, excessive blood levels may result from administration of the recommended dose. The dosage should be adjusted accordingly or, preferable, the blood concentration should be determined at appropriate intervals (see ADVERSE REACTIONS , "Gray Syndrome" ). See DOSAGE AND ADMINISTRATION for dosing information in the pediatric population.
Geriatric Use
Clinical studies of chloramphenicol sodium succinate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Each gram (10 mL of a 10% solution) of chloramphenicol sodium succinate contains approximately 52 mg (2.25 mEq) of sodium.
Drug Interactions
Drug Interactions Concurrent therapy with other drugs that may cause bone marrow depression should be avoided.
Active Ingredient
Active Ingredients: ChloremphenicolD200+200C, HypophysisD200+200C, Lobelia ErenusD30+100C(Tailing Lobelia), StreptomycinD200+200C, UreaD200+200C
Inactive Ingredients
Ingredients Inactive: Alcohol Base to Preserve Remedy