FDA-filed SPL labeling · retrieved through openFDA

Chloramphenicol Injection

Chloramphenicol Injection is a broad-spectrum antibiotic used intravenously for serious bacterial infections when safer alternatives are not effective.

Brand names Chloromycetin InjectionMychel-S InjectionViceton
Drug classes Amphenicol-class Antibacterial
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 10, 2024
AvailabilityRx
Earliest approval/marketing year 1951
FDA-listed product records 2
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Chloramphenicol Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Chloramphenicol Sodium Succinate Injection is a powerful antibiotic reserved for serious bacterial infections when safer options have failed. It carries a significant risk of life-threatening blood disorders, including aplastic anemia, so it requires close medical supervision and regular blood monitoring. This is not a drug for mild infections — it should only be used when your doctor has determined that the benefits clearly outweigh the risks.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Chloramphenicol can cause life-threatening blood disorders, including aplastic anemia — a condition where the bone marrow stops producing blood cells. These reactions can occur after short-term or long-term treatment and can be fatal. Some cases of aplastic anemia linked to chloramphenicol have later developed into leukemia. Because of these dangers, this drug must only be used for serious infections where safer options won't work — never for minor infections like colds, flu, or sore throats, and never just to prevent infection. Blood counts must be monitored throughout treatment. Hospitalization during therapy is strongly recommended so patients can be properly observed.

Read the full warning on DailyMed →

📖 Chloramphenicol Injection: Patient Information Guide

A plain-language walkthrough of Chloramphenicol Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Chloramphenicol Injection is a broad-spectrum antibiotic used intravenously for serious bacterial infections that cannot be safely treated with other antibiotics. It is used only when safer alternatives are not effective.

  • Chloramphenicol Sodium Succinate Injection is used to treat serious infections caused by Haemophilus influenzae
  • Chloramphenicol Sodium Succinate Injection is used to treat infections caused by Salmonella species, including Salmonella typhi (typhoid fever)
  • Chloramphenicol Sodium Succinate Injection is used to treat infections caused by Rickettsia (a type of bacteria spread by ticks and mites)
  • Chloramphenicol Sodium Succinate Injection is used to treat infections caused by the lymphogranuloma-psittacosis group of organisms
  • It must not be used for minor infections (colds, flu, sore throat) or as a preventive antibiotic
⚙️How it works

Chloramphenicol works by interfering with how bacteria build proteins. Specifically, it blocks the transfer of amino acids (protein building blocks) to the ribosome — the cell's protein-making machinery. Without the ability to produce essential proteins, bacteria cannot grow or multiply. This effect is mainly bacteriostatic, meaning it stops bacteria from reproducing rather than directly killing them.

Chloramphenicol penetrates well into body fluids, including the cerebrospinal fluid (the fluid around the brain and spinal cord), even when there is no meningitis (brain lining inflammation). It is active against a broad range of both gram-negative and gram-positive bacteria.

💊How it's taken

Chloramphenicol Sodium Succinate is given intravenously — into a vein — by a healthcare professional. It is not a medication you administer at home. Treatment typically takes place in a hospital, where your blood can be monitored regularly.

  • Your prescriber will determine how often doses are given based on your infection and condition
  • Do not adjust or skip doses without talking to your care team
  • Blood tests are required throughout treatment — do not miss these appointments
🤒Side effects — in detail

Like all antibiotics, chloramphenicol can cause side effects — some minor, some serious.

  • Nausea, vomiting, or diarrhea
  • Mouth sores (glossitis or stomatitis)
  • Headache
  • Mild depression, mental confusion, or delirium
  • Fever or skin rash
  • Hives or swelling (allergic reaction)

The most dangerous side effects involve the blood and bone marrow (aplastic anemia, dangerously low blood cell counts) — these can appear weeks or even months after treatment ends. Tell your doctor right away if you feel unusually tired, bruise easily, or notice any unexpected bleeding.

⚠️Warnings & precautions
  • Bone marrow depression and aplastic anemia: The most serious risk is that chloramphenicol can damage the bone marrow, leading to aplastic anemia — a potentially fatal condition where the body can't make enough blood cells. This can be irreversible and can occur even after short-term use.
  • Risk of leukemia: Some cases of aplastic anemia linked to this drug have later progressed to leukemia.
  • Gray syndrome in newborns: Premature babies and newborns are at risk of a serious toxic reaction called gray syndrome, which can cause abdominal swelling, bluish-gray skin, circulatory collapse, and death. This has also occurred in an infant whose mother received chloramphenicol during labor.
  • Optic and peripheral neuritis: Nerve damage affecting vision or sensation in the limbs has been reported, especially with long-term use. Stop the drug and contact your doctor if this occurs.
  • Blood monitoring: Regular blood counts are required throughout therapy. Even so, testing cannot always detect bone marrow damage before aplastic anemia develops.
  • Hospitalization recommended: Because of the serious risks, patients should ideally be hospitalized during treatment.
🔀What it interacts with

Chloramphenicol has an important drug interaction to be aware of during treatment.

  • Other bone marrow-suppressing drugs: Taking other medications that can reduce bone marrow activity at the same time as chloramphenicol significantly raises the risk of life-threatening blood disorders. Your doctor needs to know all medications you are taking before starting this drug.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Previous allergic or toxic reaction to chloramphenicol: Do not use this drug if you have ever had a hypersensitivity or toxic reaction to it — it is contraindicated.
  • Minor infections or prevention: Chloramphenicol must not be used for colds, flu, sore throats, or to prevent bacterial infections.
  • Newborns and premature infants: This population is at high risk of the potentially fatal gray syndrome; use requires extreme caution and close monitoring.
  • Pregnancy and labor: The drug crosses the placenta. Newborns of mothers given chloramphenicol during labor must be watched for signs of gray syndrome.
  • Breastfeeding: Chloramphenicol is detected in breast milk; discuss with your doctor before use.
  • Concurrent bone marrow-suppressing medications: Tell your doctor about all medications — combining drugs that suppress bone marrow increases serious risk.
  • Ongoing blood monitoring: You must have regular blood tests throughout treatment; this is not optional.
📡Pharmacodynamics — effects in the body

Chloramphenicol exerts mainly a bacteriostatic effect — it stops bacteria from reproducing rather than killing them directly — against a wide range of gram-negative and gram-positive bacteria. It distributes throughout the body, reaching high concentrations in the liver and kidney, and lower but still measurable concentrations in the cerebrospinal fluid, pleural fluid, saliva, breast milk, and eye fluids.

🔬Pharmacokinetics — how your body processes it

Chloramphenicol distributes rapidly throughout the body after administration, though distribution is not uniform — concentrations are highest in the liver and kidneys and lowest in the brain and cerebrospinal fluid. It does cross into the cerebrospinal fluid even without meningitis, reaching about half the blood concentration. The drug also crosses the placenta, appearing in cord blood at somewhat lower levels than in maternal blood. Most of the drug is excreted in the urine, primarily as inactive metabolites, with a smaller portion as active (free) chloramphenicol.

📦How to store it

Store at 20° to 25°C (68° to 77°F) .

📄 Written from Chloramphenicol Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

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Supplements & herbs that interact with Chloramphenicol Injection

32 supplements and herbal products have documented interactions with Chloramphenicol Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 30
  • Minor · 2
Every supplement checked against Chloramphenicol Injection — ranked by severity The full interaction hub: 30 moderate · 2 minor · every one linked to its full report. Check Chloramphenicol Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

8

Nutrient depletion considerations

Chloramphenicol Injection has been associated with lower levels of 8 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 6
  • Moderate · 2
See the full Chloramphenicol Injection nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Chloramphenicol Injection — the kind of thing our pharmacy team would talk through with you at the counter.

Why is this antibiotic only used for serious infections? Why not just use it for any bacterial infection?
Chloramphenicol carries a risk of causing aplastic anemia — a serious, sometimes fatal condition where your bone marrow stops making blood cells. Because safer antibiotics exist for most common infections, chloramphenicol is kept as a last resort for infections where those alternatives won't work. Using it for something minor like a cold or sore throat would put you at unnecessary risk. Your doctor has made a careful judgment that the infection you have is serious enough to justify it.
What is aplastic anemia, and how would I know if I was developing it?
Aplastic anemia is a condition where the bone marrow — the spongy tissue inside your bones — stops producing enough red blood cells, white blood cells, and platelets. Warning signs include extreme fatigue, unusual bruising or bleeding, and increased infections. The tricky part is that this can show up weeks or even months after treatment ends, not just while you're on the drug. That's why your doctor will keep monitoring your blood even after you've finished the medication.
I'll be in the hospital during treatment — why can't I just take this at home?
Because chloramphenicol requires close, regular monitoring of your blood counts to catch any early signs of bone marrow problems. The FDA label specifically recommends hospitalization so that your care team can observe you carefully and run the necessary tests. It's not about how the IV is given — it's about making sure any dangerous changes in your blood are caught as early as possible.
Are there any medicines I should avoid while on chloramphenicol?
Yes — you should avoid other drugs that can suppress your bone marrow at the same time as chloramphenicol. Combining them raises your risk of serious blood problems significantly. Make sure your entire care team knows every medication you're taking, including over-the-counter drugs and supplements, before you start treatment.
Is this medication safe during pregnancy or if I'm breastfeeding?
Chloramphenicol does cross the placenta and has been detected in breast milk. If a mother received it during labor, the newborn needs close monitoring for a dangerous reaction called gray syndrome, which can cause life-threatening symptoms in newborns. If you are pregnant or breastfeeding, make sure your doctor knows — the risks and benefits will need to be carefully weighed before using this drug.
What is 'gray syndrome' and should I be worried about it?
Gray syndrome is a serious toxic reaction seen mainly in premature babies and newborns who receive chloramphenicol. It causes symptoms like abdominal swelling, a bluish-gray skin color, collapse of circulation, and, in severe cases, death. If the drug is stopped early when the first signs appear, recovery is possible. Adults are not typically at risk for gray syndrome, but if you're a new parent whose infant is being treated, it's essential that the medical team monitors your baby extremely closely.
Is Chloramphenicol Injection available over the counter?
Chloramphenicol Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Chloramphenicol Injection first available?
Chloramphenicol Injection has been available in the United States since at least 1951, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Chloramphenicol Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Chloramphenicol Injection comes

Chloramphenicol Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a vein
How this form is used
What it may be used for
  • Chloramphenicol Sodium Succinate is used intravenously to treat serious infections caused by susceptible bacteria, including Haemophilus influenzae, Salmonella typhi (typhoid fever), Rickettsia, and the lymphogranuloma-psittacosis group
  • Chloramphenicol Sodium Succinate is used only when less dangerous antibiotics are not effective
Important instructions
  • Chloramphenicol Sodium Succinate is administered directly into a vein (intravenously) by a healthcare professional
  • Chloramphenicol Sodium Succinate therapy requires regular blood tests throughout treatment to monitor for blood cell changes
  • Hospitalization during Chloramphenicol Sodium Succinate treatment is strongly recommended to allow close monitoring
Available strengths 1 strength
2 FDA-listed product records

📊 Chloramphenicol Injection across the U.S. market

How Chloramphenicol Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
1
Manufacturers
1
Brand names
2
FDA-listed product records
1951
First marketed

📈 How widely Chloramphenicol Injection is used

A general measure of how commonly Chloramphenicol Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Chloramphenicol Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

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Medicaid prescriptions filled (Q1–Q4 2025)
$370 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Chloramphenicol Injection prescribed? Of the 1,596 medications we measure, Chloramphenicol Injection ranks #1,559 by Medicaid prescriptions — more than 2% of them.

Where Chloramphenicol Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Chloramphenicol Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

chloramphenicol 100 MG/ML Injectable Solution

32 Medicaid prescriptions (Q1–Q4 2025) 100% of Chloramphenicol Injection prescriptions shown $370 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 239200

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Chloramphenicol Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Chloramphenicol Injection NDCs with Medicaid activity.

🔍 Compare Chloramphenicol Injection products

A representative set of FDA-listed product records for Chloramphenicol Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Injection
1 g/10 mL Intravenous Fresenius Kabi USA, LLC × 2 listings ANDA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Chloramphenicol Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Chloramphenicol Injection RxCUI 2348 10 dose forms · 13 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 370500 In current FDA listings
    Clinical drug / strength (SCD) 100 MG/ML RxCUI 239200
  2. Dose form (SCDF) Ophthalmic Ointment RxCUI 95104 No current FDA listing
    Clinical drug / strength (SCD) 0.01 MG/MG RxCUI 309172
  3. Dose form (SCDF) Ophthalmic Solution RxCUI 371377 No current FDA listing
    Clinical drug / strength (SCD) 2.5 MG/ML RxCUI 245581 5 MG/ML RxCUI 309174
  4. Dose form (SCDF) Oral Capsule RxCUI 371376 No current FDA listing
    Clinical drug / strength (SCD) 250 MG RxCUI 197463
  5. Dose form (SCDF) Oral Solution RxCUI 371380 No current FDA listing
  6. Dose form (SCDF) Oral Suspension RxCUI 371379 No current FDA listing
    Clinical drug / strength (SCD) 25 MG/ML RxCUI 105265
  7. Dose form (SCDF) Oral Tablet RxCUI 371381 No current FDA listing
    Clinical drug / strength (SCD) 250 MG RxCUI 252338 500 MG RxCUI 252671 1000 MG RxCUI 1232971
  8. Dose form (SCDF) Otic Solution RxCUI 371378 No current FDA listing
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 204699 50 MG/ML RxCUI 250653 100 MG/ML RxCUI 250652
  9. Dose form (SCDF) Topical Cream RxCUI 377640 No current FDA listing
  10. Dose form (SCDF) Topical Ointment RxCUI 393150 No current FDA listing
    Clinical drug / strength (SCD) 0.01 MG/MG RxCUI 251704

Look up RxCUI 2348 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Chloromycetin Injection Mychel-S Injection Viceton

🏭 Manufacturers & labelers

Fresenius Kabi USA, LLC 2

RxNorm drug class

Chloramphenicol Injection belongs to the Amphenicol-class Antibacterial class.

Pharmacologic class Amphenicol-class Antibacterial
Drug family (ATC) Other antibiotics for topical use, Antiinfectives for treatment of acne, Antibiotics

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 10, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Chloramphenicol Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Chloramphenicol Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
2
Distinct labelers/manufacturers represented
1
Linked representative label
Fresenius Kabi USA, LLC
Linked label effective
Oct 10, 2024
Composite sections available
12
Linked SPL Set ID
aed29594-211d-49ef-813f-131975a8d0e3
Linked SPL Document ID
f0af962d-5024-47cf-b7a0-da9b5ff3c994
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.