FDA-filed SPL labeling · retrieved through openFDA

Ketamine

Ketamine is a fast-acting general anesthetic used for surgical and diagnostic procedures, either alone or alongside other anesthetic agents.

Brand names KetasetKetalar
Drug classes ⓘ General Anesthesia
Rx Schedule CIII Forms 2 Routes Intramuscular; Intravenous · Intramuscular, 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 16 clinical label sets 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 effectiveMar 27, 2026
Clinical labels in scope ⓘ16
AvailabilityRx
Earliest approval/marketing year ⓘ1970
FDA-listed product records ⓘ88
Boxed warningNone found in compared labels
How we combine label and product data →
⭐ Ketamine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ketamine is a fast-acting general anesthetic given by injection in medical settings by trained providers — not a medication taken at home. It works quickly and powerfully, which is why careful monitoring of breathing, heart rate, and blood pressure is essential throughout. If you or a family member is scheduled to receive ketamine, your care team will manage all aspects of its use, but it's worth knowing the most common after-effects — like temporary confusion or vivid dreams — so you're not caught off guard during recovery.
How we write & review this content — our editorial policy →

📖 Ketamine: Patient Information Guide

A plain-language walkthrough of Ketamine — 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▾

Ketamine hydrochloride injection is an FDA-approved general anesthetic used in controlled medical settings. Both Ketalar and Ketamine Hydrochloride injection are approved for the same indications:

  • As the sole anesthetic for diagnostic or surgical procedures that do not require skeletal muscle relaxation
  • To induce (start) anesthesia before other general anesthetic agents are administered
  • As a supplement to other anesthetic agents during a procedure
⚙️How it works▾

Ketamine blocks a specific brain receptor called the NMDA receptor — a key player in pain perception and conscious awareness. By blocking this receptor, ketamine creates a unique state called dissociative anesthesia: you're deeply sedated and completely free of pain, but many of your protective reflexes (like keeping your airway clear) remain active. At the same time, ketamine stimulates the cardiovascular system, raising blood pressure and heart rate, and acts as a potent bronchodilator (airway opener), which makes it particularly useful for patients at risk of airway spasm during anesthesia.

💊How it's taken▾

Ketamine injection is given only in a clinical setting by or under the supervision of an anesthesia-trained physician — never self-administered. The route (intravenous or intramuscular) and amount are determined by the clinical situation and the patient's needs.

  • Intravenous (IV) administration is given slowly; rapid injection increases the risk of breathing problems
  • Intramuscular (IM) injection is also an option and tends to cause fewer emergence reactions
  • Additional doses may be given during a procedure as needed to maintain anesthesia
  • When used alongside diazepam, the two drugs must be given separately — never mixed in the same syringe or IV bag
🤒Side effects — in detail▾

The most common side effects with ketamine injection are a rise in blood pressure and heart rate, and emergence reactions as the drug wears off.

  • Emergence reactions: vivid dreams, hallucinations, confusion, or agitation during recovery (occurs in about 1 in 8 patients)
  • Elevated blood pressure and faster heart rate during the procedure
  • Nausea and vomiting
  • Involuntary rapid eye movements (nystagmus)
  • Increased saliva production
  • Double vision
  • Temporary skin redness or a mild rash at the injection site
  • Muscle stiffness or spasm-like movements during administration

Serious reactions — including severe breathing problems, a dangerous drop in blood pressure, airway spasm, or signs of a severe allergic reaction — require immediate medical attention. With repeated use over time, bladder damage and liver injury have been reported.

⚠️Warnings & precautions▾
  • Blood pressure changes: Ketamine almost always raises blood pressure and heart rate temporarily. It is contraindicated in anyone for whom a blood pressure spike would be dangerous. Drops in blood pressure and irregular heartbeats can also occur and require continuous monitoring.
  • Emergence reactions: About 12% of patients experience confusion, hallucinations, or agitation during recovery. Keeping the recovery environment calm and quiet helps. These effects are generally short-lived with no lasting psychological impact from anesthetic use.
  • Breathing: Respiratory depression (dangerously slowed breathing) can occur if too much is given too quickly. Emergency airway equipment must always be on hand.
  • Children under 3 years: Use lasting longer than 3 hours may carry a risk of long-term cognitive effects on the developing brain. Providers weigh these risks against the necessity of the procedure.
  • Liver injury with repeated use: Recurrent ketamine use has been linked to liver and bile duct problems. Baseline and ongoing liver function tests are recommended for patients receiving it repeatedly.
  • Urinary tract damage: Long-term or abusive use has been linked to serious bladder and urinary tract complications, including reduced bladder capacity and kidney injury.
  • Raised intracranial pressure: Ketamine can increase pressure inside the skull; patients with this condition need close neurological monitoring.
🔀What it interacts with▾

Ketamine can interact with several types of medications, sometimes with serious consequences. Tell your care team about everything you take before receiving ketamine.

  • Opioid pain medicines, benzodiazepines, and alcohol/other CNS depressants: Combining these with ketamine can cause life-threatening sedation, breathing failure, or coma — even death.
  • Theophylline or aminophylline (used for asthma or breathing problems): May lower the seizure threshold when used together; an alternative anesthetic should be considered.
  • Sympathomimetics (stimulant-type drugs) and vasopressin (a blood pressure agent): Can amplify ketamine's effects on the heart and blood pressure, requiring close vital sign monitoring and possible dose adjustments.

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▾
  • Do not receive ketamine if you have a condition where a significant rise in blood pressure would be dangerous
  • Do not receive it if you have a known allergy to ketamine or any of its inactive ingredients
  • Tell your provider if you are pregnant — ketamine use in pregnancy, including during delivery, is not recommended because safety has not been established
  • If you are breastfeeding, ketamine and its metabolites pass into breast milk; your infant should be monitored for sedation and breathing changes
  • For young children (especially under 3 years): prolonged anesthesia (over 3 hours) may carry risks to brain development; providers carefully weigh benefits versus risks
  • Older adults should be started at lower doses, given the higher likelihood of heart, liver, or kidney concerns and greater sensitivity to the drug
  • Tell your care team if you have elevated pressure inside the skull — you will need close neurological monitoring
  • Disclose all medications, including theophylline, opioids, benzodiazepines, stimulants, and any herbal or over-the-counter products
🚑If you take too much▾

Too much ketamine — or giving it too fast — can cause dangerous changes in heart rate and blood pressure, severely slowed breathing, and in serious cases, breathing may stop entirely (apnea). Assisted or mechanical ventilation may be needed. In documented cases of unintentional overdose at up to ten times the usual dose, patients had a prolonged but full recovery with proper support.

📡Pharmacodynamics — effects in the body▾

Ketamine produces a dissociative anesthetic state — profound pain relief and sedation while generally preserving airway reflexes and breathing. It raises blood pressure, heart rate, and cardiac output, typically peaking within a few minutes of injection and returning to baseline within about 15 minutes. Ketamine is also a potent bronchodilator, making it especially useful in patients at risk of airway spasm. At the same time, it can cause involuntary eye movements, increased saliva, and spontaneous limb movements during anesthesia.

🔬Pharmacokinetics — how your body processes it▾

After intravenous injection, ketamine acts very quickly — the anesthetic effect begins within about 30 seconds and corresponds to an early distribution phase lasting roughly 45 minutes with a short half-life of 10–15 minutes. The drug is broken down primarily in the liver (mainly by enzymes CYP2B6 and CYP3A4) into an active metabolite called norketamine, which has about one-third of ketamine's potency. Ketamine then redistributes from the brain to other body tissues over a longer phase of about 2.5 hours, which is why the anesthetic effect fades even as the drug is still present in the body.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). Protect from light.

📄 Written from Ketamine’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 →

🩺 Pharmacist Counseling Corner

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

What exactly is ketamine used for — I keep hearing about it in the news but my doctor says it's for surgery? ▾
The FDA-approved use of ketamine injection is as a general anesthetic — it's given in hospitals and surgical centers to put people into a deep sedated state for procedures, either on its own or alongside other anesthetic drugs. You may have heard about it in the news in the context of mental health treatments, but that would be an off-label use and is not what the FDA-approved injection products are indicated for.
Will I be completely unconscious, or will I know what's happening? ▾
Ketamine creates what's called a 'dissociative' state — you won't feel pain and you'll be deeply sedated, but it works a little differently from traditional anesthesia. Your protective reflexes, like keeping your airway clear, tend to stay active. Most people have no memory of the procedure itself, though during recovery some people experience vivid dreams, hallucinations, or a brief period of confusion — this is called an emergence reaction and it's normal and temporary.
What's this I've heard about weird feelings or hallucinations when waking up from ketamine? ▾
That's a real and well-recognized effect called an emergence reaction. About 1 in 8 people experience it — it can range from pleasant, dream-like feelings to vivid imagery or brief confusion and agitation as the drug wears off. It usually only lasts a few hours and doesn't cause any lasting psychological effects from a single anesthetic use. Your care team will keep things quiet and calm around you during recovery to help reduce it.
Are there any medications I take at home that could be a problem? ▾
Yes, and this is really important to share with your anesthesia team. The biggest concerns are opioid pain medicines, benzodiazepines (like Valium or Xanax), and anything else that slows down the brain — including alcohol — because combining these with ketamine can cause dangerously slowed breathing. If you use theophylline or aminophylline for a breathing condition, that's also important to flag. Make sure your team has a full list of everything you take.
Is ketamine safe during pregnancy? ▾
Ketamine use during pregnancy — including during labor and delivery — is not recommended because its safety hasn't been clearly established. Animal studies have shown some developmental concerns, and there are limited human data. If you are pregnant or think you might be, tell your care team before any procedure so they can choose the safest approach for you and your baby.
My child needs surgery — should I be worried about ketamine affecting their brain? ▾
This is a question many parents have, and it's completely understandable. Animal studies have raised some concern about anesthetic drugs like ketamine affecting the developing brain, especially in children under 3 when exposure lasts longer than 3 hours. However, the real-world significance in children is still not fully clear, and anesthesia is often essential for necessary procedures. Your child's care team weighs these potential risks carefully against the need for the procedure, and no specific anesthetic drug has been proven safer than another.
Is Ketamine available over the counter? ▾
Ketamine 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.
Is Ketamine a controlled substance? ▾
Yes — Ketamine is a federally controlled substance (Schedule III) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.
When was Ketamine first available? ▾
Ketamine has been available in the United States since at least 1970, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Ketamine? ▾
Ketamine is supplied by 32 manufacturers listed in the FDA NDC Directory, including Civica, Inc., Henry Schein, Inc., Hospira, Inc..

💬 Answers drafted from Ketamine’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

🌿Drug & Supplement CheckerKetamine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Ketamine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Ketamine comes

Ketamine is available in 2 forms. 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 muscle · Into a vein
Brands Ketalar
How this form is used
What it may be used for
  • Ketalar and Ketamine Hydrochloride injection are used as the sole anesthetic for diagnostic or surgical procedures not requiring full muscle relaxation
  • Ketalar and Ketamine Hydrochloride injection are used to induce anesthesia before other general anesthetic agents are given
  • Ketalar and Ketamine Hydrochloride injection are used as a supplement alongside other anesthetic agents
Important instructions
  • Ketalar and Ketamine Hydrochloride injection must be administered only by or under the direction of a physician experienced in general anesthesia
  • Vital signs must be monitored continuously and emergency airway equipment must be immediately available during administration
  • Ketalar: the 100 mg/mL concentration must not be given intravenously without proper dilution first, and must be used immediately after dilution
  • Ketamine Hydrochloride injection: barbiturates and ketamine should never be mixed in the same syringe due to chemical incompatibility
Available strengths 3 strengths
10 mg/mL 50 mg/mL 100 mg/mL
72 FDA-listed product records ⓘ

Topical cream, ointment or gel

By mouth
Available strengths 1 strength
1 kg/kg
1 FDA-listed product record ⓘ

📊 Ketamine across the U.S. market

How Ketamine 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.

2
Dose forms ⓘ
32
Manufacturers
2
Brand names
88
FDA-listed product records ⓘ
1970
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Civica, Inc.9%
Henry Schein, Inc.9%
Hospira, Inc.8%
Par Pharmaceutical, Inc.7%
Fresenius Kabi USA, LLC7%
Gland Pharma Limited7%
Other makers53%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Ketamine is used

A general measure of how commonly Ketamine 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 Ketamine 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.

6,625
Medicaid prescriptions filled (Q1–Q4 2025)
$327,396 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ketamine prescribed? Of the 1,596 medications we measure, Ketamine ranks #1,001 by Medicaid prescriptions — more than 37% of them.

Where Ketamine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,001 of 1,596
#996 Diroximel Fumarate 6,829 Rx #997 Octreotide Injection 6,763 Rx #998 Olaparib 6,734 Rx #999 Blinatumomab Injection 6,717 Rx #1,000 Relugolix 6,636 Rx #1,001 Ketamine 6,625 Rx #1,002 Baricitinib 6,573 Rx #1,003 Nizatidine 6,555 Rx #1,004 Panitumumab Injection 6,524 Rx #1,005 Ampicillin Injection 6,519 Rx #1,006 Ado-trastuzumab Emtans... 6,495 Rx

Utilization by Ketamine 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.

The 50 mg/mL injectable solution is the most-dispensed Ketamine product — about 37% of these Medicaid prescriptions.

ketamine 50 MG/ML Injectable Solution Most dispensed

2,481 Medicaid prescriptions (Q1–Q4 2025) 37% of Ketamine prescriptions shown $188,510 gross reimbursement (before rebates) ≈ $76 per prescription (gross)

Summed across the 7 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238084

ketamine 10 MG/ML Injectable Solution

2,364 Medicaid prescriptions (Q1–Q4 2025) 36% of Ketamine prescriptions shown $71,318 gross reimbursement (before rebates) ≈ $30 per prescription (gross)

Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238082

ketamine 100 MG/ML Injectable Solution

1,780 Medicaid prescriptions (Q1–Q4 2025) 27% of Ketamine prescriptions shown $67,568 gross reimbursement (before rebates) ≈ $38 per prescription (gross)

Summed across the 3 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238083

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 Ketamine, 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 14 of 53 listed Ketamine NDCs with Medicaid activity.

🔍 Compare Ketamine products

A representative set of FDA-listed product records for Ketamine — 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.)

Showing 88 of 88 products — FDA National Drug Code Directory. See every product, package size and price: browse all 88 Ketamine 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) Ketamine RxCUI 6130 2 dose forms · 4 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 372528 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 238082 50 MG/ML RxCUI 238084 100 MG/ML RxCUI 238083
  2. Dose form (SCDF) Prefilled Syringe RxCUI 2723912 No current FDA listing
    Clinical drug / strength (SCD) 10 ML ketamine 10 MG/ML RxCUI 2723913

Look up RxCUI 6130 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

Ketaset Ketalar

🏭 Manufacturers & labelers

Civica, Inc. 8 Henry Schein, Inc. 8 Hospira, Inc. 7 Par Pharmaceutical, Inc. 6 Fresenius Kabi USA, LLC 6 Gland Pharma Limited 6 Medical Purchasing Solutions, LLC 4 Hikma Pharmaceuticals USA Inc. 4 General Injectables & Vaccines, Inc 4 Mylan Institutional LLC 3 Par Health USA, LLC 3 Henry Schein, Inc 3 Eugia US LLC 3 Sagent Pharmaceuticals 3 AuroMedics Pharma LLC 3 Professional Compounding Centers of America 1 Professional Compounding Centers of America dba PCCA 1 Pharma Source Direct, Inc. 1 Pcas 1 Spectrum Laboratory Products, Inc. 1 Arevipharma GmbH 1 Supriya Lifescience Limited 1 Norchim 1 Medisca Inc. 1

…and 8 more on the FDA NDC directory.

RxNorm drug class

Ketamine belongs to the General Anesthetic class.

Pharmacologic class General Anesthetic
Drug family (ATC) Other general anesthetics

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 Mar 27, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ketamine.
📈
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 Ketamine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
16
NDC products indexed
88
Distinct labelers/manufacturers represented
32
Linked representative label ⓘ
Par Pharmaceutical, Inc.
Linked label effective
Mar 27, 2026
Composite sections available
24
Linked SPL Set ID
14e8f864-8b8a-4e7e-8439-e510d3107063
Linked SPL Document ID
00836cdd-f898-4031-85f8-bb58a63b1a9b
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 16 FDA-filed SPL label sets 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.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. 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. Par Pharmaceutical, Inc. 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.