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Nitrous oxide

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Active ingredient
Nitrous Oxide 990 mL/1 L
Other brand names
Dosage form
Gas
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2000
Label revision date
November 11, 2025
FDA Insert
Prescribing information, PDF file
Active ingredient
Nitrous Oxide 990 mL/1 L
Other brand names
Dosage form
Gas
Route
Respiratory (inhalation)
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2000
Label revision date
November 11, 2025
Manufacturer
Nitrous Oxide
Registration number
NDA206009
NDC root
54260-001
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Nitrous oxide is a colorless, non-flammable gas that is often used in medical settings for its anesthetic and analgesic (pain-relieving) properties. It is commonly known as "laughing gas" and is typically administered in a controlled environment to help manage pain and anxiety during procedures.

This gas is manufactured by Airgas and is available in a refrigerated liquid form. While the specific mechanism of action is not detailed, nitrous oxide is known to work by affecting the central nervous system, providing a calming effect and reducing discomfort.

Uses

Nitrous Oxide is commonly used as both an anesthetic and an analgesic agent. This means it helps to relieve pain and induce a state of unconsciousness during medical procedures. It is often utilized in various settings, including dental work and surgeries, to ensure that you remain comfortable and pain-free.

While there are no specific teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects mentioned, it's always important to discuss any concerns with your healthcare provider before undergoing treatment.

Dosage and Administration

To use this medication, you will inhale it through your respiratory system. The active ingredient in this treatment is nitrous oxide, which is provided in a concentration of 990 mL within a 1-liter container.

Make sure to follow the instructions provided by your healthcare professional regarding how to properly inhale the medication. This method of administration is designed to deliver the medication effectively to help you. Always consult with your doctor if you have any questions about how to use it or if you need further clarification on the process.

What to Avoid

It seems that the information provided does not specify any particular contraindications, controlled substance details, risks of abuse or misuse, or concerns about dependence. Additionally, there are no explicit "do not take" or "do not use" instructions mentioned.

If you have any specific questions or need guidance on a particular aspect of the medication, please feel free to ask! It's important to consult with a healthcare professional for personalized advice and to ensure safe use of any medication.

Side Effects

You may experience a range of side effects while using this medication. Common reactions include dizziness, nausea, vomiting, headache, and a feeling of euphoria. Some people may also experience less common effects such as hallucinations, anxiety, confusion, or drowsiness.

Serious side effects can occur, including hypoxia (low oxygen levels), respiratory depression (slowed breathing), and cardiovascular issues like low blood pressure or slow heart rate. Rarely, you might encounter neurological effects, hematological issues (like megaloblastic anemia), or allergic reactions, which can include rashes or hives. It's important to note that there have been reports of severe allergic reactions, including anaphylaxis (a life-threatening allergic response), as well as concerns about abuse and dependence, especially in individuals with a history of substance misuse. Prolonged use may also lead to vitamin B12 deficiency.

Warnings and Precautions

It's important to stay informed about your health and any medications you may be taking. While there are no specific warnings or precautions listed for this medication, it's always a good idea to monitor how you feel and report any unusual symptoms to your healthcare provider.

If you experience any concerning side effects or have questions about your treatment, don't hesitate to reach out to your doctor. They can provide guidance tailored to your individual health needs. Remember, your well-being is a priority, and open communication with your healthcare team is key.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when in doubt, it’s better to err on the side of caution and seek assistance.

Pregnancy Use

It’s important to be cautious about the use of nitrous oxide during pregnancy. The safety and effectiveness of this substance for pregnant individuals have not been established, and there is a potential risk to the developing fetus. Because of this, nitrous oxide is generally not recommended for use during pregnancy.

If you are pregnant or planning to become pregnant, it’s crucial to discuss any potential treatments with your healthcare provider. They can help you weigh the potential benefits against the risks to ensure the best outcome for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of nitrous oxide while nursing. Additionally, the information available does not indicate any concerns about nitrous oxide being present in breast milk or affecting your milk production. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

Currently, there is no specific information available regarding the use of this medication in children. This means that there are no recommended ages, dosage differences, or safety concerns outlined for pediatric patients (children). If you are considering this medication for a child, it is essential to consult with a healthcare professional to ensure it is appropriate and safe for their specific needs. Always prioritize your child's health and well-being by seeking expert advice.

Geriatric Use

As you age, your body may respond differently to medications, including nitrous oxide. Older adults often have increased sensitivity to its effects, which means you might experience stronger reactions than younger individuals. It's also important to consider that kidney function can decline with age, potentially affecting how your body processes medications.

Because of these factors, your healthcare provider may recommend adjusting the dosage of nitrous oxide for you. These adjustments help ensure that you receive the safest and most effective treatment tailored to your needs. Always discuss any concerns or questions with your doctor to ensure your care is appropriate for your age and health status.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific situation. They can help determine the best approach for managing your health while considering your kidney function.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always discuss your full list of medications, including over-the-counter drugs and supplements, as well as any upcoming lab tests. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Avoid exposing the product to heat or flame, and do not freeze it, as extreme temperatures can affect its effectiveness.

If you open the container and do not use the product, please discard it to maintain safety and quality. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Nitrous Oxide used for?

Nitrous Oxide is used as an anesthetic and analgesic agent.

How is Nitrous Oxide administered?

Nitrous Oxide is administered via inhalation through the respiratory route.

What are the common side effects of Nitrous Oxide?

Common adverse reactions include dizziness, nausea, vomiting, headache, and euphoria.

What serious side effects should I be aware of?

Serious side effects may include hypoxia, respiratory depression, and cardiovascular effects such as hypotension and bradycardia.

Is Nitrous Oxide safe to use during pregnancy?

The safety and efficacy of Nitrous Oxide during pregnancy have not been established, and it is contraindicated due to potential risks to the fetus.

What precautions should be taken for elderly patients using Nitrous Oxide?

Elderly patients may have increased sensitivity to Nitrous Oxide, and dosage adjustments may be necessary due to age-related physiological changes.

How should Nitrous Oxide be stored?

Store Nitrous Oxide in a cool, dry place, protect it from light, and keep the container tightly closed when not in use.

Packaging Info

The table below lists all NDC Code configurations of Nitrous Oxide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nitrous Oxide.
Details

FDA Insert (PDF)

This is the full prescribing document for Nitrous Oxide, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

Nitrous Oxide is indicated for use as an anesthetic and analgesic agent in various medical procedures. This drug provides effective sedation and pain relief, making it suitable for use in both surgical and non-surgical settings.

Limitations of Use: There are no specific teratogenic or nonteratogenic effects associated with Nitrous Oxide as per the available data. However, healthcare professionals should exercise caution and consider individual patient circumstances when administering this agent.

Dosage and Administration

Nitrous oxide is administered via inhalation through the respiratory route. The recommended strength for administration is 990 mL of nitrous oxide in a 1 L volume.

Healthcare professionals should ensure that the nitrous oxide is delivered using appropriate inhalation equipment designed for respiratory use. The administration should be performed in a controlled environment, with monitoring of the patient’s response throughout the procedure.

It is essential to follow institutional protocols regarding the frequency and duration of inhalation, adjusting as necessary based on the clinical situation and patient response.

Contraindications

There are no specified contraindications for the use of this product. Healthcare professionals should exercise clinical judgment when considering its use in patients with potential risk factors or underlying conditions.

Warnings and Precautions

There are currently no specific warnings or general precautions associated with the use of this medication. Additionally, no laboratory tests have been identified as necessary for monitoring during treatment.

Healthcare professionals should remain vigilant and assess the patient's overall health status regularly. In the absence of specific emergency medical instructions, it is advisable to maintain open communication with patients regarding any unusual symptoms or concerns that may arise during the course of treatment.

Should any adverse effects or unexpected reactions occur, healthcare providers are encouraged to evaluate the situation promptly and consider appropriate interventions.

Side Effects

Serious adverse reactions associated with the use of this medication include hypoxia, respiratory depression, and cardiovascular effects such as hypotension and bradycardia. These serious side effects necessitate careful monitoring of patients, particularly those with pre-existing conditions that may exacerbate these risks.

Common adverse reactions reported in clinical trials include dizziness, nausea, vomiting, headache, and euphoria. These effects were frequently observed among participants and may impact the overall tolerability of the treatment.

Less common adverse reactions include hallucinations, anxiety, confusion, and drowsiness. While these reactions are not as prevalent, they warrant attention, especially in patients who may be sensitive to central nervous system effects.

Rare adverse reactions have also been documented, including neurological effects such as peripheral neuropathy, hematological effects like megaloblastic anemia, and allergic reactions, which may manifest as rash or urticaria.

Postmarketing experience has revealed reports of abuse and dependence, highlighting the importance of assessing patients' histories, particularly those with a history of substance abuse, as they may be at an increased risk of misuse. Additionally, severe allergic reactions, including anaphylaxis, have been reported, necessitating immediate medical attention.

It is important to note that prolonged exposure to this medication may lead to vitamin B12 deficiency, which should be monitored in patients receiving long-term treatment.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Nitrous Oxide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nitrous Oxide.
Details

Pediatric Use

There is no specific pediatric use information, including recommended ages, dosing differences, safety concerns, or special precautions for children, provided in the prescribing information. Therefore, healthcare professionals should exercise caution when considering the use of this medication in pediatric patients, as the safety and efficacy in this population have not been established.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the effects of nitrous oxide. This heightened sensitivity necessitates careful monitoring and consideration when administering the agent to this population.

Additionally, it is important to take into account the potential for reduced kidney function in geriatric patients. Age-related physiological changes can impact drug metabolism and excretion, which may warrant dosage adjustments to ensure safety and efficacy.

Healthcare providers should remain vigilant in assessing the individual needs of elderly patients, as these factors can significantly influence treatment outcomes.

Pregnancy

The safety and efficacy of nitrous oxide during pregnancy have not been established. There is a potential risk to the fetus, and nitrous oxide is contraindicated in pregnancy. Use during pregnancy should be avoided unless the potential benefits justify the potential risks to the fetus. Healthcare professionals are advised to carefully consider the implications of nitrous oxide administration in pregnant patients and to explore alternative options when possible.

Lactation

There are no specific warnings or recommendations regarding the use of nitrous oxide in lactating mothers. Additionally, there are no considerations or precautions related to lactation or the potential for excretion of nitrous oxide in breast milk.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as required.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be informed that nitrous oxide is utilized for the relief of pain and anxiety during medical procedures. It is essential for patients to communicate with their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding, as this information may influence the use of nitrous oxide.

Healthcare providers should counsel patients on the potential side effects associated with nitrous oxide, which may include dizziness, nausea, and headache. Patients should be instructed to avoid operating heavy machinery or driving after receiving nitrous oxide until they are fully recovered, as their ability to perform such tasks may be impaired.

Additionally, patients should be made aware that they may experience feelings of euphoria or lightheadedness while using nitrous oxide. It is important for patients to report any unusual or severe side effects to their healthcare provider immediately to ensure their safety and well-being.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to protect the product from light exposure and to keep the container tightly closed when not in use. The product should not be exposed to heat or flame, and freezing is strictly prohibited. Any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Nitrous Oxide as submitted by Nitrous Oxide. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Nitrous Oxide, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (NDA206009) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.