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Nitrous oxide

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Active ingredient
Nitrous Oxide 900 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 900 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 of Canada
Registration number
NDA206009
NDC root
72343-001
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 reduce anxiety and discomfort during medical procedures.

In addition to its use in healthcare, nitrous oxide is also utilized in various industrial applications. It is important to note that nitrous oxide should only be used under professional supervision to ensure safety and effectiveness.

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's often utilized in various settings, including dental work and surgeries, to ensure that you remain comfortable and pain-free.

While there are no specific concerns regarding teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus), it's always important to discuss any potential risks with your healthcare provider, especially if you are pregnant or planning to become pregnant.

Dosage and Administration

When using this medication, you will be inhaling nitrous oxide, which is a gas that helps with pain relief and sedation. The medication comes in a container that holds 900 mL of nitrous oxide in a total volume of 1 liter.

To take the medication, you will need to inhale it through your respiratory system. This means you will breathe it in, allowing it to enter your lungs and take effect. Make sure to follow the specific instructions provided by your healthcare provider regarding how often you should use it.

What to Avoid

It seems that the information regarding what to avoid while using this medication is not specified in the provided text. Therefore, I recommend consulting your healthcare provider or the medication's official guidelines for detailed information on contraindications, controlled substance classification, risks of abuse or misuse, dependence concerns, and specific instructions on when not to take or use the medication. Your safety and well-being are important, so please ensure you have all the necessary information before proceeding.

Side Effects

Using nitrous oxide may lead to some side effects, which can vary in severity. Common reactions include dizziness, nausea, vomiting, headache, and sedation. More serious effects can occur, such as hypoxia (low oxygen levels), respiratory depression (slowed breathing), cardiovascular issues like low blood pressure or slow heart rate, and neurological problems, including peripheral neuropathy (nerve damage) and myeloneuropathy (spinal cord damage).

It's important to be aware that nitrous oxide has a potential for abuse and dependence. Additionally, allergic reactions, increased pressure in the brain, and a risk of vitamin B12 deficiency with long-term use have been noted. After stopping nitrous oxide, some people may experience diffusion hypoxia, which is a temporary drop in oxygen levels. If you experience any concerning symptoms, please consult a healthcare professional.

Warnings and Precautions

It seems that the specific warnings, precautions, and instructions for emergency help or stopping use of the medication were not provided in the information available. Therefore, I cannot offer detailed guidance on these important aspects.

If you have any concerns about a medication or need specific information regarding its use, please consult your healthcare provider or pharmacist. They can provide you with the necessary details and support to ensure your safety and well-being.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you or someone else may have taken too much of the medication, seek immediate medical help. You can call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risk of overdose.

Pregnancy Use

It’s important to be aware that the safety and effectiveness of nitrous oxide during pregnancy have not been established. There is a potential risk to your developing baby, which is why nitrous oxide is generally not recommended for use during pregnancy.

If you are in labor or delivery, the use of nitrous oxide should be approached with caution, as it may have effects on your fetus. Always discuss any pain management options with your healthcare provider to ensure the best care 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. The information available does not indicate any particular considerations or precautions you need to take during lactation (the period when you are producing milk for your baby).

As always, if you have any concerns or questions about medications and breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

Currently, there is no specific information available regarding the use of nitrous oxide in children. This means that there are no recommended ages, dosage differences, or safety concerns outlined for pediatric use. If you are considering nitrous oxide for your child, it is important to consult with a healthcare professional to discuss any potential risks and to ensure that it is appropriate for their specific situation. Always prioritize your child's safety and well-being when making decisions about their healthcare.

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 condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a refrigerated liquid state. It's important to keep the cylinder upright to prevent any leaks or damage. Additionally, make sure to protect the product from light, as exposure can affect its quality. Following these guidelines will help maintain the integrity of the device and ensure it functions as intended.

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 adverse reactions to Nitrous Oxide?

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

What serious adverse reactions can occur with Nitrous Oxide?

Serious adverse reactions may include hypoxia, respiratory depression, cardiovascular effects, and neurological effects.

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.

Are there any precautions 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.

What should I do if I experience adverse reactions?

If you experience adverse reactions, you should seek medical attention immediately.

How should Nitrous Oxide be stored?

Nitrous Oxide should be stored in a refrigerated liquid state, kept upright, and protected from light.

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 mentioned in the available data. Therefore, healthcare professionals should consider the absence of documented teratogenic effects when evaluating its use in pregnant patients, while also adhering to standard clinical guidelines and practices.

Dosage and Administration

Nitrous oxide is administered via inhalation through the respiratory route. The recommended strength for administration is 900 mL of nitrous oxide in a total volume of 1 liter.

Healthcare professionals should ensure that the nitrous oxide is delivered using appropriate inhalation equipment designed for respiratory use. It is essential to monitor the patient throughout the administration process to ensure safety and efficacy.

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

Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.

It is essential to monitor patients closely for any adverse reactions or complications that may arise during treatment. Regular laboratory tests may be necessary to assess the patient's response to therapy and to ensure safety. Specific parameters for monitoring should be established based on the individual patient's health status and the medication's profile.

In the event of severe side effects or unexpected reactions, immediate medical attention should be sought. Healthcare providers should instruct patients to discontinue use and contact their physician if they experience any concerning symptoms.

Overall, vigilance in monitoring and patient education regarding the signs of potential complications are crucial for the safe administration of this medication.

Side Effects

Nitrous oxide has the potential for abuse and dependence, which is highlighted in the boxed warning.

Common adverse reactions observed in patients include dizziness, nausea, vomiting, headache, and sedation. These reactions are frequently reported and may vary in intensity among individuals.

Serious adverse reactions have also been noted, including hypoxia, respiratory depression, and cardiovascular effects such as hypotension and bradycardia. Neurological effects, including peripheral neuropathy and myeloneuropathy, have been documented as well.

Additional adverse reactions of clinical significance include allergic reactions, such as anaphylaxis, and increased intracranial pressure. Prolonged use of nitrous oxide may lead to vitamin B12 deficiency, necessitating monitoring in long-term users. Furthermore, there is a risk of diffusion hypoxia following the discontinuation of nitrous oxide, which should be considered in the management of patients.

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

Pediatric use of nitrous oxide has not been specifically detailed in the available information. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for children provided in the prescribing information. Therefore, healthcare professionals should exercise caution and consider the lack of specific pediatric data when administering nitrous oxide to pediatric patients.

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 account for the potential for reduced kidney function in geriatric patients, which may impact the pharmacokinetics and overall safety profile of the treatment.

Due to age-related physiological changes, dosage adjustments may be required for elderly patients to ensure optimal therapeutic outcomes while minimizing the risk of adverse effects. Healthcare providers should assess each patient's individual health status and renal function when determining the appropriate dosage.

Pregnancy

The safety and efficacy of nitrous oxide during pregnancy have not been established. There is a potential risk to the fetus, and therefore, nitrous oxide is contraindicated in pregnancy. The use of nitrous oxide during labor and delivery should be carefully considered, as it may have potential effects on fetal outcomes. Healthcare professionals are advised to weigh the risks and benefits before administering nitrous oxide to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of nitrous oxide in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided information. Therefore, healthcare professionals may consider the use of nitrous oxide in nursing mothers without specific concerns related to breastfeeding.

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 the use of this medication. Consequently, there are no 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 significantly 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, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or specific treatments should be administered as indicated. Continuous monitoring of the patient’s condition is crucial, and further interventions may be required based on the evolving clinical picture.

It is advisable for healthcare professionals to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, ensuring that the most effective and evidence-based treatment strategies are employed.

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 these contexts.

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 important 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.

Patients should be counseled regarding the potential side effects associated with nitrous oxide, which may include dizziness, nausea, and headache. They should be instructed to avoid operating heavy machinery or driving after receiving nitrous oxide until they are fully recovered, as the effects of the medication can impair their ability to perform these tasks safely.

Additionally, patients should be made aware that they may experience feelings of euphoria or lightheadedness while using nitrous oxide. It is crucial for patients to report any unusual or severe reactions to their healthcare provider immediately, ensuring that any adverse effects are addressed promptly.

Storage and Handling

The product is supplied in a refrigerated liquid state and must be stored in an upright position to maintain its integrity. It is essential to protect the product from light exposure to ensure optimal stability 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 of Canada. 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.