FDA-filed SPL labeling · retrieved through openFDA

Nabilone

Nabilone is a synthetic cannabinoid used to treat nausea and vomiting caused by cancer chemotherapy when other anti-nausea medications have not worked well enough.

Brand name Cesamet
Drug class Cannabinoid
Rx Schedule CII Form 1 Route Oral
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 effectiveJan 19, 2021
AvailabilityRx
Earliest approval/marketing year 1985
FDA-listed product records 3
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 24, 2026
Nabilone at a glance The quick version — the full detail is in the Patient Information Guide below.
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HelloPharmacist Editorial Team Bottom Line
Nabilone (Cesamet) is a prescription synthetic cannabinoid used specifically for chemotherapy-related nausea and vomiting that hasn't responded to other treatments. It works but comes with significant mental and mood side effects — including the potential for hallucinations, anxiety, and psychosis — and requires close supervision. Because it's a controlled substance with real abuse potential, it's prescribed in limited amounts and should never be combined with alcohol or other sedatives.

📖 Nabilone: Patient Information Guide

A plain-language walkthrough of Nabilone — 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

Nabilone is a synthetic cannabinoid approved for a specific use in cancer care.

  • Cesamet capsules (oral) are approved to treat nausea and vomiting associated with cancer chemotherapy in patients who have not responded adequately to conventional anti-nausea treatments.
  • Cesamet is not a first-line anti-nausea drug — it is reserved for cases where other options have failed.
  • Cesamet is not intended to be used on an as-needed basis; it is used during a defined chemotherapy cycle.
⚙️How it works

Nabilone is a synthetic cannabinoid — meaning it's a lab-made compound that mimics some of the actions of cannabis in the body. It is believed to reduce chemotherapy-induced nausea and vomiting by binding to CB1 receptors (cannabinoid receptors) found in brain and nerve tissue, interrupting the signals that trigger nausea. Beyond its anti-nausea action, it also has broader effects on the central nervous system, producing relaxation, drowsiness, and a sense of euphoria — effects that can be helpful but also carry real risks.

Tolerance to the CNS effects (drowsiness, euphoria) develops quickly and reverses when the drug is stopped. However, psychological dependence is possible with ongoing use.

💊How it's taken

Cesamet capsules are taken by mouth, typically two to three times a day. The first dose is usually given one to three hours before chemotherapy, and a dose the night before chemotherapy may also be recommended. Treatment can continue throughout the chemotherapy cycle and, if needed, for up to 48 hours after the last chemotherapy dose in a cycle.

  • Food does not significantly affect how nabilone is absorbed, so Cesamet can be taken with or without food.
  • Always follow your prescriber's instructions exactly — do not adjust doses on your own.
  • Cesamet is only prescribed in the amount needed for one chemotherapy cycle.
🤒Side effects — in detail

Most people taking Cesamet experience at least one side effect. The most common ones include:

  • Drowsiness or sedation
  • Dizziness or vertigo (a spinning sensation)
  • Dry mouth
  • Feeling "high" or euphoric
  • Balance and coordination problems (ataxia)
  • Difficulty concentrating
  • Headache
  • Sleep disturbances
  • Depression, anxiety, or mood changes
  • Low blood pressure, especially when standing up (orthostatic hypotension)

More serious reactions — including hallucinations, paranoia, confusion, psychosis, or rapid heartbeat — require you to contact your doctor right away. Mental effects can persist for 48 to 72 hours after stopping the medication.

⚠️Warnings & precautions
  • Serious mental effects: Nabilone can cause hallucinations, psychosis, paranoia, anxiety, and mood changes even at recommended doses. These can last up to 72 hours after stopping.
  • Controlled substance / abuse potential: Cesamet is a Schedule II controlled substance with a high potential for abuse and psychological dependence. Patients with a personal or family history of substance abuse are at greater risk.
  • Do not drive or operate machinery while taking Cesamet — it significantly impairs judgment and coordination.
  • Supervision required: A responsible adult should be with you, especially when starting the medication or adjusting doses.
  • Heart effects: Cesamet can increase heart rate (tachycardia) and lower blood pressure, especially when standing up (orthostatic hypotension).
  • No alcohol or sedatives: Combining Cesamet with alcohol, sedatives, or other psychoactive substances greatly increases CNS depression.
🔀What it interacts with

Nabilone interacts with a number of common drugs and substances — always tell your care team everything you take.

  • Alcohol — adds to CNS depression and enhances the euphoric, impairing effects
  • Sedatives, benzodiazepines (e.g., diazepam), sleep aids — greatly increase drowsiness and impair coordination
  • Opioids (e.g., codeine) — additive sedation; mutual potentiation and cross-tolerance can occur
  • Tricyclic antidepressants (e.g., amitriptyline) — can add to increased heart rate, high blood pressure, and drowsiness
  • Stimulants (amphetamines, cocaine) — risk of dangerous increases in heart rate and blood pressure
  • Anticholinergic drugs (atropine, scopolamine, some antihistamines) — increased heart rate and drowsiness
  • Highly protein-bound medications — nabilone may displace them in the bloodstream, potentially altering their effects
  • Theophylline — nabilone may affect how quickly theophylline is metabolized

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 take Cesamet if you have a known allergy to any cannabinoid.
  • Tell your doctor if you or a close family member has a history of substance abuse (including alcohol or drugs) or mental illness.
  • Tell your doctor if you have ever experienced psychosis, severe anxiety, or depression.
  • Tell your doctor about all your medications — especially sedatives, antidepressants, opioids, or anything that causes drowsiness.
  • Avoid alcohol entirely while taking Cesamet.
  • The safety and pharmacokinetics of nabilone in children have not been established — discuss with your doctor before use in pediatric patients.
  • The pharmacokinetic profile of Cesamet in older adults has not been fully studied — use with extra caution and close monitoring.
  • The effects of liver or kidney problems on nabilone's metabolism and clearance are not established — inform your doctor of any organ function concerns.
🚑If you take too much

Taking too much nabilone can cause an extension of its known effects — including hallucinations, severe anxiety, psychotic episodes, rapid heartbeat, low or high blood pressure, respiratory depression, and in extreme cases, coma. If you or someone else may have taken too much, call a Poison Control Center right away or go to the nearest emergency room.

In milder cases of overdose, the label recommends resting in a calm, quiet environment with reassurance and close monitoring, and withholding further doses until the person returns to their normal mental state. Medical teams may use antipsychotic drugs in more severe cases, and monitoring of vital signs, blood pressure, and breathing is essential.

📡Pharmacodynamics — effects in the body

Nabilone acts on the central nervous system through cannabinoid receptors, producing relaxation, drowsiness, and euphoria within its therapeutic dose range. It also increases heart rate and can cause low blood pressure — both when lying down and when standing up (orthostatic hypotension). Dry mouth is another prominent physical effect. Mood changes, altered perception of time and objects, and impaired memory and judgment can also occur, and these effects are more pronounced at higher doses — though psychosis has been reported even at lower doses in some patients.

🔬Pharmacokinetics — how your body processes it

Nabilone is well absorbed when taken by mouth, and food does not significantly affect how much or how quickly the body absorbs it. Blood levels peak within about two hours of a dose. The drug itself has a relatively short half-life of around two hours, but its metabolites (breakdown products) stay in the body much longer — with a half-life of around 35 hours — meaning effects and metabolites can linger well after a dose. Nabilone is extensively broken down by the liver and eliminated mainly through the stool (via the biliary system) and to a lesser extent through urine.

📦How to store it

Store at controlled room temperature 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

📄 Written from Nabilone’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 →

17

Supplements & herbs that interact with Nabilone

17 supplements and herbal products have documented interactions with Nabilone 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
  • Major · 1
  • Moderate · 7
  • Minor · 9
Every supplement checked against Nabilone — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Nabilone 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.

🩺 Pharmacist Counseling Corner

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

Why was I prescribed Cesamet instead of a regular anti-nausea medication?
Cesamet is specifically approved for chemotherapy-related nausea and vomiting that hasn't been controlled well enough by standard anti-nausea drugs. It's not a first-choice option — your doctor prescribed it because other treatments weren't working adequately for you. It works differently from typical anti-nausea medications by targeting cannabinoid receptors in the brain, which is why it can be more effective in certain situations.
Will Cesamet make me feel "high"?
It very possibly can, yes — and it's important to know that going in. Cesamet is a synthetic cannabinoid, and it can cause feelings of euphoria, relaxation, drowsiness, and even altered perception. These effects are more likely at higher doses but can happen at any dose. That's exactly why you need a responsible adult with you, especially at first, and why you absolutely should not drive or operate machinery while taking it.
How long does Cesamet stay in my system, and when do the effects wear off?
Nabilone itself clears relatively quickly, but its breakdown products stay in the body much longer — with some lingering for well over a day. More importantly, the mental and mood effects of Cesamet can last 48 to 72 hours after you stop taking it. So even after your last dose, you should still avoid driving and alcohol and remain supervised until you're confident the effects have fully worn off.
Can I have a glass of wine or a beer while I'm on Cesamet?
No — alcohol and Cesamet are a risky combination. Both depress the central nervous system, and together they can make drowsiness, impaired coordination, and mood effects much worse. The label is clear: avoid alcohol entirely while you're taking this medication. That includes the day or two after your last dose, since the effects of Cesamet can linger.
What side effects should make me call my doctor right away?
Most people experience some drowsiness or dizziness, which is expected. But call your doctor promptly if you experience hallucinations, severe confusion, feelings of paranoia, extreme anxiety or panic, signs of psychosis (feeling disconnected from reality), a very fast heartbeat, or if you feel faint when standing up. These can be serious and your doctor needs to know. Remember — psychiatric reactions can happen even at lower doses.
Is it safe to take Cesamet with my other medications?
It depends on what you're taking. Cesamet can interact with a wide range of medications — including opioid pain relievers, antidepressants, sleep aids, antihistamines, and anything else that causes drowsiness. It can also interact with some heart medications and stimulants. Please share a full list of everything you take — including over-the-counter products and supplements — with your pharmacist and prescriber before starting Cesamet.
Is Nabilone available over the counter?
Nabilone 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 Nabilone a controlled substance?
Yes — Nabilone is a federally controlled substance (Schedule II) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.
When was Nabilone first available?
Nabilone has been available in the United States since at least 1985, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Nabilone?
Nabilone is supplied by 3 manufacturers listed in the FDA NDC Directory, including Bausch Health US LLC, Purisys LLC, Veranova, L.P..

💬 Answers drafted from Nabilone’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 Nabilone comes

Nabilone 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.

Capsule

By mouth
Brands Cesamet
How this form is used
What it may be used for
  • Cesamet capsules are used to treat nausea and vomiting caused by cancer chemotherapy
  • Cesamet is intended only for patients who have not responded adequately to standard anti-nausea medications
Important instructions
  • Cesamet capsules are taken by mouth, typically two to three times a day during a chemotherapy cycle
  • Cesamet's first dose should be taken one to three hours before chemotherapy; a dose the night before may also be helpful
  • Cesamet can be taken with or without food, as food does not significantly affect absorption
  • Cesamet is prescribed only in the amount needed for a single cycle of chemotherapy — do not use it on an as-needed basis
Available strengths 1 strength
1 FDA-listed product record

📊 Nabilone across the U.S. market

How Nabilone 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
3
Manufacturers
1
Brand names
3
FDA-listed product records
1985
First marketed

Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bausch Health US LLC33%
Purisys LLC33%
Veranova, L.P.33%

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

🔍 Compare Nabilone products

A representative set of FDA-listed product records for Nabilone — 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
💊Capsule
1 mg Oral Bausch Health US LLC NDA View NDC →
💊Bulk drug substance
1 kg/kg Purisys LLC BULK INGREDIENT View NDC →
1 kg/kg Veranova, L.P. BULK INGREDIENT View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Nabilone 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) Nabilone RxCUI 31447 1 dose form · 4 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 372975 In current FDA listings
    Clinical drug / strength (SCD) 0.25 MG RxCUI 401975 0.5 MG RxCUI 401974 1 MG RxCUI 311891 2 MG RxCUI 401973

Look up RxCUI 31447 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

Cesamet

🏭 Manufacturers & labelers

Bausch Health US LLC 1 Purisys LLC 1 Veranova, L.P. 1

RxNorm drug class

Nabilone belongs to the Cannabinoid class.

Pharmacologic class Cannabinoid
Drug family (ATC) Other antiemetics

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 Jan 19, 2021
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nabilone.
📈
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 Nabilone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
3
Distinct labelers/manufacturers represented
3
Linked representative label
Bausch Health US LLC
Linked label effective
Jan 19, 2021
Composite sections available
17
Linked SPL Set ID
83c7ac15-ece9-47de-b83c-d575544fa449
Linked SPL Document ID
c8ba6520-445a-4934-85f4-6f706cb21585
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

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.

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. Bausch Health US 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.