Prescription medicine
Dronabinol Brand names: Marinol, Syndros
Dronabinol (Marinol) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $3.35 per dronabinol 5 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- DEA Schedule II
Check it at the source: the dronabinol FDA label on DailyMed (effective May 6, 2026, Ascend Laboratories, LLC); the NDA 18651 record on Drugs@FDA; every dronabinol label on DailyMed.
Highlights of the record
FDA label of May 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDronabinol capsules are indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS).
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 5 mg/ml
Capsule; solution.
On the market
- Earliest approval on file
- May 31, 1985 Marinol, Alkem Labs Ltd; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first June 27, 2008; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 1 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- August 6, 2028 Syndros oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $3.35 per capsule Dronabinol 5 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,995 through July 30, 2026
What is dronabinol used for?
From the label: indications and usageDronabinol capsules are indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol capsules is a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS. ( 1 ) Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
FDA pharmacologic class: Cannabinoid.
Source: FDA drug label (Dronabinol), NDA018651 (Alkem Labs Ltd), as published by Ascend Laboratories, LLC, effective May 6, 2026 (SPL set adb1801c-0fb5-4e16-b969-1db91230e0b9), via openFDA; the full label on DailyMed
What does the patient leaflet for dronabinol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SYNDROS?SYNDROS can cause serious side effects, including: Worsening mental (psychiatric) symptoms. Psychiatric symptoms can worsen in people who have mania, depression, or schizophrenia and who take SYNDROS. SYNDROS taken with medicines that cause psychiatric symptoms can worsen psychiatric symptoms. Elderly people who take SYNDROS may have a greater risk of having psychiatric symptoms. Tell your doctor if you have new or worsening mood symptoms, including symptoms of mania, depression, or schizophrenia. Problems thinking clearly. Tell your doctor if you have trouble remembering things, concentrating, have increased sleepiness, or confusion. Elderly people may have a greater risk of having problems thinking clearly. Changes in your blood pressure. SYNDROS may increase or decrease your blood pressure, especially when you start taking SYNDROS or when your dose is changed. Tell your doctor if you have signs or symptoms of changes in your blood pressure including: headaches, vision problems, dizziness, feeling lightheaded, fainting, or a fast heartbeat. Elderly people, especially those with dementia, and people with heart problems may have an increased risk of changes in blood pressure and an increased risk of falls. Interactions with disulfiram or metronidazole. SYNDROS contains alcohol, which can cause you to have a reaction to medicines that contain disulfiram or metronidazole. You should not use any medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) if you take SYNDROS. You should not use a medicine that contains disulfiram or metronidazole for at least 14 days before you start taking SYNDROS and within 7 days after your last dose of SYNDROS. […]
From the patient leaflet: What should I avoid while taking SYNDROS?Do not drive, operate machinery, or do other dangerous activities until you know how SYNDROS affects you. SYNDROS taken with medicines that cause dizziness, confusion, and sleepiness may make these symptoms worse.
Source: FDA drug label (SYNDROS), Wellhouse Pharma, LLC, effective April 17, 2026 (SPL set 3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89), via openFDA; the full label on DailyMed
Is there a generic for dronabinol (Marinol)?
The FDA approved the first generic dronabinol on June 27, 2008. 5 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dronabinol from 1 labeler under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Marinol capsules; a patent listed only for Syndros oral solution runs to August 6, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1985 earliest approval on file
- 2008 first generic approved
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dronabinol (Marinol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.35 per Dronabinol 5 mg capsule, up 13% from $2.96 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dronabinol 5 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dronabinol 5 mg capsule | Generic | $3.35 per capsule | $100.61 | +13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the dronabinol label say about other medicines?
The dronabinol label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name dronabinol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Monitor for potentially increased dronabinol-related adverse reactions when dronabinol capsules are co-administered with inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) and inhibitors of CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice). |
| Amitriptyline | warnings and precautions | Avoid concomitant use of other drugs that are also associated with similar cardiac effects (e.g., amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, other tricyclic antidepressants). |
| Amoxapine | warnings and precautions | Avoid concomitant use of other drugs that are also associated with similar cardiac effects (e.g., amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, other tricyclic antidepressants). |
| Amphotericin b | drug interactions | Potential for displacement of other drugs from plasma proteins; monitor for adverse reactions to concomitant highly protein-bound drugs and narrow therapeutic index drugs (e.g., warfarin, cyclosporine, amphotericin B) when initiating or increasing the dosage of dronabinol capsules. |
| Atropine | warnings and precautions | Avoid concomitant use of other drugs that are also associated with similar cardiac effects (e.g., amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, other tricyclic antidepressants). |
| Buspirone | warnings and precautions | Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants may increase this effect (e.g., barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants). |
| Clarithromycin | drug interactions | Monitor for potentially increased dronabinol-related adverse reactions when dronabinol capsules are co-administered with inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) and inhibitors of CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice). |
| Cyclosporine | drug interactions | Potential for displacement of other drugs from plasma proteins; monitor for adverse reactions to concomitant highly protein-bound drugs and narrow therapeutic index drugs (e.g., warfarin, cyclosporine, amphotericin B) when initiating or increasing the dosage of dronabinol capsules. |
| Dehydrated alcohol | contraindications | SYNDROS contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol. |
| Desipramine | warnings and precautions | Avoid concomitant use of other drugs that are also associated with similar cardiac effects (e.g., amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, other tricyclic antidepressants). |
| Disulfiram | drug interactions | Disulfiram and Metronidazole SYNDROS contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol, which can produce disulfiram-like reactions when co-administered with disulfiram or other drugs that produce this reaction (e.g., metronidazole). |
| Erythromycin | drug interactions | Monitor for potentially increased dronabinol-related adverse reactions when dronabinol capsules are co-administered with inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) and inhibitors of CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice). |
| Fluconazole | drug interactions | Monitor for potentially increased dronabinol-related adverse reactions when dronabinol capsules are co-administered with inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) and inhibitors of CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice). |
| Itraconazole | drug interactions | Monitor for potentially increased dronabinol-related adverse reactions when dronabinol capsules are co-administered with inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) and inhibitors of CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice). |
Every other medicine the dronabinol label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | … (e.g., amiodarone, fluconazole) and inhibitors of CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice). |
| Lithium | warnings and precautions | … increase this effect (e.g., barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle … |
| Metronidazole | drug interactions | Disulfiram and Metronidazole SYNDROS contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol, which can produce disulfiram-like reactions when co-administered with disulfiram or other … |
| Ritonavir | drug interactions | … CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice). |
| Scopolamine | warnings and precautions | … barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants). |
| Warfarin | drug interactions | … highly protein-bound drugs and narrow therapeutic index drugs (e.g., warfarin, cyclosporine, amphotericin B) when initiating or increasing the dosage of dronabinol capsules. |
Source: FDA drug label (Dronabinol), NDA018651 (Alkem Labs Ltd), as published by Ascend Laboratories, LLC, effective May 6, 2026 (SPL set adb1801c-0fb5-4e16-b969-1db91230e0b9), via openFDA; the full label on DailyMed
What do FAERS reports show for dronabinol?
The FDA Adverse Event Reporting System holds 7,995 reports that list dronabinol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,672 are coded as a death and 3,105 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Dronabinol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other