FDA Approves Marinol (dronabinol) for AIDS-Related Anorexia and Chemotherapy-Induced Nausea/Vomiting

FDA Published March 31, 2026 DOI ↗

Key Takeaway

Consider for AIDS-related anorexia or chemo-induced nausea/vomiting after conventional treatments fail.

The FDA has approved Marinol (dronabinol), a cannabinoid, for use in adults with two distinct clinical presentations. The drug is indicated for the treatment of anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). It is also approved for the management of nausea and vomiting associated with cancer chemotherapy, specifically for patients who have not responded adequately to conventional antiemetic treatments. This approval provides clinicians with an additional therapeutic option for these challenging conditions where standard care may be insufficient. The drug's approval is based on clinical studies that established its effectiveness for these specific patient populations. Dosing and administration differ between the two indications, with specific titration schedules to manage dose-related central nervous system adverse reactions.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Not reported in label.

Indication & Patient Population

MARINOL is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS); and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Dosing & Administration

For anorexia in AIDS: The recommended adult starting dosage is 2.5 mg orally twice daily, one hour before lunch and dinner. In elderly or intolerant patients, consider 2.5 mg once daily before dinner or at bedtime. Dosage may be titrated gradually; maximum dosage is 10 mg twice daily. For chemotherapy-induced nausea/vomiting: The recommended starting dosage is 5 mg/m² orally 1 to 3 hours prior to chemotherapy, then every 2 to 4 hours after, for 4 to 6 doses/day. In elderly patients, consider 2.5 mg/m² once daily prior to chemotherapy. Administer first dose on an empty stomach. Dosage can be titrated; maximum dosage is 15 mg/m² per dose for 4 to 6 doses/day.

Key Clinical Trial Data

The effectiveness was established based on studies for both indications. For appetite stimulation in AIDS, a randomized, double-blind, placebo-controlled study involved 139 patients. The initial dosage was 5 mg/day (2.5 mg before lunch and dinner). Side effects (feeling high, dizziness, confusion, somnolence) occurred in 13 of 72 patients (18%) at this dosage, leading to a reduction to 2.5 mg/day. Of 112 patients completing at least 2 visits, 99 had appetite data at 4-weeks (50 received MARINOL, 49 placebo). Trial data for chemotherapy-induced nausea/vomiting not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

MARINOL is indicated for anorexia in AIDS patients and for nausea/vomiting in cancer chemotherapy patients who have failed to respond adequately to conventional antiemetic treatments.

The U.S. Food and Drug Administration (FDA) has approved a new prescription medicine called Marinol. Its active ingredient is dronabinol, which is a type of cannabinoid. The drug is approved to treat two specific problems in adults. First, it is for treating a lack of appetite and the serious weight loss that can happen in people with AIDS. Second, it is for managing the nausea and vomiting caused by cancer chemotherapy, but only for patients whose nausea has not gotten better enough with standard anti-nausea treatments.

This approval is important because it gives doctors another tool to help patients who are struggling with these challenging side effects of their illnesses or treatments. The FDA based its decision on clinical studies that showed Marinol was effective for these specific groups of people. The dose a patient takes is different depending on whether it is for AIDS-related weight loss or for chemotherapy nausea, and doctors will adjust it carefully.

It is important to know that Marinol is not for everyone. It is specifically for the two conditions mentioned and for patients who meet certain criteria. Like all medicines, it can have side effects, which can include effects on the brain and nervous system. The approval means the drug has been found safe and effective for its intended uses, but it is still a powerful prescription medication.

If you or someone you care for has AIDS with severe weight loss or is dealing with chemotherapy nausea that other treatments haven't helped, this news might be relevant. The most important step is to have a conversation with the treating doctor. They can explain if Marinol could be a suitable option based on an individual's specific health situation and overall care plan.

What this means for you: This is a new FDA-approved option for specific, severe cases of weight loss in AIDS and hard-to-treat chemo nausea.

View Original Abstract ↓

1 INDICATIONS & USAGE MARINOL is 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. MARINOL 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.