Dronabinol Recall

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Questions & Answers

Side Effects & Adverse Reactions

Patients receiving treatment with dronabinol capsules should be specifically warned not to drive, operate machinery, or engage in any hazardous activity until it is established that they are able to tolerate the drug and to perform such tasks safely.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Dronabinol capsules are indicated for the treatment of:

  1. anorexia associated with weight loss in patients with AIDS; and

  2. nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.


There is currently no drug history available for this drug.

Other Information

Dronabinol is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol. Dronabinol has the following molecular and structural formulas:


Dronabinol, the active ingredient in dronabinol capsules, is synthetic delta-9-tetrahydrocannabinol (delta-9-THC). Delta-9-tetrahydrocannabinol is also a naturally occurring component of Cannabis sativa L. (Marijuana).

Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.

Capsules for oral administration: Dronabinol capsules are supplied as oblong, soft gelatin capsules containing 2.5 mg, 5 mg or 10 mg dronabinol. Each dronabinol capsule strength is formulated with the following inactive ingredients: FD&C Yellow No. 6, gelatin, glycerin, purified water, sesame oil, titanium dioxide, iron oxide black, shellac glaze, isopropyl alcohol, n-butyl alcohol, propylene glycol, and ammonium hydroxide.  The 2.5 mg and 5 mg also contain FD&C Blue No. 1 and FD&C Red No. 40.

Dronabinol Manufacturers

  • Par Pharmaceutical Inc.
    Dronabinol Capsule [Par Pharmaceutical Inc.]
  • Physicians Total Care, Inc.
    Dronabinol Capsule [Physicians Total Care, Inc.]
  • American Health Packaging
    Dronabinol Capsule [American Health Packaging]
  • Watson Laboratories, Inc.
    Dronabinol Capsule [Watson Laboratories, Inc.]
  • Akorn, Inc.
    Dronabinol Capsule [Akorn, Inc.]
  • Mylan Pharmaceuticals Inc.
    Dronabinol Capsule, Liquid Filled [Mylan Pharmaceuticals Inc.]

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