Dronabinol Side Effects

Brand Names: Marinol

Please note - some side effects for Dronabinol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Dronabinol - for the Consumer

Dronabinol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dronabinol:

Confusion; decreased coordination; dizziness; drowsiness; elevated or relaxed mood; headache; nausea; stomach pain; trouble concentrating; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; behavioral changes; fast or irregular heartbeat; hallucinations; memory problems; mental or mood changes (eg, feelings of anxiety, depression, detachment, panic, paranoia); seizures; severe or persistent dizziness; vision changes.

Dronabinol Side Effects - for the Professional

Dronabinol

Adverse experiences information summarized in the tables below was derived from well-controlled clinical trials conducted in the U.S. and U.S. territories involving patients exposed to Dronabinol capsules.  Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving Dronabinol and 68 receiving placebo.

A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving Dronabinol capsules in the antiemetic clinical trials.

PROBABLY CAUSALLY RELATED: Incidence greater than 1%.

Rates derived from clinical trials in chemotherapy related nausea (N=317).

Body as a whole: Asthenia.

Cardiovascular: Palpitations, tachycardia, vasodilation/facial flush.

Digestive: Abdominal pain*, nausea*, vomiting*.

Nervous system: (Amnesia), anxiety/nervousness, (ataxia), confusion, depersonalization, dizziness*, euphoria*, (hallucinations), paranoid reaction*, somnolence*, thinking abnormal*.

*Incidence of events 3% to 10%

PROBABLY CAUSALLY RELATED: Incidence less than 1%.

Event rates derived from clinical trials in chemotherapy related nausea (N=317).

Cardiovascular: Conjunctivitis*, hypotension*.

Digestive: Diarrhea*, fecal incontinence.

Musculoskeletal: Myalgias.

Nervous system: Depression, nightmares, speech difficulties, tinnitus.

Skin and Appendages: Flushing*.

Special senses: Vision difficulties.

*Incidence of events 0.3% to 1%

CAUSAL RELATIONSHIP UNKNOWN: Incidence less than 1%.

The clinical significance of the association of these events with Dronabinol capsules treatment is unknown, but they are reported as alerting information for the clinician.

Body as a whole: Chills, headache, malaise.

Digestive: Anorexia, hepatic enzyme elevation.

Respiratory: Cough, rhinitis, sinusitis.

Skin and Appendages: Sweating

Postmarketing Experience

Seizure and seizure-like activity have been reported in patients receiving Dronabinol capsules during marketed use of the drug and in clinical trials. Reports of fatigue have also been received. A causal relationship between Dronabinol capsules and these events has not been established.

Side Effects by Body System

Nervous system

Nervous system side effects have included amnesia, anxiety/nervousness, ataxia, confusion, depersonalization, dizziness, euphoria, hallucination, paranoid reaction, somnolence, seizure, seizure-like activity, and abnormal thinking.

Cardiovascular

Cardiovascular side effects have included palpitations, tachycardia, and vasodilation/facial flush.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, nausea, and vomiting.

General

General side effects have included asthenia and fatigue.

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