Marinol Side Effects
Generic Name: dronabinol
Please note - some side effects for Marinol 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 Marinol - for the Consumer
Marinol
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 Marinol:
Seek medical attention right away if any of these SEVERE side effects occur when using Marinol:Confusion; decreased coordination; dizziness; drowsiness; elevated or relaxed mood; headache; nausea; stomach pain; trouble concentrating; vomiting; weakness.
TopSevere 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.
Marinol Side Effects - for the Professional
Marinol
Adverse experiences information summarized in the tables below was derived from well-controlled clinical trials conducted in the US and US territories involving 474 patients exposed to Marinol Capsules. Studies of AIDS-related weight loss included 157 patients receiving dronabinol at a dose of 2.5 mg twice daily and 67 receiving placebo. Studies of different durations were combined by considering the first occurrence of events during the first 28 days. 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 Marinol Capsules in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%).
The most frequently reported adverse experiences in patients with AIDS during placebo-controlled clinical trials involved the CNS and were reported by 33% of patients receiving Marinol Capsules. About 25% of patients reported a minor CNS adverse event during the first 2 weeks and about 4% reported such an event each week for the next 6 weeks thereafter.
PROBABLY CAUSALLY RELATED: Incidence greater than 1%.
Rates derived from clinical trials in AIDS-related anorexia (N=157) and chemotherapy-related nausea (N=317). Rates were generally higher in the anti-emetic use (given in parentheses).
| *Incidence of events 3% to 10% |
| 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*, (hallucination), paranoid reaction*, somnolence*, thinking abnormal*. |
PROBABLY CAUSALLY RELATED: Incidence less than 1%.
Event rates derived from clinical trials in AIDS-related anorexia (N=157) and chemotherapy-related nausea (N=317).
| *Incidence of events 0.3% to 1% |
| Cardiovascular: Conjunctivitis*, hypotension*. Digestive: Diarrhea*, fecal incontinence. Musculoskeletal: Myalgias. Nervous system: Depression, nightmares, speech difficulties, tinnitus. Skin and Appendages: Flushing*. Special senses: Vision difficulties. |
CAUSAL RELATIONSHIP UNKNOWN: Incidence less than 1%.
The clinical significance of the association of these events with Marinol 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 Marinol Capsules during marketed use of the drug and in clinical trials. Reports of fatigue have also been received. A causal relationship between Marinol Capsules and these events has not been established.
TopSide 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.
TopMore resources:
Marinol - Includes detailed dosage instructions.
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