Medical Editor: John P. Cunha, DO, FACOEP
Marinol (dronabinol) is a cannabinoid, a man-made form of cannabis (marijuana is an herbal form of cannabis), used to treat loss of appetite in people with AIDS, and to treat severe nausea and vomiting caused by cancer chemotherapy. Marinol is used only when other medications are unable to control the nausea and vomiting. Marinol is available in generic form. Common side effects of Marinol include:
- mood changes,
- trouble concentrating,
- feeling "high,"
- warmth or tingly feeling,
- an exaggerated sense of well-being,
- red eyes,
- dry mouth,
- stomach or abdominal pain,
- sleep problems (insomnia),
- lack of coordination,
- weakness, or
Tell your doctor if you have serious side effects of Marinol including:
- fast heart rate or pounding heartbeat,
- seizure (convulsions),
- unusual thoughts or behavior, or
- mental/mood changes (such as nervousness, hallucinations, abnormal thoughts, extreme fear, or paranoia).
For appetite stimulation the initial dose of Marinol is 2.5 mg taken orally twice daily. For nausea and vomiting, the initial dose of Marinol is 5 mg/m2, given 1 to 3 hours prior to the administration of chemotherapy, then every 2 to 4 hours after chemotherapy is given, for a total of 4 to 6 doses/day. Marinol may interact with sedatives, barbiturates, amphetamines, stimulants and medicine to treat attention deficit hyperactivity disorder (ADHD), prescription or over-the-counter weight loss aids, antidepressants, lithium, theophylline, buspirone, atropine, belladonna, dicyclomine, clidinium, glycopyrrolate, hyoscyamine, mepenzolate, methscopolamine, scopolamine, methantheline, propantheline, or street drugs such as cocaine or Ectasy. Tell your doctor all medications you use. Marinol is not recommended for use during pregnancy because of possible fetus/infant harm reported with marijuana exposure (Marinol contains the active substance found in marijuana). This drug passes into breast milk. Breastfeeding is not recommended while using this drug. Marinol may be habit-forming and you may experience withdrawal symptoms if this medication is stopped abruptly.
Our Marinol (dronabinol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using dronabinol and call your doctor at once if you have any of these serious side effects:
- seizure (convulsions);
- paranoia, extreme fear;
- fast heart rate;
- feeling light-headed, fainting; or
- unusual thoughts or behavior.
Continue using dronabinol and talk with your doctor if you have any of these less serious side effects:
- mood changes;
- dizziness, trouble concentrating;
- feeling "high";
- weakness, lack of coordination;
- anxiety, confusion;
- stomach pain, nausea, vomiting, diarrhea;
- warmth or tingly feeling; or
- sleep problems (insomnia).
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Marinol (Dronabinol Capsules)
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following serious adverse reactions are described below and elsewhere in the labeling.
- Neuropsychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Hemodynamic Instability [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Paradoxical Nausea, Vomiting, and Abdominal Pain [see WARNINGS AND PRECAUTIONS]
Studies of AIDS-related weight loss included 157 patients receiving MARINOL at a dose of 2.5 mg twice daily and 67 receiving placebo. Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving MARINOL and 68 receiving placebo. In the tables below is a summary of the adverse reactions in 474 patients exposed to MARINOL in studies.
Studies of different durations were combined by considering the first occurrence of events during the first 28 days.
A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving MARINOL 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. About 25% of patients reported a CNS adverse reaction during the first 2 weeks and about 4% reported such a reaction each week for the next 6 weeks thereafter.
Common Adverse Reactions
The following adverse reactions were reported in clinical trials at an incidence greater than 1%.
|System Organ Class||Adverse Reactions|
|Cardiovascular||Palpitations, tachycardia, vasodilation/facial flush|
|Gastrointestinal||Abdominal pain*, nausea*, vomiting*|
|Central Nervous System||Dizziness*, euphoria*, paranoid reaction*, somnolence*, thinking abnormal*, amnesia, anxiety/nervousness, ataxia, confusion, depersonalization, hallucination|
|* Actual incidence 3% to 10%|
Less Common Adverse Reactions
The following adverse reactions were reported in clinical trials at an incidence less than or equal to 1%.
|System Organ Class||Adverse Reactions|
|General||Chills, headache, malaise|
|Cardiovascular||Hypotension, conjunctival injection [see CLINICAL PHARMACOLOGY]|
|Gastrointestinal||Diarrhea, fecal incontinence, anorexia, hepatic enzyme elevation|
|Central Nervous System||Depression, nightmares, speech difficulties, tinnitus|
|Respiratory||Cough, rhinitis, sinusitis|
The following adverse reactions have been identified during post-approval use of dronabinol capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General disorders and administration site conditions: Fatigue
Hypersensitivity reactions: Lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see CONTRAINDICATIONS]
Injury, poisoning and procedural complications: Fall [see Use In Specific Populations]
Nervous system disorders: Seizures [see WARNINGS AND PRECAUTIONS], disorientation, movement disorder, loss of consciousness
Psychiatric disorders: Delirium, insomnia, panic attack
Read the entire FDA prescribing information for Marinol (Dronabinol Capsules)
© Marinol Patient Information is supplied by Cerner Multum, Inc. and Marinol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.