Medical Editor: John P. Cunha, DO, FACOEP
What Is Marinol?
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.
What Are Side Effects of Marinol?
Marinol may cause serious side effects including:
- seizure,
- fast or pounding heartbeats,
- lightheadedness,
- confusion,
- trouble sleeping,
- problems with memory,
- difficulty concentrating,
- unusual changes in mood or behavior,
- restlessness,
- nervousness,
- irritableness,
- slurred speech,
- drowsiness,
- severe or ongoing nausea,
- vomiting,
- stomach pain,
- severe headache,
- blurred vision,
- pounding in your neck and ears,
- anxiety, and
- nosebleed
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Marinol include:
- mood changes,
- dizziness,
- drowsiness,
- confusion,
- trouble concentrating,
- feeling "high,"
- warmth or tingly feeling,
- an exaggerated sense of well-being,
- anxiety,
- lightheadedness,
- headache,
- red eyes,
- dry mouth,
- nausea,
- vomiting,
- stomach or abdominal pain,
- diarrhea,
- sleep problems (insomnia),
- clumsiness,
- lack of coordination,
- weakness, or
- unsteadiness.
Tell your doctor if you have serious side effects of Marinol including:
- fainting,
- fast heart rate or pounding heartbeat,
- seizure (convulsions),
- fainting,
- unusual thoughts or behavior, or
- mental/mood changes (such as nervousness, hallucinations, abnormal thoughts, extreme fear, or paranoia).
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Marinol?
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.
What Drugs, Substances, or Supplements Interact with Marinol?
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 During Pregnancy and Breastfeeding
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.
Additional Information
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.
SLIDESHOW
Skin Cancer Symptoms, Types, Images See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives, skin rash or burning; mouth sores; warmth, redness, or tingly feeling; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- a seizure;
- fast or pounding heartbeats;
- a light-headed feeling, like you might pass out;
- confusion, trouble sleeping, problems with memory or concentration;
- unusual changes in mood or behavior;
- restlessness, feeling nervous or irritable;
- slurred speech, drowsiness;
- severe or ongoing nausea, vomiting, or stomach pain; or
- increased blood pressure--severe headache, blurred vision, pounding in your neck or ears.
Common side effects may include:
- feeling "high";
- dizziness, drowsiness, thinking problems;
- unusual thoughts or fears;
- feelings of extreme happiness; or
- nausea, vomiting, stomach pain.
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.
SIDE EFFECTS
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 |
| General | Asthenia |
| 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 |
| Musculoskeletal | Myalgias |
| Central Nervous System | Depression, nightmares, speech difficulties, tinnitus |
| Respiratory | Cough, rhinitis, sinusitis |
| Skin | Flushing, sweating |
| Sensory | Vision difficulties |
Postmarketing Experience
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
Vascular disorders: Syncope [see WARNINGS AND PRECAUTIONS]
DRUG INTERACTIONS
Additive CNS Effects
Additive CNS effects (e.g., dizziness, confusion, sedation, somnolence) may occur when MARINOL is taken concomitantly with drugs that have similar effects on the central nervous system such as CNS depressants [see WARNINGS AND PRECAUTIONS].
Additive Cardiac Effects
Additive cardiac effects (e.g., hypotension, hypertension, syncope, tachycardia) may occur when MARINOL is taken concomitantly with drugs that have similar effects on the cardiovascular system [see WARNINGS AND PRECAUTIONS].
Effect Of Other Drugs On Dronabinol
Dronabinol is primarily metabolized by CYP2C9 and CYP3A4 enzymes based on published in vitro studies. Inhibitors of these enzymes may increase, while inducers may decrease, the systemic exposure of dronabinol and/or its active metabolite resulting in an increase in dronabinolrelated adverse reactions or loss of efficacy of MARINOL.
Monitor for potentially increased dronabinol-related adverse reactions when MARINOL is co-administered with inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) and inhibitors of CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice).
Highly Protein-Bound Drugs
Dronabinol is highly bound to plasma proteins, and therefore, might displace and increase the free fraction of other concomitantly administered protein-bound drugs.
Although this displacement has not been confirmed in vivo, monitor patients for increased adverse reactions to narrow therapeutic index drugs that are highly protein-bound (e.g., warfarin, cyclosporine, amphotericin B) when initiating treatment or increasing the dosage of MARINOL.
Drug Abuse And Dependence
Controlled Substance
MARINOL contains dronabinol capsules, a Schedule III controlled substance.
Abuse
MARINOL contains dronabinol, the main psychoactive component in marijuana. Ingestion of high doses of dronabinol increases the risk of psychiatric adverse reactions if abused or misused, while continued administration can lead to addiction. Psychiatric adverse reactions may include psychosis, hallucinations, depersonalization, mood alteration, and paranoia.
In an open-label study in patients with AIDS who received MARINOL for up to five months, no abuse, diversion or systematic change in personality or social functioning were observed despite the inclusion of a substantial number of patients with a past history of drug abuse.
Patients should be instructed to keep MARINOL in a secure place out of reach of others for whom the medication has not been prescribed.
Dependence
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use. Physical dependence manifests by drug class-specific withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. The appearance of a withdrawal syndrome when administration of the drug is terminated is the only actual evidence of physical dependence. Physical dependence can develop during chronic therapy with MARINOL, and develops after chronic abuse of marijuana.
A withdrawal syndrome was reported after the abrupt discontinuation of dronabinol in subjects receiving dosages of 210 mg per day for 12 to 16 consecutive days. Within 12 hours after discontinuation, subjects manifested symptoms such as irritability, insomnia, and restlessness. By approximately 24 hours post-dronabinol discontinuation, withdrawal symptoms intensified to include “hot flashes,” sweating, rhinorrhea, loose stools, hiccoughs, and anorexia. These withdrawal symptoms gradually dissipated over the next 48 hours.
Electroencephalographic changes consistent with the effects of drug withdrawal (hyperexcitation) were recorded in patients after abrupt dechallenge. Patients also complained of disturbed sleep for several weeks after discontinuing therapy with high dosages of dronabinol.
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.
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