"The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Marinol Side Effects Center
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, 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 pain, diarrhea, sleep problems (insomnia), clumsiness, lack of coordination, weakness, or unsteadiness.
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. Breast-feeding 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Marinol in Detail - Patient Information: Side Effects
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)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Marinol Overview - Patient Information: Side Effects
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: fainting, fast/pounding heartbeat, mental/mood changes (such as anxiety, nervousness, hallucinations, abnormal thoughts, paranoia).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Marinol (Dronabinol)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Marinol FDA Prescribing Information: Side Effects
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 (dronabinol) 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 (dronabinol) Capsules in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%). (See Clinical Trials.)
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 (dronabinol) 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).
Body as a whole: Asthenia.
Digestive: Abdominal pain*, nausea*, vomiting*.
*Incidence of events 3% to 10%
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).
Cardiovascular: Conjunctivitis*, hypotension*.
Digestive: Diarrhea*, fecal incontinence.
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 MARINOL (dronabinol) Capsules treatment is unknown, but they are reported as alerting information for the clinician.
Body as a whole: Chills, headache, malaise.
Skin and Appendages: Sweating.
Seizure and seizure-like activity have been reported in patients receiving MARINOL (dronabinol) Capsules during marketed use of the drug and in clinical trials. (See PRECAUTIONS and OVERDOSAGE.) Reports of fatigue have also been received. A causal relationship between MARINOL (dronabinol) Capsules and these events has not been established.
Drug Abuse And Dependence
MARINOL (dronabinol) Capsules is one of the psychoactive compounds present in cannabis, and is abusable and controlled [Schedule III (CIII)] under the Controlled Substances Act. Both psychological and physiological dependence have been noted in healthy individuals receiving dronabinol, but addiction is uncommon and has only been seen after prolonged high dose administration.
Chronic abuse of cannabis has been associated with decrements in motivation, cognition, judgement, and perception. The etiology of these impairments is unknown, but may be associated with the complex process of addiction rather than an isolated effect of the drug. No such decrements in psychological, social or neurological status have been associated with the administration of MARINOL (dronabinol) Capsules for therapeutic purposes.
In an open-label study in patients with AIDS who received MARINOL (dronabinol) Capsules 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.
An abstinence syndrome has been reported after the abrupt discontinuation of dronabinol in volunteers receiving dosages of 210 mg/day for 12 to 16 consecutive days. Within 12 hours after discontinuation, these volunteers 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)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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