Medical Editor: John P. Cunha, DO, FACOEP
Cesamet (nabilone) is a man-made form of cannabis (marijuana is an herbal form of cannabis) used to treat severe nausea and vomiting that is caused by cancer chemotherapy. Cesamet is for use only when other medications have been unable to control the nausea and vomiting. Common side effects of Cesamet include dizziness, drowsiness, dry mouth, feeling "high", an exaggerated sense of well-being (euphoria), lightheadedness, headache, trouble sleeping (insomnia), memory problems, weakness, lack of coordination, depression, anxiety, confusion, or trouble concentrating.
The usual adult dosage of Cesamet is 1 or 2 mg twice daily. On the day of chemotherapy, the initial dose should be given 1 to 3 hours before the chemotherapy is administered. Cesamet may interact with amphetamines, medicine to treat attention deficit hyperactivity disorder (ADHD), prescription or over-the-counter weight loss aids, antidepressants, barbiturates, sedatives, 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 and supplements you use. Cesamet is not recommended for use during pregnancy because of possible fetus/infant harm reported with marijuana exposure (Cesamet is similar to a substance found in marijuana). It is unknown if this drug passes into breast milk. Because other cannabinoids pass into breast milk, breastfeeding while using this drug is not recommended.
Our Cesamet (nabilone) 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 nabilone and call your doctor at once if you have any of these serious side effects:
- hallucinations (seeing or hearing things that are not there);
- paranoia, extreme fear;
- fast heart rate;
- feeling light-headed, fainting; or
- unusual thoughts or behavior.
Continue using nabilone and talk with your doctor if you have any of these less serious side effects:
- dizziness, drowsiness;
- feeling "high";
- weakness, lack of coordination;
- depression, anxiety, confusion;
- dry mouth;
- headache, trouble concentrating; 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 Cesamet (Nabilone Capsules)
SIDE EFFECTS
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Commonly Encountered Reactions
During controlled clinical trials of Cesamet, virtually all patients experienced at least one adverse reaction. The most commonly encountered events were drowsiness, vertigo, dry mouth, euphoria (feeling “high”), ataxia, headache, and concentration difficulties.
Comparative Incidence of Reactions
Accurate estimates of the incidence of adverse events associated with the use of any drug are difficult to obtain. Estimates are influenced by factors such as drug dose, detection technique, setting, and physician judgments, among others. Consequently, the tables presented below are presented solely to indicate the relative frequency of adverse events reported in representative controlled clinical studies conducted to evaluate the safety and efficacy of Cesamet under relatively similar conditions of use. The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice, in which patient characteristics and other factors may differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products because each group of drug trials is conducted under a different set of conditions.
Finally, it is important to emphasize that these tabulations do not reflect the relative severity and/or clinical importance of the adverse events. A better perspective on the serious adverse events associated with the use of Cesamet is provided in the WARNINGS AND PRECAUTIONS sections.
The following tables list in order of decreasing frequency the adverse reactions encountered by a substantial proportion of patients treated with Cesamet participating in representative controlled clinical trials.
Incidence of Adverse Reactions in Placebo-Controlled
Studies
| Adverse Event | Nabilone (n=132) |
Placebo (n=119) |
||
| Patients | Percent | Patients | Percent | |
| Vertigo | 69 | 52 | 3 | 3 |
| Drowsiness | 69 | 52 | 6 | 5 |
| Dry Mouth | 47 | 36 | 2 | 2 |
| Ataxia | 19 | 14 | 0 | 0 |
| Euphoria | 14 | 11 | 1 | 1 |
| Sleep Disturbance | 14 | 11 | 1 | 1 |
| Dysphoria | 12 | 9 | 0 | 0 |
| Headache | 8 | 6 | 0 | 0 |
| Nausea | 5 | 4 | 0 | 0 |
| Disorientation | 3 | 2 | 0 | 0 |
| Depersonalization | 2 | 2 | 1 | 1 |
Incidence of Adverse Reactions in Active-Controlled
Studies
| Adverse Event | Nabilone (n=250) |
Prochlorperazine (n=232) |
||
| Patients | Percent | Patients | Percent | |
| Drowsiness | 165 | 66 | 108 | 47 |
| Vertigo/Dizziness | 147 | 59 | 53 | 23 |
| Euphoria | 95 | 38 | 12 | 5 |
| Dry Mouth | 54 | 22 | 11 | 5 |
| Depression | 35 | 14 | 37 | 16 |
| Ataxia | 32 | 13 | 4 | 2 |
| Visual Disturbance | 32 | 13 | 9 | 4 |
| Concentration Difficulties | 31 | 12 | 3 | 1 |
| Hypotension | 20 | 8 | 3 | 1 |
| Asthenia | 19 | 8 | 10 | 4 |
| Anorexia | 19 | 8 | 22 | 9 |
| Headache | 18 | 7 | 14 | 6 |
| Sedation | 7 | 3 | 2 | 1 |
| Increased Appetite | 6 | 2 | 2 | 1 |
Adverse Reactions by Body System-The following list of adverse events is organized by decreasing frequency within body systems for patients treated with Cesamet in controlled clinical trials. All events are listed regardless of causality assessment.
Blood and Hematopoietic-Anemia
Cardiovascular-Orthostatic hypotension, hypotension, tachycardia, syncope, palpitation, flushing, hypertension, arrhythmia, and cerebral vascular accident.
Eye and Ear-Vision disturbance, ear tightness, eye irritation, eye dryness, equilibrium dysfunction, tinnitus, eye disorder, amblyopia, eye swelling, eyelid diseases, pupil dilation, photophobia, and visual field defect.
Gastrointestinal-Dry mouth, nausea, anorexia, vomiting, diarrhea, abdominal pain, constipation, aphthous ulcer, mouth irritation, gastritis, and dyspepsia.
Genitourinary-Increased urination, decreased urination, hot flashes, urinary retention, and frequency of micturition.
Infection-Bacterial infection
Metabolic and Endocrine-Thirst
Musculoskeletal-Muscle pain, back pain, neck pain, joint pain, and unspecified pain.
Nervous System-Drowsiness, vertigo, ataxia, decreased concentration, sedation, hallucinations, paresthesia, tremor, memory disturbance, perception disturbance, convulsions, dystonia, numbness, and akathisia.
Psychiatric-Euphoria (feeling “high”), sleep disturbance, depression, confusion, disorientation, anxiety, depersonalization syndrome, speech disorder, abnormal dreams, insomnia, mood swings, inebriated feeling, toxic psychosis, paranoia, apathy, thought disorder, withdrawal, panic disorder, phobic neurosis, emotional disorder, and hyperactivity.
Respiratory-Dyspnea, pharyngitis, nasal congestion, sinus headache, thick tongue, dry throat, dry nose, wheezing, nosebleed, cough, voice change, and chest pain.
Skin and Appendages-Anhidrosis, photosensitivity, pruritus, rash, and allergic reactions.
Miscellaneous and Ill-Defined Conditions-Headache, fatigue, lightheadedness, coordination disturbance, asthesia, dysphoria, dizziness, taste change, excessive appetite, chills, excessive sweating, nervousness, malaise, postural dizziness, twitch, irritability, fever, inhibited walking, unconsciousness, hypotonia, and impaired urination.
Postmarketing Adverse Reactions-Cesamet has been marketed internationally since 1982. The following adverse reactions listed in order of decreasing frequency by body system have been reported since Cesamet has been marketed. All events are listed regardless of causality assessment.
Blood and Hematopoietic-Leukopenia
Cardiovascular-Hypotension and tachycardia
Eye and Ear-Visual disturbances
Gastrointestinal-Dry mouth, nausea, vomiting, and constipation
Nervous System-Hallucinations, CNS depression, CNS stimulation, ataxia, stupor, vertigo, convulsion, and circumoral paresthesia
Psychiatric-Somnolence, confusion, euphoria, depression, dysphoria, depersonalization, anxiety, psychosis, and emotional lability
Miscellaneous and Ill-Defined Conditions-Dizziness, headache, insomnia, abnormal thinking, chest pain, lack of effect, and face edema
Drug Abuse And Dependence
Controlled Substance
Cesamet, a synthetic cannabinoid pharmacologically related to Cannabis sativa L. (Marijuana; (delta-9-THC) is a highly abusable substance. Cesamet is controlled under Schedule II (CII) of the Controlled Substances Act. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet may produce subjective side effects which may be interpreted as a euphoria or marijuana-like “high” at therapeutic doses.
It is not known what proportion of individuals exposed chronically to Cesamet or other cannabinoids will develop either psychological or physical dependence. Long term use of these compounds has, however, been associated with disorders of motivation, judgment, and cognition. It is not clear, though, if this is a manifestation of the underlying personalities of chronic users of this class of drugs or if cannabinoids are directly responsible for these effects. An abstinence syndrome has been reported following discontinuation of delta-9-THC at high doses of 200 mg per day for 12 to 16 consecutive days. The acute phase was characterized by psychic distress, insomnia, and signs of autonomic hyperactivity (sweating, rhinorrhea, loose stools, hiccups). A protracted abstinence phase may have occurred in subjects who reported sleep disturbances for several weeks after delta-9-THC discontinuation.
Abuse
Cesamet may produce subjective side effects that may be interpreted as a euphoria or marijuana-like “high” at therapeutic doses. Cesamet was shown to be qualitatively and quantitatively similar to delta-9-THC in the production of cannabis-like effects, thus demonstrating that Cesamet has a high potential for abuse.
Preclinical studies performed in both dogs and monkeys demonstrated that Cesamet was cannabinoid-like. As with delta-9-THC, tolerance develops rapidly to the pharmacological effects in both the dog and the monkey. Cross-tolerance between Cesamet and delta-9-THC was demonstrated in the monkey.
Dependence
The physical dependence capacity of Cesamet is unknown at this time. Patients who participated in clinical trials of up to 5 days' duration evidenced no withdrawal symptoms on cessation of dosing.
Read the entire FDA prescribing information for Cesamet (Nabilone Capsules)
Read the Cesamet User Reviews »
© Cesamet Patient Information is supplied by Cerner Multum, Inc. and Cesamet Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
