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Commonly Encountered Reactions: During controlled clinical trials of Cesamet (nabilone capsules) , 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 (nabilone capsules) 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 (nabilone capsules) 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 (nabilone capsules) 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 (nabilone capsules) has been marketed internationally since 1982. The following adverse reactions listed in order of decreasing frequency by body system have been reported since Cesamet (nabilone capsules) 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 (nabilone capsules) , a synthetic cannabinoid pharmacologically related to Cannabis sativa L. (Marijuana; (delta-9-THC) is a highly abusable substance. Cesamet (nabilone capsules) is controlled under Schedule II (CII) of the Controlled Substances Act. Prescriptions for Cesamet (nabilone capsules) should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). Cesamet (nabilone capsules) 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 (nabilone capsules) 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 (nabilone capsules) may produce subjective side effects that may be interpreted as a euphoria or marijuana-like "high" at therapeutic doses. Cesamet (nabilone capsules) was shown to be qualitatively and quantitatively similar to approved oral delta-9-THC in the production of cannabis-like effects, thus demonstrating its potential for abuse.

Preclinical studies performed in both dogs and monkeys demonstrated that Cesamet (nabilone capsules) 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 (nabilone capsules) and delta-9-THC was demonstrated in the monkey.

Dependence - The physical dependence capacity of Cesamet (nabilone capsules) 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.