Cesamet Side Effects

Generic Name: nabilone

Please note - some side effects for Cesamet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Cesamet - for the Consumer

Cesamet

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cesamet:

Change in appetite; confusion; decreased coordination; dizziness; drowsiness; dry mouth; elevated or relaxed mood; headache; nausea; trouble concentrating; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior or thinking changes; distorted sense of time; fast heartbeat; hallucinations; memory changes; mental or mood changes (eg, anxiety, depression, detachment, exaggerated feeling of well-being, feeling disoriented, panic, paranoia); severe or persistent dizziness; vision changes.

Cesamet Side Effects - for the Professional

Cesamet

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 theWARNINGS andPRECAUTIONS 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.

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

Side Effects by Body System

Cardiovascular

Cardiovascular side effects have included orthostatic hypotension, hypotension, tachycardia, syncope, palpitation, flushing, hypertension, arrhythmia, and cerebral vascular accident.

Dermatologic

Dermatologic side effects have included anhidrosis, photosensitivity, pruritus, and rash.

Endocrine

Endocrine side effects have included thirst.

Gastrointestinal

Gastrointestinal side effects have included dry mouth, nausea, anorexia, vomiting, diarrhea, abdominal pain, constipation, aphthous ulcer, mouth irritation, gastritis, and dyspepsia.

Genitourinary

Genitourinary side effects have included increased urination, decreased urination, hot flashes, urinary retention, and frequency of micturition.

Hematologic

Hematologic side effects have included anemia and leukopenia.

Immunologic

Immunologic side effects have included bacterial infection.

Musculoskeletal

Musculoskeletal side effects have included muscle pain, back pain, neck pain, joint pain, and unspecified pain.

Ocular

Ocular side effects have included vision disturbance, eye irritation, eye dryness, eye disorder, amblyopia, eye swelling, eyelid diseases, pupil dilation, photophobia, and visual field defect.

Other

Other side effects have included ear tightness, tinnitus, equilibrium dysfunction, fatigue, lightheadedness, coordination disturbance, asthesia, dysphoria, dizziness, twitch, irritability, fever, inhibited walking, unconsciousness, hypotonia, and face edema.

Nervous system

Nervous system side effects have included drowsiness, vertigo, ataxia, decreased concentration, sedation, hallucinations, paresthesia, tremor, memory disturbance, perception disturbance, convulsions, dystonia, numbness, and akathisia.

Respiratory

Respiratory side effects have included dyspnea, pharyngitis, nasal congestion, sinus headache, thick tongue, dry throat, dry nose, wheezing, nosebleed, cough, and voice change.

Psychiatric

Psychiatric side effects have included 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.

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