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adverse reactions
ADVERSE REACTIONS 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 Nabilone (n=132) Placebo (n=119) Adverse Event 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 Nabilone (n=250) Prochlorperazine (n=232) Adverse Event 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 To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.