ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 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
|
|
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
|
REPORTS OF SUSPECTED CESAMET SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Cesamet. The information is not vetted and should not be considered as verified clinical evidence.
Possible Cesamet side effects / adverse reactions in 55 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-04-12
Patient: 55 year old female
Reactions: Drug Interaction, Disorientation, Headache, Somnolence, Pulse Pressure Increased, Balance Disorder, Palpitations, Dizziness, Hallucination, Muscle Spasms, Vomiting, Dyspnoea, Urinary Tract Infection, Anxiety, Euphoric Mood, Diarrhoea, Hypopnoea, Disturbance in Attention, Gait Disturbance, Asthenia
Suspect drug(s):
Baclofen
Dosage: 60 mg
Butrans
Dosage: 240 mcg
Butrans
Dosage: 360 mcg
Butrans
Dosage: 120 mcg
Butrans
Dosage: 480 mcg
Cesamet
Administration route: Oral
Clonazepam
Dosage: 3 mg
Administration route: Oral
Escitalopram
Dosage: 20 mg
Administration route: Oral
Other drugs received by patient: Cipro XR
Possible Cesamet side effects / adverse reactions in 80 year old male
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: 80 year old male weighing 78.0 kg (171.6 pounds)
Reactions: Lung Disorder, Nausea, Pulmonary Oedema, Asthenia
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Cesamet
Possible Cesamet side effects / adverse reactions in 55 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-31
Patient: 55 year old female
Reactions: Drug Interaction, Headache, Disorientation, Somnolence, Pulse Pressure Increased, Balance Disorder, Palpitations, Dizziness, Hallucination, Muscle Spasms, Dyspnoea, Vomiting, Urinary Tract Infection, Anxiety, Euphoric Mood, Diarrhoea, Hypopnoea, Disturbance in Attention, Gait Disturbance, Asthenia
Suspect drug(s):
Baclofen
Dosage: 60 mg (20 mg,3 in 1 d)
Buprenorphine
Dosage: 240 mcg(10mcg,1 in 1 hr),360 mcg(15mcg,1 in 1 hr),480 mcg (20mcg,1 in 1 hr),120 mcg (5 mcg,1 in 1 hr
Cesamet
Dosage: (0.25 mg), oral
Administration route: Oral
Clonazepam
Dosage: 3 mg (1 mg,3 in 1 d), oral
Administration route: Oral
Escitalopram Oxalate
Dosage: 20 mg (20 mg, 1 in 1 d),oral
Administration route: Oral
|