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adverse reactions
ADVERSE REACTIONS Commonly Observed The most commonly observed adverse events associated with the use of estazolam, not seen at an equivalent incidence among placebo-treated patients were somnolence, hypokinesia, dizziness, and abnormal coordination. Associated with Discontinuation of Treatment Approximately 3% of 1277 patients who received estazolam in U.S. premarketing clinical trials discontinued treatment because of an adverse clinical event. The only event commonly associated with discontinuation, accounting for 1.3% of the total, was somnolence. Incidence in Controlled Clinical Trials The table below enumerates adverse events that occurred at an incidence of 1% or greater among patients with insomnia who received estazolam in 7-night, placebo-controlled trials. Events reported by investigators were classified into standard dictionary (COSTART) terms to establish event frequencies. Event frequencies reported were not corrected for the occurrence of these events at baseline. The frequencies were obtained from data pooled across six studies: estazolam, N=685; placebo, N=433. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice in which patient characteristics and other factors differ from those that prevailed in these six clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials was conducted under a different set of conditions. However, the cited figures provide the physician with a basis of estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied. INCIDENCE OF ADVERSE EXPERIENCES IN PLACEBO-CONTROLLED CLINICAL TRIALS (Percentage of Patients Reporting) *Events reported by at least 1% of estazolam patients. Body System/ Estazolam Placebo Adverse Event* (N=685) (N=433) Body as Hyperlink Whole Headache 16 27 Asthenia 11 8 Malaise 5 5 Lower extremity pain 3 2 Back pain 2 2 Body pain 2 2 Abdominal pain 1 2 Chest Pain 1 1 Digestive System Nausea 4 5 Dyspepsia 2 2 Musculoskeletal System Stiffness 1 - Nervous System Somnolence 42 27 Hypokinesia 8 4 Nervousness 8 11 Dizziness 7 3 Coordination abnormal 4 1 Hangover 3 2 Confusion 2 - Depression 2 3 Dream abnormal 2 2 Thinking abnormal 2 1 Respiratory System Cold symptoms 3 5 Pharyngitis 1 2 Skin and Appendages Pruritus 1 - Other Adverse Events During clinical trials conducted by Abbott, some of which were not placebo-controlled, estazolam was administered to approximately 1300 patients. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing adverse events, similar types of untoward events must be grouped into a smaller number of standardized event categories. In the tabulations that follow, a standard COSTART dictionary terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the 1277 individuals exposed to estazolam who experienced an event of the type cited on at least one occasion while receiving estazolam. All reported events are included except those already listed in the previous table, those COSTART terms too general to be informative, and those events where a drug cause was remote. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in less than 1/1000 patients. It is important to emphasize that, although the events reported did occur during treatment with estazolam, they were not necessarily caused by it. Body as a Whole Infrequent Allergic reaction, chills, fever, neck pain, upper extremity pain Rare Edema, jaw pain, swollen breast Cardiovascular System Infrequent Flushing, palpitation Rare Arrhythmia, syncope Digestive System Frequent Constipation, dry mouth Infrequent Decreased appetite, flatulence, gastritis, increased appetite, vomiting Rare Enterocolitis, melena, ulceration of the mouth Endocrine System Rare Thyroid nodule Hematologic and Lymphatic System Rare Leukopenia, purpura, swollen lymph nodes Metabolic/Nutritional Disorders Infrequent Thirst Rare Increased SGOT, weight gain, weight loss Musculoskeletal System Infrequent Arthritis, muscle spasm, myalgia Rare Arthralgia Nervous System Frequent Anxiety Infrequent Agitation, amnesia, apathy, emotional lability, euphoria, hostility, paresthesia, seizure, sleep disorder, stupor, twitch Rare Ataxia, circumoral paresthesia, decreased libido, decreased reflexes, hallucinations, neuritis, nystagmus, tremor Minor Changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during estazolam therapy or withdrawal and are of no known clinical significance. Respiratory System Infrequent Asthma, cough, dyspnea, rhinitis, sinusitis Rare Epistaxis, hyperventilation, laryngitis Skin and Appendages Infrequent Rash, sweating, urticaria Rare Acne, dry skin Special Senses Infrequent Abnormal vision, ear pain, eye irritation, eye pain, eye swelling, perverse taste, photophobia, tinnitus Rare Decreased hearing, diplopia, scotomata Urogenital System Infrequent Frequent urination, menstrual cramps, urinary hesitancy, urinary urgency, vaginal discharge/itching Rare Hematuria, nocturia, oliguria, penile discharge, urinary incontinence Postintroduction Reports Voluntary reports of non-U.S. postmarketing experience with estazolam have included rare occurrences of photosensitivity, Stevens-Johnson syndrome, and agranulocytosis. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to estazolam treatment has not been determined.