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Estazolam (Estazolam) - Side Effects and 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)
 Body System/Adverse Event 1 Estazolam  (N = 685) Placebo (N = 433)
Body as a 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 -

1 Events reported by at least 1% of estazolam patients.

Other Adverse Events

During clinical trials, 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.



REPORTS OF SUSPECTED ESTAZOLAM SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Estazolam. The information is not vetted and should not be considered as verified clinical evidence.

Possible Estazolam side effects / adverse reactions in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-04

Patient: 30 year old female

Reactions: Dyspnoea, Intentional Overdose, Altered State of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Quazepam
    Administration route: Oral
    Indication: Depression

Clonazepam
    Administration route: Oral
    Indication: Depression

Tandospirone Citrate
    Administration route: Oral
    Indication: Depression

Etizolam
    Administration route: Oral
    Indication: Depression

Bromazepam
    Administration route: Oral
    Indication: Depression

Diazepam
    Administration route: Oral
    Indication: Depression

Chlordiazepoxide
    Administration route: Oral
    Indication: Depression

Medazepam
    Indication: Depression

Pentobarbital CAP
    Administration route: Oral
    Indication: Depression

Flunitrazepam
    Administration route: Oral
    Indication: Depression

Clomipramine Hydrochloride
    Administration route: Oral
    Indication: Depression

Clotiazepam
    Administration route: Oral

Phenobarbital TAB
    Administration route: Oral
    Indication: Depression

Oxazolam
    Administration route: Oral
    Indication: Depression

Cloxazolam
    Administration route: Oral
    Indication: Depression

Estazolam
    Administration route: Oral
    Indication: Depression

Mexazolam
    Administration route: Oral
    Indication: Depression

Alprazolam
    Administration route: Oral

Flutazolam
    Administration route: Oral
    Indication: Depression



Possible Estazolam side effects / adverse reactions in 61 year old male

Reported by a physician from Japan on 2011-11-09

Patient: 61 year old male

Reactions: Altered State of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Nexavar
    Dosage: daily dose: 800 mg
    Administration route: Oral
    Start date: 2011-10-01

Hypnotics and Sedatives

Nexavar
    Dosage: daily dose: 800 mg
    Administration route: Oral
    Indication: Hepatic Neoplasm Malignant
    Start date: 2011-10-07
    End date: 2011-10-01

Estazolam
    Administration route: Oral



Possible Estazolam side effects / adverse reactions in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-15

Patient: 30 year old female

Reactions: Dyspnoea, Intentional Overdose, Altered State of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Etizolam
    Administration route: Oral
    Indication: Depression

Cloxazolam
    Administration route: Oral
    Indication: Depression

Tandospirone Citrate
    Administration route: Oral
    Indication: Depression

Phenobarbital TAB
    Administration route: Oral
    Indication: Depression

Phenobarbital TAB
    Administration route: Oral
    Indication: Depression

Estazolam
    Administration route: Oral
    Indication: Depression

Flunitrazepam
    Administration route: Oral
    Indication: Depression

Quazepam
    Administration route: Oral
    Indication: Depression

Oxazolam
    Administration route: Oral
    Indication: Depression

Clonazepam
    Administration route: Oral
    Indication: Depression

Bromazepam
    Administration route: Oral
    Indication: Depression

Diazepam
    Administration route: Oral
    Indication: Depression

Flutazolam
    Administration route: Oral
    Indication: Depression

Clotiazepam
    Administration route: Oral
    Indication: Depression

Alprazolam
    Administration route: Oral
    Indication: Depression

Clomipramine HCL
    Administration route: Oral
    Indication: Depression

Chlordiazepoxide
    Administration route: Oral
    Indication: Depression

Medazepam
    Indication: Depression

Mexazolam
    Administration route: Oral
    Indication: Depression



See index of all Estazolam side effect reports >>

Drug label data at the top of this Page last updated: 2012-07-31

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