DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Triazolam (Triazolam) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

During placebo-controlled clinical studies in which 1,003 patients received triazolam tablets, the most troublesome side effects were extensions of the pharmacologic activity of triazolam, e.g., drowsiness, dizziness, or light-headedness.

The figures cited below are estimates of untoward clinical event incidence among subjects who participated in the relatively short duration (i.e., 1 to 42 days) placebo-controlled clinical trials of triazolam. The figures cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors often differ from those in clinical trials. These figures cannot be compared with those obtained from other clinical studies involving related drug products and placebo, as each group of drug trials is conducted under a different set of conditions.

Comparison of the cited figures, however, can provide the prescriber with some basis of estimating the relative contributions of drug and nondrug factors to the untoward event incidence rate in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient while inducing it in others. (For example, an anticholinergic, anxiolytic drug may relieve dry mouth [a sign of anxiety] in some subjects but induce it [an untoward event] in others.)

Triazolam Placebo
Number of Patients 1003 997
% Patients Reporting:
Central Nervous System
Drowsiness 14 6.4
Headache 9.7 8.4
Dizziness 7.8 3.1
Nervousness 5.2 4.5
Light-headedness 4.9 0.9
Coordination disorders/ataxia 4.6 0.8
Gastrointestinal
Nausea/vomiting 4.6 3.7

In addition to the relatively common (i.e., 1% or greater) untoward events enumerated above, the following adverse events have been reported less frequently (i.e., 0.9% to 0.5%): euphoria, tachycardia, tiredness, confusional states/memory impairment, cramps/pain, depression, visual disturbances.

Rare (i.e., less than 0.5%) adverse reactions included constipation, taste alterations, diarrhea, dry mouth, dermatitis/allergy, dreaming/nightmares, insomnia, paresthesia, tinnitus, dysesthesia, weakness, congestion, death from hepatic failure in a patient also receiving diuretic drugs.

In addition to these untoward events for which estimates of incidence are available, the following adverse events have been reported in association with the use of triazolam and other benzodiazepines: amnestic symptoms (anterograde amnesia with appropriate or inappropriate behavior), confusional states (disorientation, derealization, depersonalization, and/or clouding of consciousness), dystonia, anorexia, fatigue, sedation, slurred speech, jaundice, pruritus, dysarthria, changes in libido, menstrual irregularities, incontinence, and urinary retention. Other factors may contribute to some of these reactions, e.g., concomitant intake of alcohol or other drugs, sleep deprivation, an abnormal premorbid state, etc.

Other events reported include: paradoxical reactions such as stimulation, mania, an agitational state (restlessness, irritability, and excitation), increased muscle spasticity, sleep disturbances, hallucinations, delusions, aggressiveness, falling, somnambulism, syncope, inappropriate behavior and other adverse behavioral effects. Should these occur, use of the drug should be discontinued.

The following events have also been reported: chest pain, burning tongue/glossitis/stomatitis.

Laboratory analyses were performed on all patients participating in the clinical program for triazolam. The following incidences of abnormalities were observed in patients receiving triazolam and the corresponding placebo group. None of these changes were considered to be of physiological significance.

Triazolam Placebo
Number of patients 380 361
% of Patients Reporting Low High Low High
Hematology
Hematocrit * * * *
Hemoglobin * * * *
Total WBC count 1.7 2.1 * 1.3
Neutrophil count 1.5 1.5 3.3 1
Lymphocyte count 2.3 4 3.1 3.8
Monocyte count 3.6 * 4.4 1.5
Eosinophil count 10.2 3.2 9.8 3.4
Basophil count 1.7 2.1 * 1.8
Urinalysis
Albumin - 1.1 - *
Sugar - * - *
RBC/HPF - 2.9 - 2.9
WBC/HPF - 11.7 - 7.9
Blood chemistry
Creatinine 2.4 1.9 3.6 1.5
Bilirubin * 1.5 1 *
SGOT * 5.3 * 4.5
Alkaline phosphatase * 2.2 * 2.6

*Less than 1%

When treatment with triazolam is protracted, periodic blood counts, urinalysis, and blood chemistry analyses are advisable.

Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during therapy with triazolam and are of no known significance.



REPORTS OF SUSPECTED TRIAZOLAM SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Triazolam side effects / adverse reactions in 86 year old female

Reported by a pharmacist from Japan on 2011-10-07

Patient: 86 year old female

Reactions: Renal Impairment, Depressed Level of Consciousness

Suspect drug(s):
Triazolam
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-26

Risperdal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-26



Possible Triazolam side effects / adverse reactions in 26 year old female

Reported by a physician from Japan on 2011-10-27

Patient: 26 year old female weighing 55.0 kg (121.0 pounds)

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Suspect drug(s):
Clonidine Hydrochloride
    Administration route: Oral
    Indication: Pain
    Start date: 2011-06-06
    End date: 2011-06-17

Prochlorperazine Maleate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-07
    End date: 2011-06-16

Codein Phosphate
    Dosage: 1 as necessary
    Administration route: Oral
    Start date: 2011-06-06

Sennoside
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-11
    End date: 2011-05-30

Betahistine Mesilate
    Dosage: 1 as necessary
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-23
    End date: 2011-06-05

Fentanyl-100
    Indication: Pain
    Start date: 2011-05-30
    End date: 2011-06-06

Fentanyl-100
    Start date: 2011-06-28
    End date: 2011-06-30

Fentanyl-100
    Start date: 2011-07-01
    End date: 2011-08-01

Tramadol HCL
    Dosage: 1 as needed
    Administration route: Oral
    Indication: Pain
    Start date: 2011-06-27

Magnesium Oxide
    Dosage: 1 as needed
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-11
    End date: 2011-05-30

Morphine HCL Elixir
    Dosage: 1 as necessary
    Administration route: Oral
    Start date: 2011-06-24

Metoclopramide
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-30
    End date: 2011-06-06

Difenidol Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-07
    End date: 2011-07-03

Codein Phosphate
    Dosage: 1 as necessary
    Administration route: Oral
    Indication: Pain
    Start date: 2011-06-13

Eperisone Hydrochloride
    Administration route: Oral
    Indication: Pain
    Start date: 2011-07-04
    End date: 2011-07-14

Alprazolam
    Dosage: 1 as necessary
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-30
    End date: 2011-08-05

Pregabalin
    Administration route: Oral
    Indication: Pain
    Start date: 2011-07-04
    End date: 2011-08-05

Morphine HCL Elixir
    Dosage: 1 as necessary
    Administration route: Oral
    Indication: Pain
    Start date: 2011-06-20

Clonidine Hydrochloride
    Administration route: Oral
    Start date: 2011-05-23
    End date: 2011-06-05

Fentanyl-100
    Start date: 2011-06-06
    End date: 2011-06-27

Codein Phosphate
    Dosage: 1 as necessary
    Administration route: Oral
    Start date: 2011-05-30

Loxoprofen Sodium
    Dosage: 1 as necessary
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-23
    End date: 2011-06-05

Triazolam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-30
    End date: 2011-08-05

Zolpidem Tartrate
    Dosage: 1 as necessary
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-27
    End date: 2011-08-05

Sertraline Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-04
    End date: 2011-08-05



Possible Triazolam side effects / adverse reactions in 72 year old male

Reported by a individual with unspecified qualification from Japan on 2011-10-28

Patient: 72 year old male

Reactions: Rhabdomyolysis, Interstitial Lung Disease, Decreased Appetite, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):
Doral
    End date: 2011-08-04

Feburic (Febuxostat)
    Dosage: 10 mg (10 mg,1 in 1 d) per oral ; 10 mg (10 mg,1 in 1 d) per oral
    Administration route: Oral
    Indication: Gout
    Start date: 2011-07-01
    End date: 2011-07-04

Feburic (Febuxostat)
    Dosage: 10 mg (10 mg,1 in 1 d) per oral ; 10 mg (10 mg,1 in 1 d) per oral
    Administration route: Oral
    Indication: Gout
    Start date: 2011-08-02
    End date: 2011-08-04

Triazolam
    Dosage: per oral
    Administration route: Oral
    End date: 2011-08-04

Zolpidem Tartrate

Allopurinol
    Dosage: 100 mg (100 mg) oral
    Administration route: Oral
    Start date: 2011-07-01
    End date: 2011-08-04

Other drugs received by patient: Betamethasone; Metolate (Methotrexate); Arcrane (Sodium Alginate); Etisedan (Etizolam); Folic Acid



See index of all Triazolam side effect reports >>

Drug label data at the top of this Page last updated: 2010-10-18

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017