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
|