HALCION®, CIV Adverse Reactions

(triazolam)

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections:

Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1)]
Abuse, Misuse, and Addiction [see Warnings and Precautions (5.2)]
Dependence and Withdrawal Reactions [see Warnings and Precautions (5.3)]
Persistent or Worsening Insomnia [see Warnings and Precautions (5.4)]
"Sleep-driving" and Other Complex Behaviors [see Warnings and Precautions (5.5)]
Central Nervous System Manifestations [see Warnings and Precautions (5.6)]
Effects on Driving and Operating Heavy Machinery [see Warnings and Precautions (5.7)]
Patients with Depression [see Warnings and Precautions (5.9)]
Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.10)]
Compromised Respiratory Function [see Warnings and Precautions (5.11)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidences cited below are estimates of clinical reactions among 1003 subjects who participated in the short term (duration of 1 to 42 days) placebo-controlled clinical trials of Halcion.

Adverse reactions leading to discontinuation in two multi-dose placebo controlled clinical trials include coordination disorders, drowsiness, grogginess, somnolence, depression, restlessness, dizziness, lightheadedness, headache, nausea, visual disturbance, nervousness, abdominal distress, bladder trouble, aching limbs, backache, and blepharitis.

Table 1: Common Adverse Drug Reactions in 1% or More of Halcion-Treated Subjects (and Greater than Placebo) Reported in Placebo-Controlled Clinical Trials
EventHalcion
(N=1003)
% Patients Reporting
Placebo
(N=997)
% Patients Reporting

Central Nervous System

  Drowsiness

14.0

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 common reactions enumerated above in Table1, the following adverse reactions have been reported at an incidence of 0.9% to 0.5%: euphoria, tachycardia, tiredness, confusional states/memory impairment, cramps/pain, depression, and visual disturbances.

Adverse reactions reported at an incidence less than 0.5% include: constipation, taste alterations, diarrhea, dry mouth, dermatitis/allergy, dreaming/nightmares, insomnia, paresthesia, tinnitus, dysesthesia, weakness, congestion, and death from hepatic failure in a patient also receiving diuretic drugs.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Halcion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General disorders and administration site conditions: Paradoxical drug reaction, chest pain and fatigue
Gastrointestinal disorders: Tongue discomfort, glossitis, stomatitis
Hepatobiliary disorders: Jaundice
Injury, poisoning and procedural complications: Fall
Metabolism and nutrition disorders: Anorexia
Nervous system disorders: Anterograde amnesia, altered state of consciousness, dystonia, sedation, syncope, dysarthria and muscle spasticity
Psychiatric disorders: Confusional state (disorientation, derealisation, depersonalization), mania, agitation, restlessness, irritability, sleep disorder and libido disorder, hallucination, delusion, aggression, somnambulism, and abnormal behavior
Renal and urinary disorders: Urinary retention and urinary incontinence
Reproductive system and breast disorders: Menstruation irregular
Skin and subcutaneous tissue disorders: Pruritis

Find HALCION®, CIV medical information:

Find HALCION®, CIV medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

HALCION®, CIV Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Adverse Reactions

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections:

Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1)]
Abuse, Misuse, and Addiction [see Warnings and Precautions (5.2)]
Dependence and Withdrawal Reactions [see Warnings and Precautions (5.3)]
Persistent or Worsening Insomnia [see Warnings and Precautions (5.4)]
"Sleep-driving" and Other Complex Behaviors [see Warnings and Precautions (5.5)]
Central Nervous System Manifestations [see Warnings and Precautions (5.6)]
Effects on Driving and Operating Heavy Machinery [see Warnings and Precautions (5.7)]
Patients with Depression [see Warnings and Precautions (5.9)]
Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.10)]
Compromised Respiratory Function [see Warnings and Precautions (5.11)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidences cited below are estimates of clinical reactions among 1003 subjects who participated in the short term (duration of 1 to 42 days) placebo-controlled clinical trials of Halcion.

Adverse reactions leading to discontinuation in two multi-dose placebo controlled clinical trials include coordination disorders, drowsiness, grogginess, somnolence, depression, restlessness, dizziness, lightheadedness, headache, nausea, visual disturbance, nervousness, abdominal distress, bladder trouble, aching limbs, backache, and blepharitis.

Table 1: Common Adverse Drug Reactions in 1% or More of Halcion-Treated Subjects (and Greater than Placebo) Reported in Placebo-Controlled Clinical Trials
EventHalcion
(N=1003)
% Patients Reporting
Placebo
(N=997)
% Patients Reporting

Central Nervous System

  Drowsiness

14.0

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 common reactions enumerated above in Table1, the following adverse reactions have been reported at an incidence of 0.9% to 0.5%: euphoria, tachycardia, tiredness, confusional states/memory impairment, cramps/pain, depression, and visual disturbances.

Adverse reactions reported at an incidence less than 0.5% include: constipation, taste alterations, diarrhea, dry mouth, dermatitis/allergy, dreaming/nightmares, insomnia, paresthesia, tinnitus, dysesthesia, weakness, congestion, and death from hepatic failure in a patient also receiving diuretic drugs.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Halcion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General disorders and administration site conditions: Paradoxical drug reaction, chest pain and fatigue
Gastrointestinal disorders: Tongue discomfort, glossitis, stomatitis
Hepatobiliary disorders: Jaundice
Injury, poisoning and procedural complications: Fall
Metabolism and nutrition disorders: Anorexia
Nervous system disorders: Anterograde amnesia, altered state of consciousness, dystonia, sedation, syncope, dysarthria and muscle spasticity
Psychiatric disorders: Confusional state (disorientation, derealisation, depersonalization), mania, agitation, restlessness, irritability, sleep disorder and libido disorder, hallucination, delusion, aggression, somnambulism, and abnormal behavior
Renal and urinary disorders: Urinary retention and urinary incontinence
Reproductive system and breast disorders: Menstruation irregular
Skin and subcutaneous tissue disorders: Pruritis

Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information. 8AM-9PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.