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Diastat Pediatric Side Effects

Generic name: diazepam

Medically reviewed by Drugs.com. Last updated on Mar 10, 2024.

Note: This document provides detailed information about Diastat Pediatric.

For healthcare professionals

Applies to diazepam: buccal film, compounding powder, injectable solution, intravenous suspension, nasal spray, oral capsule extended release, oral concentrate, oral solution, oral tablet, rectal kit.

General

ORAL: The most commonly reported side effects included ataxia, drowsiness, fatigue, and muscle weakness.

PARENTERAL: The most commonly reported side effects included fatigue, drowsiness, ataxia, injection-site venous thrombosis, and injection-site phlebitis Side Effects associated with diazepam. Some dosage forms listed on this page may not apply specifically to the brand name Diastat Pediatric.

For healthcare professionals

Applies to diazepam: buccal film, compounding powder, injectable solution, intravenous suspension, nasal spray, oral capsule extended release, oral concentrate, oral solution, oral tablet, rectal kit.

General

ORAL: The most commonly reported side effects included ataxia, drowsiness, fatigue, and muscle weakness.

PARENTERAL: The most commonly reported side effects included fatigue, drowsiness, ataxia, injection-site venous thrombosis, and injection-site phlebitis.

RECTAL: The most commonly reported side effects included somnolence, headache, and diarrhea.[Ref]

Nervous system

ORAL:

PARENTERAL:

RECTAL:

Drowsiness, headache, dizziness, ataxia, and reduced alertness occurred at the start of treatment, but usually disappeared with continued use.

Anterograde amnesia is a dose-related side effect that may occur at therapeutic doses.

Tremor, disrupted sensory perception, and epileptic attacks occurred in patients with withdrawal symptoms.

Drowsiness, sedation, unsteadiness, and ataxia are dose-related and may persist into the following day, even with single doses.

Prolonged use of treatment in elderly patients may result in dementia.[Ref]

Psychiatric

ORAL:

PARENTERAL:

RECTAL:

Confusion and numbed emotions occurred at the start of treatment, but usually disappeared with continued use. Confusion has occurred in elderly patients who received high doses.

Inappropriate behavior may occur with anterograde amnesia.

Psychic and physical dependence occurred with chronic use at therapeutic doses; withdrawal symptoms may occur in patients with dependence when treatment is discontinued.

Anxiety, panic, irritability, aggressiveness/aggression, paranoid psychosis, and delirium occurred in patients with withdrawal symptoms.

Restlessness, agitation, irritability, aggressiveness/aggression, rage, delusions, nightmares, psychoses, hallucinations, and inappropriate behavior occurred in patients with paradoxical reactions, especially in elderly and pediatric patients.

Increased REM sleep and broken sleep with vivid dreams may persist for weeks after treatment is discontinued.[Ref]

Respiratory

ORAL:

PARENTERAL:

RECTAL:

Increased bronchial secretions were reported, especially in pediatric patients.

Respiratory depression and apnea occurred, especially with high doses.

Coughing, respiratory depression, dyspnea, hyperventilation, laryngospasm, and throat/chest pain have been reported in patients undergoing peroral endoscopic procedures.[Ref]

Other

ORAL:

PARENTERAL:

RECTAL:

Fatigue occurred at the start of treatment, but usually disappeared with continued use.

Elderly patients have an increased risk of falling.

Patients with physical/psychic dependence may experience rebound effects during discontinuation.

General malaise occurred in patients with withdrawal symptoms.

Pain occurred with injection formulations.[Ref]

Cardiovascular

ORAL:

PARENTERAL:

RECTAL:

Palpitations occurred in patients with withdrawal symptoms.

Thrombophlebitis and venous thrombosis have occurred with injection formulations.

Ischemia occurred with inadvertent intra-arterial administration.[Ref]

Local

PARENTERAL:

Musculoskeletal

ORAL:

PARENTERAL:

RECTAL:

Muscle weakness occurred at the start of treatment, but usually disappeared with continued use.

Elderly patients and/or those taking sedatives/alcohol concomitantly have an increased risk of fractures associated with falls.

Muscle spasms occurred in patients with withdrawal symptoms.

Tissue necrosis occurred with inadvertent intra-arterial administration.[Ref]

Gastrointestinal

ORAL:

PARENTERAL:

RECTAL:

Increased salivation has been reported, especially in pediatric patients.

Gastrointestinal disorders occurred in patients with withdrawal symptoms.[Ref]

Metabolic

ORAL:

PARENTERAL:

RECTAL:

Appetite loss occurred in patients with withdrawal symptoms.[Ref]

Dermatologic

ORAL:

PARENTERAL:

RECTAL:

Sweating occurred in patients with withdrawal symptoms.[Ref]

Ocular

ORAL:

PARENTERAL:

RECTAL:

Double vision occurred at the start of treatment, but usually disappeared with continued use.[Ref]

Hematologic

ORAL:

PARENTERAL:

RECTAL:

Genitourinary

ORAL:

PARENTERAL:

RECTAL:

Hepatic

ORAL:

PARENTERAL:

RECTAL:

Hypersensitivity

ORAL:

PARENTERAL:

RECTAL:

Renal

PARENTERAL:

Endocrine

ORAL:

PARENTERAL:

RECTAL:

References

1. (2002) "Product Information. Valium (diazepam)." Roche Laboratories

2. (2001) "Product Information. Dizac (diazepam)." OHMEDA

3. (2001) "Product Information. Diastat (diazepam)." Athena Neurosciences Inc

4. Cerner Multum, Inc. "UK Summary of Product Characteristics."

5. Cerner Multum, Inc. "Australian Product Information."

Further information

Diastat Pediatric side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.