Diastat Side Effects

Generic name: diazepam

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 10, 2024.

Note: This document provides detailed information about Diastat Side Effects associated with diazepam. Some dosage forms listed on this page may not apply specifically to the brand name Diastat.

Applies to diazepam: rectal gel/jelly.

Other dosage forms:

• oral solution, oral tablet
• injection solution
• nasal spray

Serious side effects of Diastat

Along with its needed effects, diazepam (the active ingredient contained in Diastat) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking diazepam:

Get emergency help immediately if any of the following symptoms of overdose occur while taking diazepam:

Symptoms of overdose

• agitation
• change or loss of consciousness
• changes in patterns and rhythms of speech
• confusion
• excitement
• irritability
• loss of strength or energy
• muscle pain or weakness
• restlessness
• shakiness and unsteady walk
• sleepiness or unusual drowsiness
• slurred speech
• talkativeness
• trouble in speaking
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual weak feeling

Other side effects of Diastat

Some side effects of diazepam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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:

• Common (1% to 10%): Ataxia, disrupted sensory perception, drowsiness, epileptic attacks, impaired motor ability, tremor
• Uncommon (0.1% to 1%): Amnesia/anterograde amnesia, balance disorders, concentration difficulties, dizziness, dysarthria, headache, slurred speech, vertigo
• Rare (0.01% to 0.1%): Decreased alertness, memory loss, syncope, unconsciousness
• Frequency not reported: Abnormal taste, amnestic effects, hangover effect, hypersensitivity to physical/visual/auditory stimuli, oversedation, perceptual disturbances

PARENTERAL:

• Common (1% to 10%): Ataxia, disrupted sensory perception, dizziness, drowsiness, epileptic attacks, impaired motor ability, tremor
• Uncommon (0.1% to 1%): Amnesia/anterograde amnesia, balance disorders, concentration difficulties, headache, increased seizure incidence/severity, lightheadedness, minor electroencephalogram (EEG) changes, slurred speech, vertigo
• Rare (0.01% to 0.1%): Convulsions, decreased alertness, dysarthria, extrapyramidal effects, memory loss, syncope, unconsciousness
• Frequency not reported: Abnormal taste, amnestic effects, hangover effect, hypersensitivity to physical/visual/auditory stimuli, oversedation

RECTAL:

• Very common (10% or more): Somnolence (up to 23%)
• Common (1% to 10%): Ataxia, anterograde amnesia, convulsion, disrupted sensory perception, dizziness, drowsiness, dysarthria, epileptic attacks, hangover effect, headache, impaired motor ability, incoordination, reduced alertness, sedation, slurred speech, speech disorder, tremor, vertigo
• Uncommon (0.1% to 1%): Balance disorders, concentration difficulties
• Rare (0.01% to 0.1%): Dystonic effects, lightheadedness, memory loss, syncope, unconsciousness
• Frequency not reported: Grand mal convulsion, hyperkinesia, lethargy, minor changes in EEG patterns, nystagmus^[Ref]

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:

• Common (1% to 10%): Aggression/aggressiveness, anxiety, confusion, delirium, irritability, panic, paranoid psychosis, withdrawal symptoms
• Uncommon (0.1% to 1%): Depression, changed/increased/reduced libido
• Rare (0.01% to 0.1%): Agitation, delusion, emotional poverty, excitation, hallucinations, inappropriate behavior, insomnia, nightmares, other adverse behavioral effects, psychiatric reactions, psychoses, rages, restlessness
• Frequency not reported: Acute hyperexcittion/acute hyperexcited states, broken sleep with vivid dreams, confusional psychosis, delirium tremens, increased REM sleep, numbed emotions, physical dependence, sleep disturbances, stimulation, unmasked depression

PARENTERAL:

• Common (1% to 10%): Aggression/aggressiveness, anxiety, confusion, delirium, dependence, irritability, panic, paranoid psychosis, withdrawal symptoms
• Uncommon (0.1% to 1%): Acute hyperexcittion/acute hyperexcited states, auditory/visual hallucinations, numbed emotion, sleep disturbances, stimulation, suicidal ideation
• Rare (0.01% to 0.1%): Agitation, delusion, depression/mental depression, emotional poverty, excitation, hallucinations, inappropriate behavior, increased/changed/reduced libido, insomnia, nightmares, other adverse behavioral effects, psychiatric reactions, psychoses, rages, restlessness
• Frequency not reported: Broken sleep with vivid dreams, confusional psychoses, delirium tremens, disinhibition, dysphoria, euphoria, habituation, hypoactivity, increased REM sleep, inhibition of female orgasm, unmasked depression

RECTAL:

• Common (1% to 10%): Aggression/aggressiveness, agitation, anxiety, confusion, delirium, emotional lability, euphoria, irritability, nervousness, numbed emotions, panic, paranoid psychosis, thinking abnormal, uneasiness, unmasked depression, withdrawal symptoms
• Rare (0.01% to 0.1%): Delusion, emotional poverty, excitation, hallucination, inappropriate behavior, increased/reduced libido, insomnia, libido fluctuations, nightmares, other adverse behavioral effects, psychiatric reactions, psychoses, rage, restlessness
• Frequency not reported: Abuse, acute hyperexcited states, changes in libido, depression, drug dependence, dysphoria, instability, sleep disturbances, stimulation, uncovering of depression with suicidal tendencies^[Ref]

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:

• Uncommon (0.1% to 1%): Respiratory depression
• Rare (0.01% to 0.1%): Increased bronchial secretion, respiratory arrest
• Frequency not reported: Apnea

PARENTERAL:

• Uncommon (0.1% to 1%): Coughing, dyspnea, hyperventilation, laryngospasm, respiratory depression, throat pain
• Rare (0.01% to 0.1%): Increased bronchial secretion, respiratory arrest
• Frequency not reported: Apnea, hiccups

RECTAL:

• Common (1% to 10%): Asthma, hiccup, rhinitis
• Uncommon (0.1% to 1%): Respiratory depression
• Rare (0.01% to 0.1%): Apnea, increased bronchial secretion, laryngeal spasm, respiratory arrest
• Frequency not reported: Cough increased, hypoventilation^[Ref]

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:

• Common (1% to 10%): Fatigue, general malaise
• Rare (0.01% to 0.1%): Paradoxical reactions
• Frequency not reported: Accidents, falls, rebound effect, tinnitus

PARENTERAL:

• Common (1% to 10%): Fatigue, general malaise
• Uncommon (0.1% to 1%): Body pain, hyperpyrexia, hypothermia
• Rare (0.01% to 0.1%): Paradoxical reactions
• Frequency not reported: Pain

RECTAL:

• Common (1% to 10%): Falls, fatigue, general malaise, pain, paradoxical reactions
• Frequency not reported: Asthenia, lack of effect, rebound effect^[Ref]

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:

• Common (1% to 10%): Hypotension, palpitations
• Rare (0.01% to 0.1%): Bradycardia, heart failure (including cardiac arrest)
• Frequency not reported: Cardiovascular depression, chest pain, mild systolic hypertension, orthostatic hypotension, tachycardia

PARENTERAL:

• Common (1% to 10%): Palpitations
• Uncommon (0.1% to 1%): Bradycardia, cardiac arrest, chest pain, hypotension, other arrhythmias, tachycardia, ventricular premature contractions
• Frequency not reported: Mild systolic hypertension, orthostatic hypotension

RECTAL:

• Common (1% to 10%): Hypotension, palpitations, vasodilation
• Rare (0.01% to 0.1%): Bradycardia, chest pain, heart failure (including cardiac arrest)
• Frequency not reported: Cardiovascular collapse^[Ref]

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:

• Common (1% to 10%): Local irritation, pain, phlebitis, swelling, venous thrombosis
• Uncommon (0.1% to 1%): Erythema, local pain, tenderness, vascular changes
• Frequency not reported: Ischemia, tissue necrosis^[Ref]

Musculoskeletal

ORAL:

• Common (1% to 10%): Muscle spasms, muscle weakness
• Uncommon (0.1% to 1%): Myasthenia
• Frequency not reported: Muscle twitching
• Postmarketing reports: Fractures

PARENTERAL:

• Common (1% to 10%): Muscle spasms/increased muscle spasticity, muscle weakness
• Uncommon (0.1% to 1%): Increased phosphokinase activity, joint pain, muscle cramps, myasthenia
• Frequency not reported: Muscle aches, muscle twitching
• Postmarketing reports: Fractures

RECTAL:

• Common (1% to 10%): Muscle spasms, muscle weakness
• Uncommon (0.1% to 1%): Myasthenia
• Frequency not reported: Increased muscle spasticity, muscle cramps^[Ref]

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:

• Common (1% to 10%): Gastrointestinal disorders
• Uncommon (0.1% to 1%): Constipation, diarrhea, dry mouth, hypersalivation, increased salivary secretion, nausea, vomiting
• Frequency not reported: Abdominal cramps

PARENTERAL:

• Common (1% to 10%): Gastrointestinal disorders
• Uncommon (0.1% to 1%): Constipation, decreased gag reflex, diarrhea, hypersalivation, increased salivary secretion, nausea, vomiting
• Rare (0.01% to 0.1%): Dry mouth
• Frequency not reported: Abdominal cramps, changes in salivation

RECTAL:

• Common (1% to 10%): Abdominal pain, diarrhea, gastrointestinal disorders
• Uncommon (0.1% to 1%): Changes in salivation, constipation, increased salivary secretion, nausea, vomiting
• Rare (0.01% to 0.1%): Dry mouth, epigastric pain, obstipation
• Frequency not reported: Abdominal cramps^[Ref]

Increased salivation has been reported, especially in pediatric patients.

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

Metabolic

ORAL:

• Common (1% to 10%): Loss of appetite
• Uncommon (0.1% to 1%): Increased appetite
• Rare (0.01% to 0.1%): Alkaline phosphatase elevations

PARENTERAL:

• Common (1% to 10%): Loss of appetite
• Rare (0.01% to 0.1%): Alkaline phosphatase elevations, increased appetite

RECTAL:

• Common (1% to 10%): Loss of appetite
• Rare (0.01% to 0.1%): Alkaline phosphatase elevations, increased appetite
• Frequency not reported: Anorexia^[Ref]

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

Dermatologic

ORAL:

• Common (1% to 10%): Sweating
• Uncommon (0.1% to 1%): Allergic skin reactions, erythema, itching, rash/skin rash
• Frequency not reported: Perspiration

PARENTERAL:

• Uncommon (0.1% to 1%): Allergic skin reactions, erythema, itching, photosensitivity, pruritus, rash/skin rash, urticaria
• Frequency not reported: Perspiration, Steven-Johnson syndrome, sweating

RECTAL:

• Common (1% to 10%): Rash, sweating
• Uncommon (0.1% to 1%): Allergic skin reactions, erythema, itching
• Very rare (less than 0.01%): Urticaria
• Frequency not reported: Pruritus^[Ref]

Sweating occurred in patients with withdrawal symptoms.^[Ref]

Ocular

ORAL:

• Uncommon (0.1% to 1%): Blurred vision, diplopia
• Frequency not reported: Nystagmus, reversible visual disorders, visual disturbances

PARENTERAL:

• Uncommon (0.1% to 1%): Blurred vision, conjunctivitis, diplopia, nystagmus
• Frequency not reported: Reversible visual disorders, visual disturbances

RECTAL:

• Common (1% to 10%): Double vision/diplopia
• Rare (0.01% to 0.1%): Other visual disturbances
• Frequency not reported: Blurred vision, mydriasis, nystagmus, reversible visual disorders^[Ref]

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

Hematologic

ORAL:

• Rare (0.01% to 0.1%): Blood dyscrasias
• Very rare (less than 0.01%): Leukopenia, neutropenia

PARENTERAL:

• Uncommon (0.1% to 1%): Agranulocytosis, anemia, blood dyscrasias, leukopenia, neutropenia, thrombocytopenia

RECTAL:

• Rare (0.01% to 0.1%): Blood dyscrasias, thrombocytopenia
• Very rare (less than 0.01%): Leukopenia
• Frequency not reported: Anemia, neutropenia, lymphadenopathy^[Ref]

Genitourinary

ORAL:

• Uncommon (0.1% to 1%): Incontinence, urinary retention
• Rare (0.01% to 0.1%): Impotence

PARENTERAL:

• Uncommon (0.1% to 1%): Difficulty in micturition
• Rare (0.01% to 0.1%): Impotence, incontinence, urinary retention
• Frequency not reported: Galactorrhea

RECTAL:

• Rare (0.01% to 0.1%): Impotence, incontinence, menstrual disturbances, urinary retention
• Frequency not reported: Urinary tract infection^[Ref]

Hepatic

ORAL:

• Rare (0.01% to 0.1%): Changes of hepatic parameters, elevation of ALT or AST, jaundice

PARENTERAL:

• Uncommon (0.1% to 1%): Hepatic dysfunction, jaundice
• Rare (0.01% to 0.1%): Changes of hepatic parameters, elevation of ALT or AST
• Frequency not reported: Cholestasis

RECTAL:

• Rare (0.01% to 0.1%): Changes of hepatic parameters, cholestatic jaundice, elevation of ALT or AST, hepatocellular jaundice, jaundice^[Ref]

Hypersensitivity

ORAL:

• Rare (0.01% to 0.1%): Anaphylaxis, hypersensitivity reactions

PARENTERAL:

• Uncommon (0.1% to 1%): Immediate hypersensitivity reactions
• Rare (0.01% to 0.1%): Anaphylaxis

RECTAL:

• Very rare (less than 0.01%): Anaphylaxis, angioedema^[Ref]

Renal

PARENTERAL:

• Uncommon (0.1% to 1%): Increased serum creatinine^[Ref]

Endocrine

ORAL:

• Rare (0.01% to 0.1%): Gynecomastia

PARENTERAL:

• Rare (0.01% to 0.1%): Gynecomastia
• Frequency not reported: Increased plasma testosterone levels, increased prolactin levels

RECTAL:

• Rare (0.01% to 0.1%): Gynecomastia^[Ref]

Further information

Diastat 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.

Medical Disclaimer