Diastat Pediatric Side Effects
Generic Name: diazepam
Note: This page contains information about the side effects of diazepam. Some of the dosage forms included on this document may not apply to the brand name Diastat Pediatric.
Common side effects of Diastat Pediatric include: drowsiness. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to diazepam: oral capsule extended release, oral solution, oral tablet
In addition to its needed effects, some unwanted effects may be caused by diazepam (the active ingredient contained in Diastat Pediatric). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking diazepam:More common:
- Shakiness and unsteady walk
- unsteadiness, trembling, or other problems with muscle control or coordination
- Abdominal or stomach pain
- black, tarry stools
- blistering, flaking, or peeling of the skin
- blurred vision
- changes in patterns and rhythms of speech
- dark urine
- decrease in the frequency of urination
- decrease in urine volume
- difficulty in passing urine (dribbling)
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- false beliefs that cannot be changed by facts
- fast heartbeat
- fast or irregular breathing
- feeling sad or empty
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- feeling, seeing, or hearing things that are not there
- increased muscle spasms or tone
- itching or rash
- lack of memory of what takes place after a certain event
- loss of appetite
- loss of bladder control
- loss of interest or pleasure
- lower back or side pain
- outbursts of anger
- painful or difficult urination
- pale skin
- slurred speech
- sore throat
- trouble concentrating
- trouble sleeping
- trouble speaking
- ulcers, sores, or white spots in the mouth
- unpleasant breath odor
- unusual behavior
- unusual bleeding or bruising
- unusual feeling of excitement
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
If any of the following symptoms of overdose occur while taking diazepam, get emergency help immediately:Symptoms of overdose:
- Change in consciousness
- difficult or troubled breathing
- irregular, fast or slow, or shallow breathing
- lack of coordination
- loss of consciousness
- loss of strength or energy
- muscle pain or weakness
- pale or blue lips, fingernails, or skin
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Minor Side Effects
Some of the side effects that can occur with diazepam may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:Incidence not known:
- decreased interest in sexual intercourse
- difficulty with swallowing
- double vision
- dry mouth
- feeling of constant movement of self or surroundings
- inability to have or keep an erection
- increase in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased watering of the mouth
- loss of sexual ability, desire, drive, or performance
- passing of gas
- seeing double
- sensation of spinning
For Healthcare Professionals
Applies to diazepam: injectable solution, intravenous suspension, oral capsule extended release, oral concentrate, oral solution, oral tablet, rectal kit
The most commonly reported side effects include sedation/drowsiness, ataxia, and muscle weakness.[Ref]
Very common (10% or more): Drowsiness/somnolence (up to 23%)
Common (1% to 10%): Anterograde amnesia/amnesia, ataxia, nervousness, unsteadiness, incoordination, impaired motor ability, hyperkinesia, tremor, epileptic attacks, sedation, headache, dizziness, slurred speech, hangover effect, decreased/reduced alertness, disrupted sensory perception
Uncommon (0.1% to 1%): Concentration difficulties, balance disorder
Rare (0.01% to 0.1%): Memory loss, dysarthria, syncope, unconsciousness, nystagmus, convulsions/grand mal convulsions, vertigo, lightheadedness, dystonia/dystonic effects, extrapyramidal effects, abnormal taste, hypersensitivity to physical, visual, and auditory stimuli
Frequency not reported: Oversedation, dementia, lethargy, minor EEG pattern changes
Postmarketing reports: Speech disorder[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]
Common (1% to 10%): Confusion, withdrawal symptoms, euphoria, increased anxiety/anxiety, panic, irritability, delirium, aggressiveness/aggression, numbed emotions, instability, restlessness, agitation, inappropriate behavior, delusions, rage, hallucinations, nightmares, confusional or paranoid psychosis/psychoses
Rare (0.01% to 0.1%): Excitation, insomnia, hostility, disinhibition, emotional poverty, other adverse behavioral effects, delirium tremens-like state, broken sleep with vivid dreams, increased REM sleep, increased or decreased libido
Frequency not reported: Drug abuse, unmasking of depression, inhibited female orgasm, acute hyperexcited states, stimulation, hypoactivity, physical and psychic dependence
Postmarketing reports: Emotional lability, abnormal thinking[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]
Common (1% to 10%): Fatigue, general malaise, paradoxical reactions, asthenia
Frequency not reported: Falls, rebound effect, tinnitus, pain, infection[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]
Increased salivation has been reported, especially in pediatric patients.
Gastrointestinal disorders occurred in patients with withdrawal symptoms.[Ref]
Common (1% to 10%): Gastrointestinal disorders/disturbances, abdominal pain, diarrhea
Uncommon (0.1% to 1%): Nausea, vomiting, constipation, dry mouth, increased salivary secretion/hypersalivation
Rare (0.01% to 0.1%): Obstipation, epigastric pain, abdominal cramps[Ref]
Sweating occurred in patients with withdrawal symptoms.[Ref]
Common (1% to 10%): Sweating, rash
Uncommon (0.1% to 1%): Itching/pruritus, erythema
Very rare (less than 0.01%): Urticaria
Frequency not reported: Steven-Johnson syndrome, skin reactions[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]
Common (1% to 10%): Palpitations, vasodilation
Uncommon (0.1% to 1%): Hypotension
Rare (0.01% to 0.1%): Bradycardia, mild systolic hypertension, tachycardia, orthostatic hypotension, chest pain, heart failure and cardiac arrest
Frequency not reported: Thrombophlebitis, venous thrombosis, ischemia, cardiovascular collapse[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]
Common (1% to 10%): Asthma, rhinitis
Uncommon (0.1% to 1%): Respiratory depression
Rare (0.01% to 0.1%): Respiratory arrest, increased bronchial secretion, laryngeal spasm/laryngospasm, apnea
Frequency not reported: Hypoventilation, increased cough, hiccups, dyspnea, hyperventilation, throat and chest pain[Ref]
Common (1% to 10%): Muscle spasms/increased muscle spasticity, muscle weakness
Uncommon (0.1% to 1%): Myasthenia
Rare (0.01% to 0.1%): Muscle twitching
Frequency not reported: Fractures, tissue necrosis, muscle aches and 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]
Common (1% to 10%): Double vision/diplopia
Rare (0.01% to 0.1%): Blurred vision, other visual disturbances/reversible disorders of vision
Frequency not reported: Mydriasis[Ref]
Double vision occurred at the start of treatment, but usually disappeared with continued use.[Ref]
Common (1% to 10%): Appetite loss
Rare (0.01% to 0.1%): Increased appetite
Frequency not reported: Anorexia[Ref]
Appetite loss occurred in patients with withdrawal symptoms.[Ref]
Uncommon (0.1% to 1%): Urinary retention, incontinence
Rare (0.01% to 0.1%): Impotence, menstrual changes
Frequency not reported: Galactorrhea, urinary tract infection[Ref]
Uncommon (0.1% to 1%): Allergic skin reactions
Very rare (less than 0.01%): Anaphylaxis
Frequency not reported: Angioedema[Ref]
Rare (0.01% to 0.1%): Jaundice, cholestatic/hepatocellular jaundice, cholestasis, changes of hepatic parameters/increased ALT, AST, and alkaline phosphatase[Ref]
Rare (0.01% to 0.1%): Blood dyscrasias, thrombocytopenia
Very rare (less than 0.01%): Leukopenia, neutropenia
Frequency not reported: Agranulocytosis, lymphadenopathy, anemia[Ref]
Rare (0.01% to 0.1%): Gynecomastia
Frequency not reported: Increased prolactin and testosterone levels[Ref]
1. "Product Information. Dizac (diazepam)." Ohmeda Pharmaceutical Products Division, Liberty Corner, NJ.
2. "Product Information. Valium (diazepam)." Roche Laboratories, Nutley, NJ.
3. "Product Information. Diastat (diazepam)." Athena Neurosciences Inc, South San Francisco, CA.
4. Cerner Multum, Inc. "Australian Product Information." O 0
5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
Not all side effects for Diastat Pediatric may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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- Drug class: benzodiazepine anticonvulsants
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