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Diazepam Side Effects

In Summary

Commonly reported side effects of diazepam include: drowsiness and hypotonia. 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. 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
Incidence not known:
  • Abdominal or stomach pain
  • agitation
  • anxiety
  • black, tarry stools
  • blistering, flaking, or peeling of skin
  • blurred vision
  • changes in patterns and rhythms of speech
  • chills
  • confusion
  • cough
  • dark urine
  • decrease in frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • 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
  • fever
  • headache
  • hyperexcitability
  • increased muscle spasms or tone
  • irritability
  • itching
  • lack of appetite
  • 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
  • mood or other mental changes
  • nausea
  • nervousness
  • nightmares
  • outbursts of anger
  • painful or difficult urination
  • pale skin
  • rash
  • restlessness
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • sleeplessness
  • slurred speech
  • sore throat
  • sweating
  • trembling or shaking of the hands or feet
  • tremor
  • trouble concentrating
  • trouble in speaking
  • trouble sleeping
  • ulcers, sores, or white spots in the mouth
  • unable to sleep
  • 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
  • sleepiness
  • 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:
  • Constipation
  • decreased interest in sexual intercourse
  • diarrhea
  • difficulty in 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 mouth
  • indigestion
  • 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

General

The most commonly reported side effects include sedation/drowsiness, ataxia, and muscle weakness.[Ref]

Nervous system

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]

Psychiatric

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]

Other

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]

Gastrointestinal

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]

Dermatologic

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]

Cardiovascular

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]

Respiratory

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]

Musculoskeletal

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]

Ocular

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]

Metabolic

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]

Genitourinary

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]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic skin reactions
Very rare (less than 0.01%): Anaphylaxis
Frequency not reported: Angioedema[Ref]

Hepatic

Rare (0.01% to 0.1%): Jaundice, cholestatic/hepatocellular jaundice, cholestasis, changes of hepatic parameters/increased ALT, AST, and alkaline phosphatase[Ref]

Hematologic

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

Endocrine

Rare (0.01% to 0.1%): Gynecomastia
Frequency not reported: Increased prolactin and testosterone levels[Ref]

References

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 diazepam 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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