Note: This document contains side effect information about diazepam. Some dosage forms listed on this page may not apply to the brand name Valtoco.

Applies to diazepam: oral solution, oral tablet. Other dosage forms:

• injection solution
• nasal spray
• rectal gel/jelly

Serious side effects of Valtoco

Along with its needed effects, diazepam (the active ingredient contained in Valtoco) 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:

More common

• Shakiness and unsteady walk
• unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

• Agitation
• black, tarry stools
• blistering, flaking, or peeling of the skin
• blurred vision
• changes in patterns and rhythms of speech
• chills
• confusion
• cough
• dark urine
• decrease in the frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• discouragement
• 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
• fever
• headache
• hyperexcitability
• increased muscle spasms or tone
• irritability
• 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
• nausea
• nightmares
• outbursts of anger
• painful or difficult urination
• pale skin
• restlessness
• seizures
• slurred speech
• sore throat
• stomach pain
• sweating
• 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

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

Symptoms of overdose

• Agitation
• change in consciousness
• changes in patterns and rhythms of speech
• confusion
• difficult or trouble breathing
• excitement
• irregular, fast or slow, or shallow breathing
• irritability
• lack of coordination
• loss of consciousness
• loss of strength or energy
• muscle pain or weakness
• pale or blue lips, fingernails, or skin
• restlessness
• shakiness and unsteady walk
• sleepiness
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects of Valtoco

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:

Incidence not known

• Constipation
• decreased interest in sexual intercourse
• diarrhea
• 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
• indigestion
• loss of sexual ability, desire, drive, or performance
• passing of gas
• seeing double
• sensation of spinning

For Healthcare Professionals

Applies to diazepam: 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

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]

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]

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

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]

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]

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

Palpitations occurred in patients with withdrawal symptoms.

Thrombophlebitis and venous thrombosis have occurred with injection formulations.

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

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]

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

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]

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]

Gastrointestinal

Increased salivation has been reported, especially in pediatric patients.

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

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]

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

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

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]

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]