Zetran injection

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Do not drink alcohol shortly after receiving diazepam injection. Dangerous side effects or death could occur.

Diazepam injection can cause extreme drowsiness that may last for several hours after you have received the medication. Older adults may feel sleepy for even longer.

Avoid driving or doing anything that requires you to be awake and alert until the effects of this medicine have worn off completely.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• weak or shallow breathing;

• restlessness, feeling agitated or irritable;

• unusual thoughts, hallucinations; or

• a light-headed feeling, like you might pass out.

The sedative effects of diazepam may last longer in older adults. Accidental falls are common in elderly patients who use benzodiazepines. Use caution to avoid falling or accidental injury shortly after receiving diazepam injection.

Common side effects may include:

• drowsiness;

• tired feeling;

• muscle weakness, loss of coordination; or

• bruising or swelling around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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]

Some side effects of Zetran may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.