Psychiatric side effects have included stimulation, restlessness, acute hyperexcited states, anxiety, agitation, aggressiveness, irritability, rage, hallucinations, psychoses, delusions, insomnia, sleep disturbances, and nightmares. Inappropriate behavior and other adverse behavioral effects have been reported when using benzodiazepines.
Approval History Calendar Drug history at FDA.
Ocular side effects including blurred vision and diplopia have been reported. A case of maculopathy has also been reported.
Should these occur, use of the drug should be discontinued. These side effects are more likely to occur in children and in the elderly.
Dermatologic side effects including skin reactions have been reported.
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One recent study has reported that a palpable venous cord was present in as many as 23% of patients treated with intravenous diazepam.
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.
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.
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Local reactions at the site of injection (such as venous thrombosis, phlebitis, local irritation and swelling) occur in about 8% of patients. Rarely, vascular impairment has occurred, sometimes with severe consequences. Diazepam emulsified injection (Dizac) has been associated with a lower frequency of thrombophlebitis and pain on injection. (Diazepam emulsified injection has been approved for intravenous use only.).
Endocrine side effects including a single case of gynecomastia has been reported in association with diazepam therapy.
A case of acute febrile neutrophilic dermatosis (Sweet's syndrome) has been reported consisting of an acute painful rash, high fever, and severe arthralgias.
Hypersensitivity side effects including rash, pruritus, and severe bronchospasm have been rarely reported.
Diazepam, particularly when given by parenteral routes of administration may decrease the sensitivity of upper airway reflexes and thereby increase the risk of aspiration.
Respiratory arrest may occur, especially with parenteral administration of diazepam. Equipment for resuscitation should be immediay available when parenteral diazepam is used.
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Genitourinary effects such as sexual dysfunction, incontinence, changes in libido, and urinary retention have been reported.
Gastrointestinal effects include constipation, gastrointestinal disturbances, and nausea. Changes in salivation have also been reported including dry mouth and hypersalivation.
Neutropenia has been rarely reported. Periodic monitoring of blood counts may be useful in patients on long term diazepam therapy.
Musculoskeletal side effects have included increased muscle spasticity. One case report has suggested that diazepam may contribute to rhabdomyolysis in patients with hyponatremia. There are postmarketing reports of falls and fractures in benzodiazepine users. The risk is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly.
Nervous system side effects are common and include drowsiness, fatigue, confusion, depression, psychomotor impairment, cognitive impairment, headache, syncope, slurred speech, tremor, vertigo, dysarthria, dizziness, and ataxia. Acute dystonic reactions and coma have been rarely reported.
Applies to diazepam: oral capsule extended release, oral solution, oral tablet Other dosage forms:
Data sources include Micromedex (updated Sep 26th, 2014), Cerner Multum (updated Oct 16th, 2014), Wolters Kluwer (updated Oct 9th, 2014) and others. To view content sources and attributions, refer to our editorial policy.
Some investigators have also suggested that the presence of psychosensory symptoms such as depersonalization, derealization, and perceptual distortion are a unique feature of the withdrawal syndrome. A recent study which confirmed that an increase in symptoms often accompanies withdrawal, concluded that withdrawal symptoms were neither intense nor excessively difficult for patients following discontinuation of low-dose diazepam.
CSA Schedule 4 Some potential for abuse.
Pregnancy Category N Not classified.
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Withdrawal symptoms after abrupt cessation of diazepam may include convulsions, tremor, abdominal cramps, panic attacks, depression, vomiting, anxiety, agitation, insomnia and sweating. Catatonia following benzodiazepine withdrawal has been reported in five patients, two of whom withdrew from diazepam.
You should check with your doctor immediay if any of these side effects occur when taking diazepam:
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 l 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:
One study has suggested that the acute pharmacodynamic profile of diazepam with respect to euphoria and subject liking is similar to barbiturates. Another study has suggested that long-term benzodiazepine therapy may be associated with significant cognitive impairments which may persist following benzodiazepine withdrawal. Cases of paradoxical reactions to diazepam (increased agitation and hyperactivity) have been reported rarely.
For Healthcare Professionals Applies to diazepam: injectable solution, intravenous suspension, oral capsule extended release, oral concentrate, oral solution, oral tablet, rectal kit.
Availability Rx Prescription only.
If any of the following symptoms of overdose occur while taking diazepam, get emergency help immediay:
Cardiovascular effects of diazepam including hypotension and possible anti-ischemic effects by reducing myocardial oxygen consumption have been reported.
Hepatic effects including granulomatous hepatitis have been reported. Elevated liver function tests have been rarely reported. Periodic monitoring of liver function tests is recommended for patients on long-term diazepam therapy, particularly for patients with preexisting liver disease.
Diazepam side effects