Diastat AcuDial Side Effects

Generic Name: diazepam

Please note - some side effects for Diastat AcuDial may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Diastat AcuDial - for the Consumer

Diastat AcuDial Gel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Diastat AcuDial Gel:

Decreased coordination; diarrhea; dizziness; drowsiness; headache; nervousness; stomach pain; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; hallucinations; mental or mood changes; muscle spasms or twitching; new or worsened seizures; overexcitement; shortness of breath; sleep disturbances; trouble sleeping; wheezing.

Side Effects by Body System

Nervous system

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.

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.

Local

One recent study has reported that a palpable venous cord was present in as many as 23% of patients treated with intravenous diazepam.

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.)

Respiratory

Respiratory arrest may occur, especially with parenteral administration of diazepam. Equipment for resuscitation should be immediately available when parenteral diazepam is used.

Diazepam, particularly when given by parenteral routes of administration may decrease the sensitivity of upper airway reflexes and thereby increase the risk of aspiration.

Other

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.

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.

Gastrointestinal

Gastrointestinal effects include constipation, gastrointestinal disturbances, and nausea. Changes in salivation have also been reported including dry mouth and hypersalivation.

Genitourinary

Genitourinary effects such as sexual dysfunction, incontinence, changes in libido, and urinary retention have been reported.

Hypersensitivity

Hypersensitivity side effects including rash, pruritus, and severe bronchospasm have been rarely reported.

Hepatic

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.

Hematologic

Neutropenia has been rarely reported. Periodic monitoring of blood counts may be useful in patients on long term diazepam therapy.

Endocrine

Endocrine side effects including a single case of gynecomastia has been reported in association with diazepam therapy.

Musculoskeletal

Musculoskeletal side effects have included increased muscle spasticity. One case report has suggested that diazepam may contribute to rhabdomyolysis in patients with hyponatremia.

Cardiovascular

Cardiovascular effects of diazepam including hypotension and possible anti-ischemic effects by reducing myocardial oxygen consumption have been reported.

Ocular

Ocular side effects including blurred vision and diplopia have been reported. A case of maculopathy has also been reported.

Other

A case of acute febrile neutrophilic dermatosis (Sweet's syndrome) has been reported consisting of an acute painful rash, high fever, and severe arthralgias.

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