Diastat Side Effects

Generic Name: diazepam

Please note - some side effects for Diastat 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 - 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.

Diastat 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 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.

Diastat Side Effects - for the Professional

Diastat

Diazepam rectal gel adverse event data were collected from double-blind, placebo-controlled studies and open-label studies. The majority of adverse events were mild to moderate in severity and transient in nature.

Two patients who received Diazepam rectal gel died seven to 15 weeks following treatment; neither of these deaths was deemed related to Diazepam rectal gel.

The most frequent adverse event reported to be related to Diazepam rectal gel in the two double-blind, placebo-controlled studies was somnolence (23%). Less frequent adverse events were dizziness, headache, pain, abdominal pain, nervousness, vasodilatation, diarrhea, ataxia, euphoria, incoordination, asthma, rhinitis, and rash, which occurred in approximately 2-5% of patients.

Approximately 1.4% of the 573 patients who received Diazepam rectal gel in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse event most frequently associated with discontinuation (occurring in three patients) was somnolence. Other adverse events most commonly associated with discontinuation and occurring in two patients were hypoventilation and rash. Adverse events occurring in one patient were asthenia, hyperkinesia, incoordination, vasodilatation and urticaria. These events were judged to be related to diazepam rectal gel.

In the two domestic double-blind, placebo-controlled, parallel-group studies, the proportion of patients who discontinued treatment because of adverse events was 2% for the group treated with Diazepam rectal gel, versus 2% for the placebo group. In the Diazepam rectal gel group, the adverse events considered the primary reason for discontinuation were different in the two patients who discontinued treatment; one discontinued due to rash and one discontinued due to lethargy. The primary reason for discontinuation in the patients treated with placebo was lack of effect.

Adverse Event Incidence in Controlled Clinical Trials

Table 1 lists treatment-emergent signs and symptoms that occurred in > 1% of patients enrolled in parallel-group, placebo-controlled trials and were numerically more common in the Diazepam rectal gel group. Adverse events were usually mild or moderate in intensity.

The prescriber should be aware that these figures, obtained when Diazepam rectal gel was added to concurrent antiepileptic drug therapy, cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.

Other events reported by 1% or more of patients treated in controlled trials but equally or more frequent in the placebo group than in the Diazepam rectal gel group were abdominal pain, pain, nervousness, and rhinitis. Other events reported by fewer than 1% of patients were infection, anorexia, vomiting, anemia, lymphadenopathy, grand mal convulsion, hyperkinesia, cough increased, pruritus, sweating, mydriasis, and urinary tract infection.

The pattern of adverse events was similar for different age, race and gender groups.

Other Adverse Events Observed During All Clinical Trials

Diazepam rectal gel has been administered to 573 patients with epilepsy during all clinical trials, only some of which were placebo-controlled. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified COSTART dictionary terminology. These categories are used in the listing below. All of the events listed below occurred in at least 1% of the 573 individuals exposed to Diazepam rectal gel.

All reported events are included except those already listed above, events unlikely to be drug-related, and those too general to be informative. Events are included without regard to determination of a causal relationship to diazepam.

BODY AS A WHOLE: Asthenia

CARDIOVASCULAR: Hypotension, vasodilatation

NERVOUS: Agitation, confusion, convulsion, dysarthria, emotional lability, speech disorder, thinking abnormal, vertigo

RESPIRATORY: Hiccup

The following infrequent adverse events were not seen with Diazepam rectal gel but have been reported previously with diazepam use: depression, slurred speech, syncope, constipation, changes in libido, urinary retention, bradycardia, cardiovascular collapse, nystagmus, urticaria, neutropenia and jaundice.

Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported with diazepam; should these occur, use of Diazepam rectal gel should be discontinued.

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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