Diazepam Intensol Side Effects
Generic Name: diazepam
Note: This page contains information about the side effects of diazepam. Some of the dosage forms included on this document may not apply to the brand name Diazepam Intensol.
Not all side effects for Diazepam Intensol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to diazepam: oral capsule extended release, oral solution, oral tablet
In addition to its needed effects, some unwanted effects may be caused by diazepam (the active ingredient contained in Diazepam Intensol). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking diazepam:More common
- Shakiness and unsteady walk
- unsteadiness, trembling, or other problems with muscle control or coordination
- Abdominal or stomach pain
- black, tarry stools
- blistering, flaking, or peeling of skin
- blurred vision
- changes in patterns and rhythms of speech
- dark urine
- decrease in frequency of urination
- decrease in urine volume
- difficulty in passing urine (dribbling)
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- 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
- increased muscle spasms or tone
- lack of appetite
- 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
- mood or other mental changes
- outbursts of anger
- painful or difficult urination
- pale skin
- shakiness in the legs, arms, hands, or feet
- shortness of breath
- slurred speech
- sore throat
- trembling or shaking of the hands or feet
- trouble concentrating
- trouble in speaking
- trouble sleeping
- ulcers, sores, or white spots in the mouth
- unable to sleep
- unpleasant breath odor
- unusual behavior
- unusual bleeding or bruising
- unusual feeling of excitement
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
If any of the following symptoms of overdose occur while taking diazepam, get emergency help immediately:Symptoms of overdose
- Change in consciousness
- difficult or troubled breathing
- irregular, fast or slow, or shallow breathing
- lack of coordination
- loss of consciousness
- loss of strength or energy
- muscle pain or weakness
- pale or blue lips, fingernails, or skin
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
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 tell 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:Incidence not known
- decreased interest in sexual intercourse
- difficulty in 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 mouth
- loss of sexual ability, desire, drive, or performance
- passing of gas
- seeing double
- sensation of spinning
For Healthcare Professionals
Applies to diazepam: injectable solution, intravenous suspension, oral capsule extended release, oral concentrate, oral solution, oral tablet, rectal kit
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.
One recent study has reported that a palpable venous cord was present in as many as 23% of patients treated with intravenous diazepam (the active ingredient contained in Diazepam Intensol)
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.)
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.
Should these occur, use of the drug should be discontinued. These side effects are more likely to occur in children and in the elderly.
Respiratory arrest may occur, especially with parenteral administration of diazepam (the active ingredient contained in Diazepam Intensol) 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.
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 (the active ingredient contained in Diazepam Intensol)
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 effects include constipation, gastrointestinal disturbances, and nausea. Changes in salivation have also been reported including dry mouth and hypersalivation.
Genitourinary effects such as sexual dysfunction, incontinence, changes in libido, and urinary retention have been reported.
Hypersensitivity side effects including rash, pruritus, and severe bronchospasm have been rarely 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 (the active ingredient contained in Diazepam Intensol) therapy, particularly for patients with preexisting liver disease.
Neutropenia has been rarely reported. Periodic monitoring of blood counts may be useful in patients on long term diazepam (the active ingredient contained in Diazepam Intensol) therapy.
Endocrine side effects including a single case of gynecomastia has been reported in association with diazepam (the active ingredient contained in Diazepam Intensol) therapy.
Musculoskeletal side effects have included increased muscle spasticity. One case report has suggested that diazepam (the active ingredient contained in Diazepam Intensol) 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.
Cardiovascular effects of diazepam (the active ingredient contained in Diazepam Intensol) including hypotension and possible anti-ischemic effects by reducing myocardial oxygen consumption have been reported.
Ocular side effects including blurred vision and diplopia have been reported. A case of maculopathy has also been reported.
A case of acute febrile neutrophilic dermatosis (Sweet's syndrome) has been reported consisting of an acute painful rash, high fever, and severe arthralgias.
Dermatologic side effects including skin reactions have been reported.
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