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Valrelease Side Effects

Generic Name: diazepam

Note: This page contains side effects data for the generic drug diazepam. It is possible that some of the dosage forms included below may not apply to the brand name Valrelease.

For the Consumer

Applies to diazepam: oral capsule extended release, oral solution, oral tablet

As well as its needed effects, diazepam (the active ingredient contained in Valrelease) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking diazepam, check with your doctor immediately:

More common:
  • Shakiness and unsteady walk
  • unsteadiness, trembling, or other problems with muscle control or coordination
Incidence not known:
  • Abdominal or stomach pain
  • agitation
  • anxiety
  • black, tarry stools
  • blistering, flaking, or peeling of skin
  • blurred vision
  • changes in patterns and rhythms of speech
  • chills
  • confusion
  • cough
  • dark urine
  • decrease in frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • discouragement
  • 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
  • fever
  • headache
  • hyperexcitability
  • increased muscle spasms or tone
  • irritability
  • itching
  • 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
  • nausea
  • nervousness
  • nightmares
  • outbursts of anger
  • painful or difficult urination
  • pale skin
  • rash
  • restlessness
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • sleeplessness
  • slurred speech
  • sore throat
  • sweating
  • trembling or shaking of the hands or feet
  • tremor
  • 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
  • sleepiness
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Minor Side Effects

Some diazepam side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Incidence not known:
  • Constipation
  • decreased interest in sexual intercourse
  • diarrhea
  • 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
  • indigestion
  • 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

One study has suggested that the acute pharmacodynamic profile of diazepam (the active ingredient contained in Valrelease) 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.[Ref]

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.[Ref]


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 Valrelease) [Ref]

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.)[Ref]


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.


Diazepam (the active ingredient contained in Valrelease) particularly when given by parenteral routes of administration may decrease the sensitivity of upper airway reflexes and thereby increase the risk of aspiration.[Ref]

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


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 Valrelease) [Ref]

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.[Ref]


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


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


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


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 Valrelease) therapy, particularly for patients with preexisting liver disease.[Ref]


Neutropenia has been rarely reported. Periodic monitoring of blood counts may be useful in patients on long term diazepam (the active ingredient contained in Valrelease) therapy.[Ref]


Endocrine side effects including a single case of gynecomastia has been reported in association with diazepam (the active ingredient contained in Valrelease) therapy.[Ref]


Musculoskeletal side effects have included increased muscle spasticity. One case report has suggested that diazepam (the active ingredient contained in Valrelease) 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.[Ref]


Cardiovascular effects of diazepam (the active ingredient contained in Valrelease) including hypotension and possible anti-ischemic effects by reducing myocardial oxygen consumption have been reported.[Ref]


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


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


Dermatologic side effects including skin reactions have been reported.


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32. Franco RC "Diazepam-associated Sweet's syndrome." Int J Dermatol 39 (2000): 795-8

It is possible that some side effects of Valrelease may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.