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Valtoco Side Effects

Generic name: diazepam

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 10, 2024.

Note: This document provides detailed information about Valtoco Side Effects associated with diazepam. Some dosage forms listed on this page may not apply specifically to the brand name Valtoco.

Applies to diazepam: rectal gel/jelly.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Rectal route (gel/jelly)

Risks From Concomitant use with Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal Reactions Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression.The use of benzodiazepines, including diazepam rectal gel, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death.

Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with increased frequency of serious adverse outcomes.

Before prescribing diazepam rectal gel and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.

The continued use of benzodiazepines may lead to clinically significant physical dependence.

The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose.

Although diazepam rectal gel is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of diazepam rectal gel may precipitate acute withdrawal reactions, which can be life-threatening.

For patients using diazepam rectal gel more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam rectal gel.

Serious side effects of Valtoco

Along with its needed effects, diazepam (the active ingredient contained in Valtoco) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking diazepam:

Less common

  • anxiety
  • blurred vision
  • changes in patterns and rhythms of speech
  • chest tightness
  • confusion
  • cough
  • crying
  • delusions
  • dementia
  • depersonalization
  • difficulty breathing
  • difficulty in speaking
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • dysphoria
  • false or unusual sense of well-being
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • irregular heartbeat
  • irritability
  • lack of coordination
  • mental depression
  • mood or mental changes
  • nervousness
  • noisy breathing
  • paranoia
  • quick to react or overreact emotionally
  • rapidly changing moods
  • restlessness
  • seizures
  • shakiness and unsteady walk
  • slurred speech
  • sweating
  • trouble breathing
  • trouble in speaking
  • trouble sleeping
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual tiredness or weakness

Rare

  • bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • fever or chills
  • frequent urge to urinate
  • increase in body movements
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur while taking diazepam:

Symptoms of overdose

Other side effects of Valtoco

Some side effects of diazepam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • diarrhea
  • feeling of constant movement of self or surroundings
  • hiccups
  • lack or loss of strength
  • rash
  • runny or stuffy nose
  • sensation of spinning
  • sneezing

Rare

  • bigger, dilated, or enlarged pupils (black part of eye)
  • increased sensitivity of the eyes to light
  • itching skin
  • loss of appetite
  • vomiting
  • weight loss

For healthcare professionals

Applies to diazepam: buccal film, compounding powder, injectable solution, intravenous suspension, nasal spray, oral capsule extended release, oral concentrate, oral solution, oral tablet, rectal kit.

General

ORAL: The most commonly reported side effects included ataxia, drowsiness, fatigue, and muscle weakness.

PARENTERAL: The most commonly reported side effects included fatigue, drowsiness, ataxia, injection-site venous thrombosis, and injection-site phlebitis.

RECTAL: The most commonly reported side effects included somnolence, headache, and diarrhea.[Ref]

Nervous system

ORAL:

PARENTERAL:

RECTAL:

Drowsiness, headache, dizziness, ataxia, and reduced alertness occurred at the start of treatment, but usually disappeared with continued use.

Anterograde amnesia is a dose-related side effect that may occur at therapeutic doses.

Tremor, disrupted sensory perception, and epileptic attacks occurred in patients with withdrawal symptoms.

Drowsiness, sedation, unsteadiness, and ataxia are dose-related and may persist into the following day, even with single doses.

Prolonged use of treatment in elderly patients may result in dementia.[Ref]

Psychiatric

ORAL:

PARENTERAL:

RECTAL:

Confusion and numbed emotions occurred at the start of treatment, but usually disappeared with continued use. Confusion has occurred in elderly patients who received high doses.

Inappropriate behavior may occur with anterograde amnesia.

Psychic and physical dependence occurred with chronic use at therapeutic doses; withdrawal symptoms may occur in patients with dependence when treatment is discontinued.

Anxiety, panic, irritability, aggressiveness/aggression, paranoid psychosis, and delirium occurred in patients with withdrawal symptoms.

Restlessness, agitation, irritability, aggressiveness/aggression, rage, delusions, nightmares, psychoses, hallucinations, and inappropriate behavior occurred in patients with paradoxical reactions, especially in elderly and pediatric patients.

Increased REM sleep and broken sleep with vivid dreams may persist for weeks after treatment is discontinued.[Ref]

Respiratory

ORAL:

PARENTERAL:

RECTAL:

Increased bronchial secretions were reported, especially in pediatric patients.

Respiratory depression and apnea occurred, especially with high doses.

Coughing, respiratory depression, dyspnea, hyperventilation, laryngospasm, and throat/chest pain have been reported in patients undergoing peroral endoscopic procedures.[Ref]

Other

ORAL:

PARENTERAL:

RECTAL:

Fatigue occurred at the start of treatment, but usually disappeared with continued use.

Elderly patients have an increased risk of falling.

Patients with physical/psychic dependence may experience rebound effects during discontinuation.

General malaise occurred in patients with withdrawal symptoms.

Pain occurred with injection formulations.[Ref]

Cardiovascular

ORAL:

PARENTERAL:

RECTAL:

Palpitations occurred in patients with withdrawal symptoms.

Thrombophlebitis and venous thrombosis have occurred with injection formulations.

Ischemia occurred with inadvertent intra-arterial administration.[Ref]

Local

PARENTERAL:

Musculoskeletal

ORAL:

PARENTERAL:

RECTAL:

Muscle weakness occurred at the start of treatment, but usually disappeared with continued use.

Elderly patients and/or those taking sedatives/alcohol concomitantly have an increased risk of fractures associated with falls.

Muscle spasms occurred in patients with withdrawal symptoms.

Tissue necrosis occurred with inadvertent intra-arterial administration.[Ref]

Gastrointestinal

ORAL:

PARENTERAL:

RECTAL:

Increased salivation has been reported, especially in pediatric patients.

Gastrointestinal disorders occurred in patients with withdrawal symptoms.[Ref]

Metabolic

ORAL:

PARENTERAL:

RECTAL:

Appetite loss occurred in patients with withdrawal symptoms.[Ref]

Dermatologic

ORAL:

PARENTERAL:

RECTAL:

Sweating occurred in patients with withdrawal symptoms.[Ref]

Ocular

ORAL:

PARENTERAL:

RECTAL:

Double vision occurred at the start of treatment, but usually disappeared with continued use.[Ref]

Hematologic

ORAL:

PARENTERAL:

RECTAL:

Genitourinary

ORAL:

PARENTERAL:

RECTAL:

Hepatic

ORAL:

PARENTERAL:

RECTAL:

Hypersensitivity

ORAL:

PARENTERAL:

RECTAL:

Renal

PARENTERAL:

Endocrine

ORAL:

PARENTERAL:

RECTAL:

References

1. (2002) "Product Information. Valium (diazepam)." Roche Laboratories

2. (2001) "Product Information. Dizac (diazepam)." OHMEDA

3. (2001) "Product Information. Diastat (diazepam)." Athena Neurosciences Inc

4. Cerner Multum, Inc. "UK Summary of Product Characteristics."

5. Cerner Multum, Inc. "Australian Product Information."

Frequently asked questions

Further information

Valtoco side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.