Valtoco Side Effects: What to Expect and When to Call Your Doctor

Valtoco (diazepam nasal spray) is generally well-tolerated as an intermittent rescue medication. However, like all benzodiazepines, it carries important side effects and warnings that patients, caregivers, and providers need to understand. This guide covers what to expect after using Valtoco and when to seek medical help.

Boxed Warning: Risks You Must Know Before Using Valtoco

Valtoco carries the FDA's most serious warning—a

Boxed Warning—covering three major risks:

Concomitant use with opioids: Using Valtoco with opioid medications (codeine, morphine, oxycodone, etc.) can cause profound sedation, respiratory depression, coma, and death. This combination should only be used when no alternative exists and must be monitored closely.

Abuse, misuse, and addiction: Diazepam, the active ingredient in Valtoco, is a Schedule IV controlled substance with potential for abuse and addiction. Taking it more frequently than prescribed increases this risk significantly.

Physical dependence and withdrawal: Although Valtoco is intended for intermittent use (not daily), misuse or more frequent use than prescribed can lead to physical dependence. Abrupt discontinuation can cause life-threatening withdrawal symptoms.

Common Side Effects of Valtoco

In clinical studies of 255 patients ages 2 and older, the most common side effects were:

Somnolence (drowsiness): The most common systemic side effect. After giving Valtoco, stay with the person and do not allow them to drive or operate machinery until fully awake and alert.

Headache: Reported in some patients, typically mild and transient.

Nasal discomfort: 5% of patients reported nasal discomfort—mild to moderate and local to the nasal spray administration.

Dysgeusia (altered taste): 2% of patients reported an altered or unusual taste sensation after administration.

Epistaxis (nosebleeds): 2% of patients reported nosebleeds associated with nasal administration.

Rhinorrhea (runny nose): 1% of patients reported a runny nose after use.

Serious Side Effects: When to Call Your Doctor or 911

Call 911 or go to the nearest emergency room immediately if you notice any of the following:

Difficulty breathing, slowed or stopped breathing, or blue/gray skin color

Excessive or extreme drowsiness that you cannot wake the person from

Seizures that don't stop or worsen after a second dose of Valtoco

Signs of a serious allergic reaction: hives, difficulty breathing, swelling of the face/lips/throat

New or worsening suicidal thoughts or behaviors (call your doctor or 988, the Suicide & Crisis Lifeline)

CNS Depression: What Caregivers Should Watch For

After administering Valtoco, caregivers should stay with the person and watch for:

Changes in breathing rate or depth

Changes in skin color (paleness, bluish tint)

Continued or worsening seizure activity

Extreme drowsiness or unresponsiveness

Write down the time Valtoco was given, the dose, and any observations. This information helps your healthcare provider assess the treatment.

Suicidal Thoughts and Antiepileptic Drugs

Like all antiepileptic drugs, Valtoco carries a small risk of suicidal thoughts or behaviors. Studies show this risk is approximately 1 in 500 patients. If you or a loved one experiences new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior after using Valtoco, contact your healthcare provider immediately.

Use in Special Populations

Certain populations should use Valtoco with extra caution:

Pregnancy: Based on animal data, Valtoco may cause fetal harm. Newborns of mothers who used benzodiazepines during late pregnancy may experience withdrawal symptoms. Discuss risks with your healthcare provider.

Breastfeeding: Diazepam is excreted in human milk. Infants exposed via breast milk may experience sedation, poor feeding, and poor weight gain.

Pediatric patients ages 2-5: Plasma concentrations in children ages 2–5 are approximately 2 times greater than in adults for the same dose. Close monitoring is essential.

Report Side Effects

You can report suspected adverse reactions to Neurelis at 1-866-696-3873 or to the FDA at 1-800-FDA-1088. For more on what medications to avoid with Valtoco, see: Valtoco Drug Interactions: What to Avoid and What to Tell Your Doctor.