Diastat (diazepam) is a brand-name rectal gel that’s prescribed for seizures in certain adults and children. As with other drugs, Diastat can cause side effects. These include sleepiness, dizziness, and diarrhea.

Diastat belongs to a drug class called benzodiazepines. The drug is available in a generic version.

Diastat and Diastat AcuDial can be prescribed to adults and children 2 years and older. They are approved to treat seizures in certain people with refractory epilepsy.

Diastat and Diastat AcuDial are both available as a gel inside of a prefilled syringe. However, Diastat AcuDial can be dialed to the necessary dose of medication. Both forms of the drug are given rectally.

The rest of this article uses the name Diastat to refer to the drug. “AcuDial” will refer to the special syringe used to administer the drug.

Read on to learn about potential common, mild, and serious side effects of Diastat. For a general overview of the drug, including details about its uses, see this article.

Diastat can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who received Diastat in clinical trials:

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Diastat. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Diastat’s prescribing information.

Mild side effects that have been reported with Diastat include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while receiving Diastat and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after receiving Diastat. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the “Side effect specifics” section below.

Diastat may cause serious side effects. Although serious side effects are less common than mild side effects, you should be aware of the possibility of serious side effects occurring.

The list below may not include all possible serious side effects of the drug. For more information, you can refer to Diastat’s prescribing information.

If you develop serious side effects while receiving Diastat, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* Diastat has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effect specifics” section below.
† Diastat has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Diastat and misuse, withdrawal, and dependence” section below.
‡ An allergic reaction is possible after receiving Diastat. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the “Side effect specifics” section below.

Learn more about some of the side effects that Diastat may cause, including its boxed warning. To find out how often side effects occurred in clinical trials, see the prescribing information for Diastat.

Risk of serious harm if given with opioids

Diastat has a boxed warning for the risk of serious harm if the drug is given with an opioid medication. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts patients and prescribers about the risks of a medication.

Receiving Diastat while taking opioid drugs, such as Roxicodone (oxycodone), may cause serious harm. Specifically, treatment with these medications together can increase the risk of sleepiness, respiratory depression, and coma. In some cases, this may be life threatening.

What you can do

If you’re taking an opioid medication, talk with your doctor before they prescribe Diastat. Due to this risk, doctors typically will not prescribe Diastat for your seizures while you’re taking an opioid drug. However, they may be able to recommend a different treatment for your condition.

In some cases, your doctor may prescribe Diastat while you’re taking an opioid. This can depend on whether the opioid is for short- or long-term treatment.

If your doctor prescribes Diastat while you’re taking an opioid drug, they may prescribe low doses of both medications. They may also advise tapering off the opioid as safely and quickly as possible once your condition is treated.

In addition, your doctor will monitor you closely for symptoms of serious side effects. If you notice any serious side effects during your treatment, be sure to go to the hospital right away.

Sleepiness

Diastat may cause sleepiness. This was the most common side effect reported in the drug’s clinical trials.

In addition, sleepiness was also the most common reason that people stopped treatment with this medication.

What you can do

Tell your doctor if you experience sleepiness during your treatment with Diastat. Rarely, sleepiness may be caused by a more serious side effect, such as central nervous system depression.

It’s important to avoid certain activities until you know how Diastat will affect you. For example, you should avoid driving or operating heavy machinery after receiving your dose.

If you experience sleepiness that’s severe or bothersome after your Diastat dose, tell your doctor. They may recommend a different treatment option for you.

Headache

It’s possible for Diastat to cause a headache. However, this wasn’t a common side effect in the drug’s clinical trials.

What you can do

Tell your doctor if you experience a headache that’s severe or bothersome after your dose of Diastat. They can help determine the best way to manage this side effect. For example, they may recommend taking an over-the-counter medication, such as Tylenol (acetaminophen).

Allergic reaction

As with most drugs, Diastat can cause an allergic reaction in some people. However, it’s not clear whether this side effect occurred in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep receiving Diastat. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Tell your doctor about any medical conditions that you have or any medications that you take before they prescribe Diastat. They will help make sure that Diastat is a safe treatment option for you.

Boxed warnings

This drug has boxed warnings about the risks of misuse,addiction, withdrawal,dependence, and serious harm if given with opioids. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

For details on the risk of serious harm if given with opioids, see the “Side effect specifics” section above. For more information about misuse, addiction, withdrawal, and dependence, see the “Diastat and misuse, withdrawal, and dependence” section below.

Other precautions

Be sure to talk with your doctor about your health history before they prescribe Diastat. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Acute narrow-angle glaucoma. Diastat belongs to a class of drugs called benzodiazepines. As with other benzodiazepines, this drug may affect your eye muscles. Before starting treatment with Diastat, tell your doctor if you have acute narrow-angle glaucoma. If you have this condition, your doctor will likely not prescribe Diastat for your seizures.

Liver problems. Before your doctor prescribes Diastat, let them know about any liver problems you may have. Certain liver problems may increase the risk of side effects from this medication. Your doctor can help determine whether Diastat may be safe for you to receive. In some cases, they may recommend a different medication for your condition.

Breathing conditions. Before starting treatment with Diastat, tell your doctor if you have any breathing conditions, such as asthma or chronic obstructive pulmonary disorder (COPD). Diastat can cause respiratory depression and difficulty breathing. If you already have a condition that affects your breathing, Diastat may worsen it. Your doctor can help determine whether this medication is safe for your condition.

Allergic reaction. If you’ve had an allergic reaction to Diastat or any of its ingredients, your doctor will likely not prescribe Diastat. Ask your doctor what other medications may be better options for you.

Kidney problems. Tell your doctor if you have any kidney problems before treatment with Diastat. Having kidney problems may increase the risk of certain side effects from this medication. Your doctor can help determine whether Diastat may be safe for you. In some cases, they may recommend a different medication for your condition.

Substance misuse. Diastat is a controlled substance. A controlled substance is a drug the government regulates due to the risks of dependence or misuse. Dependence can occur when your body needs a drug to function as it typically would. This condition is possible even if you take a drug exactly as prescribed. However, dependence can also lead to misuse. This is taking a drug in a way other than how a doctor prescribes it.

If you have a history of substance use disorder, tell your doctor before they prescribe Diastat. They may monitor your condition for symptoms of dependence or misuse during treatment. In some cases, they may recommend a different treatment option for you.

Older adults. Adults ages 65 years and older may have a higher risk of side effects from Diastat. If you’re an older adult, talk with your doctor before they prescribe Diastat. They may recommend more frequent monitoring for side effects during treatment with this drug.

Alcohol with Diastat

Your doctor will likely recommend avoiding alcohol if you’re receiving Diastat. This is because alcohol can cause similar side effects to the drug. For example, both alcohol and Diastat can cause dizziness, headache, and reduced muscle coordination. Drinking alcohol during treatment can increase your risk of side effects. In some cases, these side effects can be serious or even life threatening.

It’s important to note that Diastat is only prescribed to treat a seizure that’s already happening. So, you won’t receive Diastat every day. Because of this, your doctor may only recommend avoiding alcohol when you receive a dose of the drug. When you don’t receive the drug, it may be safe for you to drink alcohol.

If you have questions about drinking alcohol during treatment, talk with your doctor or pharmacist.

Pregnancy and breastfeeding while receiving Diastat

Below is important information about receiving Diastat during pregnancy and while breastfeeding.

Pregnancy

In many cases, your doctor may recommend that you do not receive Diastat during pregnancy.

Receiving Diastat late in pregnancy may cause side effects or withdrawal symptoms in a newborn. Withdrawal symptoms are side effects that can occur when you stop taking a drug that your body has become dependent on.

A newborn exposed to this drug may experience side effects, including sleepiness or difficulty breathing. Additionally, withdrawal symptoms may include irritability, tremors, or inconsolable crying. If you need to receive Diastat during pregnancy, be sure to tell your doctor. They will recommend monitoring your child for side effects and withdrawal symptoms.

In addition, animal studies show that diazepam may increase the risk of congenital anomalies (also known as birth defects). Diazepam is the active drug in Diastat and Diastat AcuDial. However, animal studies don’t always predict what may happen in humans.

If you receive Diastat during pregnancy, you may want to register for the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of a pregnancy registry is to find out what effects a drug may have during pregnancy. You can register by calling 888-233-2334 or by visiting the website.

If you’re pregnant or planning to become pregnant, talk with your doctor before Diastat treatment. They can help determine the best treatment option for you.

Breastfeeding

In many cases, your doctor may also recommend avoiding Diastat while breastfeeding.

Diastat is present in breast milk. So, a child who’s breastfed by someone receiving the drug will likely be exposed to it. In this case, the child may experience side effects, including sleepiness or poor feeding.

If you’re breastfeeding or planning to breastfeed, talk with your doctor before treatment with Diastat. They can help determine the best treatment option for you.

Diastat is a Schedule IV controlled substance. A controlled substance is a drug the government regulates due to the risks of dependence or misuse. Due to this, it has boxed warnings for the risks of misuse, addiction, withdrawal, and dependence. Boxed warnings are the most serious warnings recommended by the Food and Drug Administration (FDA). The purpose of a boxed warning is to alert patients and prescribers about the risks of a medication.

Risk of misuse and addiction

It’s possible for Diastat to cause increased risks of misuse and addiction. Misuse is taking a drug in a way other than how a doctor prescribes it. Addiction refers to feeling unable to stop taking a drug, even though it may be causing harm.

In some cases, misuse or addiction can be serious or even life threatening. The risk of life threatening side effects may increase if you receive the drug while taking other substances. These other substances may include certain other medications or alcohol.

If you have a history of substance use disorder, be sure to tell your doctor before they prescribe Diastat. You may have a higher risk of misuse and addiction if you have a history of substance use disorder. Your doctor may recommend more frequent monitoring during your treatment with this drug. In some cases, they may recommend a different treatment option for you.

Risk of withdrawal and dependence

Diastat may increase your risks of withdrawal and dependence. With dependence, your body needs the drug to feel as it typically would. Dependence can lead to misuse, which can be serious or even life threatening.

Withdrawal can occur when you stop taking a drug that your body is dependent on. Withdrawal can cause symptoms, which may be serious. Symptoms of withdrawal can include:

To help prevent withdrawal and dependence, your doctor will likely recommend limiting how often you receive Diastat.

Additionally, if you receive Diastat often, they may recommend slowly decreasing your dose over time. This allows your body to adjust to a lower amount of medication. In turn, this may decrease the risk of withdrawal symptoms.

If you have concerns about withdrawal and dependence while receiving Diastat, tell your doctor.

In most cases, side effects of Diastat are mild. However, serious side effects are also possible from receiving this medication.

If you’d like to learn more about Diastat, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from receiving the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.