Xtampza ER side effects

This article describes possible side effects of Xtampza ER oral tablet. You can learn more about Xtampza ER by talking with your doctor.

Xtampza ER is a brand-name medication that comes as an oral tablet. It isn’t available in a generic version. This article describes possible side effects of Xtampza ER.

Xtampza ER oral tablet has several boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effects of Xtampza ER in detail” section below.

Need a diagnosis or prescription quickly? For certain health conditions, Optum Perks offers personalized on-demand care with no appointment required. For $25, answer a few questions online and receive a diagnosis and treatment plan from a board certified healthcare professional in 15 minutes or less. Get started here.

More common side effects of Xtampza ER

Xtampza ER oral tablet may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of Xtampza ER oral tablet include:

• nausea
• headache
• constipation*
• sleepiness
• vomiting

* To learn more about this side effect, see the “Side effects of Xtampza ER in detail” section below.

Mild side effects of Xtampza ER

Xtampza ER may cause certain mild side effects. Most often, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of Xtampza ER oral tablet that occurred in studies include:

• abdominal pain
• constipation*
• dizziness
• fatigue
• flushing
• headache
• itchiness
• nausea
• sleepiness
• vomiting

* To learn more about this side effect, see the “Side effects of Xtampza ER in detail” section below.

Xtampza ER oral tablet may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

Serious side effects of Xtampza ER

Xtampza ER may cause certain serious side effects. If you have any serious side effects from Xtampza ER oral tablet, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the FDA approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with Xtampza ER.

Serious side effects of Xtampza ER oral tablet that occurred in studies include:

• adrenal insufficiency
• impaired cognition affecting the ability to drive a vehicle, operate machinery, and other tasks requiring concentration and decision-making
• low blood pressure, including when standing up, which lead to fainting
• severe constipation
• withdrawal symptoms, if the participants suddenly stopped taking Xtampza ER
• opioid-induced hyperalgesia and allodynia*
• boxed warnings†:
  • risk of misuse and addiction
  • risk of life threatening respiratory depression
  • risks if used with benzodiazepines or certain other medications
  • risks with accidental ingestion
  • risk of neonatal opioid withdrawal syndrome (NOWS)

* To learn more about this side effect, see the “Side effects of Xtampza ER in detail” section below.
† Xtampza ER oral tablet has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of Xtampza ER in detail” section below.

Suicide prevention

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

• Call the 988 Suicide and Crisis Lifeline at 988.
• Text HOME to the Crisis Text Line at 741741.
• Not in the United States? Find a helpline in your country with Befrienders Worldwide.
• Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you are not in the same household, stay on the phone with them until help arrives.

Download the free Optum Perks Discount Card to save up to 80% on some prescription medications.

Allergic reaction

For some people, Xtampza ER oral tablet can cause an allergic reaction.

In general, symptoms of an allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction due to Xtampza ER oral tablet, your doctor may recommend taking a different medication instead.

Side effects of Xtampza ER in detail

Below you’ll find details on some of the side effects of Xtampza ER oral tablet.

Boxed warnings

Xtampza ER oral tablet has several boxed warnings. A boxed warning is the most serious warning from the FDA.

The following boxed warnings are discussed here:

• risk of misuse and addiction
• risk of life threatening respiratory depression
• risks if used with benzodiazepines or certain other medications
• risks with accidental ingestion

Risk of misuse and addiction

Xtampza ER is an opioid drug. Treatment with any opioid carries a risk of misuse and addiction. Misuse occurs when a drug is used in a way other than how it was prescribed. With addiction, you continue using a drug despite it causing harm. It’s important to note that you can be physically dependent on Xtampza ER without being addicted to it.

Misusing Xtampza ER can increase the risk of respiratory depression and a life threatening overdose. Xtampza ER is formulated in a manner that helps prevent misuse but doesn’t prevent it entirely.

Due to this risk, Xtampza ER has a risk evaluation and mitigation strategy (REMS) program. This is a safety program required by the FDA for specific drugs. It ensures that doctors, pharmacists, and patients are aware of the serious side effects a drug may cause. REMS programs also help make sure these drugs are used only when the potential benefits outweigh the risks.

If you have a substance use disorder, your doctor may choose to prescribe a pain treatment other than Xtampza ER.

Risk of life threatening respiratory depression

Like other opioids, Xtampza ER can cause respiratory depression. With respiratory depression, your breathing becomes slow and shallow. This effect can be life threatening in severe cases.

The risk of respiratory depression is higher when you first start treatment with Xtampza ER and any time your dosage is increased.

To lower this risk, your doctor will likely prescribe a low Xtampza ER dose to begin treatment. Then, they can slowly increase your dose over time as needed to treat your pain symptoms. Your doctor may also recommend that you and members of your household keep Narcan (naloxone) nasal spray with you while you’re taking Xtampza ER. Narcan can be used in an emergency to treat respiratory depression or other symptoms of an opioid overdose. Talk with your doctor or pharmacist to learn more about Narcan.

Note that if you or someone else needs to receive Narcan for a suspected overdose, you should still call 911 or immediately go to the closest emergency room. Narcan is only a temporary treatment for an overdose. Because Xtampza ER has long-lasting effects, an overdose must still be treated by healthcare professionals in a hospital or emergency room.

Risks if used with benzodiazepines or certain other medications

If you take benzodiazepines or certain other medications while taking Xtampza ER, you’re at higher risk of certain side effects.

Xtampza ER interacts with drugs that:

• Depress activity in your central nervous system (CNS): These medications are called CNS depressants. Examples include benzodiazepines such as alprazolam (Xanax) and certain sleep medications, such as zolpidem (Ambien).
• Drugs that decrease the activity of the CYP3A4 enzyme: This is a special protein your body makes that breaks down certain drugs, including Xtampza ER. Drugs that can block this enzyme are called CYP3A4 inhibitors. Taking a CYP3A4 inhibitor with Xtampza ER can increase the amount of Xtampza ER in your system. This raises your risk of side effects, including the risk of overdose. Examples of CYP3A4 inhibitors include ketoconazole and ritonavir (Norvir).
• Drugs that increase the activity of CYP3A4: These medications are called CYP3A4 inducers. If taken with Xtampza ER, these drugs can cause your body to break down Xtampza ER more quickly. This places you at higher risk of an overdose if you stop taking the CYP3A4 inducer during your treatment with Xtampza ER. Examples of CYP3A4 inducers include phenytoin (Dilantin) and carbamazepine (Tegretol, others).

Before you begin taking Xtampza ER, tell your doctor and pharmacist about all medications you take. This should include any over-the-counter medications and supplements you may take. They can determine if any interact with Xtampza ER. They may suggest stopping treatment with the other drug or exploring other treatments besides Xtampza ER.

Risks with accidental ingestion

Accidentally taking even one dose of Xtampza ER can cause an overdose, which may be life threatening. This risk is higher in children, as well as in people who have not taken an opioid.

If you’re prescribed Xtampza ER, keep your prescription stored in a safe, secure place where others cannot easily access it. And, talk with your doctor about keeping Narcan (naloxone) nasal spray with you while you’re taking Xtampza ER. Immediately call 911 or seek emergent medical attention if someone else in your home accidentally takes a dose of your Xtampza ER.

Ways to manage

If you have concerns about any of these risks, contact your doctor.

Opioid-induced hyperalgesia and allodynia

In studies, opioid-induced hyperalgesia and allodynia were rare in people using Xtampza ER oral tablet. This side effect may be serious.

With opioid-induced hyperalgesia and allodynia, you experience worsening pain or sensitivity to pain after taking an opioid. Symptoms include:

• increased pain when your opioid dose is increased
• decreased pain when your opioid dose is decreased
• pain due to stimuli that typically shouldn’t cause pain (allodynia)

Ways to manage

If you have concerns about opioid-induced hyperalgesia and allodynia, tell your doctor. They’ll likely recommend:

• decreasing your Xtampza ER dosage, or
• trying a different opioid to treat your pain symptoms

Constipation

In studies, constipation was somewhat common in people taking Xtampza ER oral tablet. This side effect is usually mild. Constipation was more common when first starting treatment in these studies, and became less common as treatment with Xtampza ER continued.

With constipation, you experience difficulty having a bowel movement. You may have hard, dry stool, and fewer than three bowel movements per week.

Certain factors can increase the risk of constipation with Xtampza ER oral tablet. These include using other medications that can cause or worsen constipation, such as amitriptyline or oxybutynin.

Ways to manage

If you experience symptoms of constipation, tell your doctor. They can discuss possible treatments for opioid-induced constipation (OIC) with you. Possible options include:

• over-the-counter laxatives, such as docusate (Colace) or bisacodyl (Dulcolax)
• prescription medications for OIC, such as naloxegol (Movantik) or methylnaltrexone (Relistor)
• home remedies, such as drinking plenty of fluids and consuming an adequate amount of fiber

Warnings for Xtampza ER

Below are some factors you may want to discuss with your doctor before taking Xtampza ER oral tablet.

Boxed warning

Xtampza ER oral tablet has several boxed warnings. A boxed warning is the most serious warning from the FDA.

For details, see the “Side effects of Xtampza ER in detail” section above. There are also boxed warnings related to using the drug during pregnancy, which are discussed below.

Other warnings

It may not be safe for you to take Xtampza ER oral tablet if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether Xtampza ER oral tablet is a safe treatment option for you.

Before taking Xtampza ER oral tablet, tell your doctor about your health and medications you take. Things to consider include:

• breathing or lung condition, such as chronic obstructive pulmonary disease (COPD) or sleep apnea
• blockage in your gastrointestinal (GI) tract, such as a paralytic ileus
• seizures
• brain tumor or head injury
• substance use disorder
• past allergic reaction to Xtampza ER

Xtampza ER and pregnancy

Xtampza ER oral tablet has a boxed warning for the risk of NOWS if used during pregnancy. A boxed warning is the most serious warning from the FDA.

Taking opioids, including Xtampza ER, during pregnancy can cause NOWS in the infant after delivery. NOWS can be life threatening if not recognized and treated quickly.

With NOWS, an infant becomes dependent on opioids. This means that their body needs the opioid to function as usual. An infant with NOWS may have withdrawal symptoms after they are born. These can include high-pitched crying, tremor, diarrhea, and problems gaining weight.

Because of this risk, your doctor may suggest other pain treatments during pregnancy. If you must take Xtampza ER during pregnancy, your doctor needs to be aware. This way, they can ensure your child receives proper treatment for NOWS after delivery.

Xtampza ER and breastfeeding

Xtampza ER oral tablet should not be taken while breastfeeding. The drug is known to appear in breast milk, which means it possibly could cause side effects in a breastfed child. If you’re currently breastfeeding or planning to do so, talk with your doctor before using this medication. Your doctor may recommend other ways to feed your child during treatment with Xtampza ER.

Xtampza ER and alcohol

Xtampza ER oral tablet is known to interact with alcohol. You should avoid consuming alcohol while you’re taking Xtampza ER. Drinking alcohol increases the risk of serious side effects of Xtampza ER. It can even increase the risk of a life threatening overdose.

If you drink alcohol, talk with your doctor about how to avoid it during your treatment with Xtampza ER oral tablet.

Disclaimer: Optum Perks 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.