Information on Apriso side effects

Apriso can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days or weeks. But 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 took Apriso in clinical trials:

• headache*
• diarrhea*
• pain in the upper abdomen
• nausea
• common cold

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

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

Mild side effects that have been reported with Apriso include:

• pain in the upper abdomen
• nausea
• common cold
• hair loss*
• headache*
• diarrhea*

These side effects may be temporary, lasting a few days or weeks. But 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 and reviews side effects of the medication. If you develop a side effect while taking Apriso and want to tell the FDA about it, visit MedWatch.

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

Apriso may cause serious side effects. However, most serious side effects from Apriso are rare.

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

If you develop serious side effects while taking Apriso, 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:

• Kidney problems, including kidney stones. Symptoms can include:
  • decreased urination
  • nausea or vomiting
  • fatigue (lack of energy)
• Liver problems. Symptoms can include:
  • yellowing of the eyes or skin
  • belly pain
  • nausea or vomiting
• Mesalamine-induced acute intolerance syndrome.*
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Symptoms can include:
  • skin rash that may blister or peel
  • body aches
  • cough
  • fever
• Allergic reaction.*

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

Apriso may cause several side effects. Here are answers to some frequently asked questions about the drug’s side effects.

Do Apriso’s side effects include weight gain?

No, you shouldn’t have weight gain from taking Apriso. Weight gain wasn’t reported in clinical trials of Apriso.

However, it’s possible that you may gain weight if Apriso is working for you and keeping your symptoms of ulcerative colitis (UC) in remission. (During remission, you don’t have symptoms of UC.)

With active UC, you have symptoms of UC and you may not be able to eat or absorb nutrients from food like usual. If you reach remission with Apriso, you may be able to eat more food, which can cause you to gain weight.

It’s also possible to gain weight from other ulcerative colitis treatments, such as steroid medications, including prednisone. These drugs may be taken to decrease UC symptoms during a flare and may cause you to gain weight.

If you’re gaining weight while taking Apriso, talk with your doctor. They may be able to help you figure out what’s causing your weight gain.

Can Apriso cause long-term side effects?

It’s possible that Apriso may cause long-term side effects. However, most side effects that people experience with Apriso are mild and aren’t long term.

Some examples of long-term side effects that may occur include kidney or liver problems.

During your treatment with Apriso, your doctor will monitor you for symptoms of side effects. If you develop side effects, be sure to tell your doctor. If you develop any serious or possibly long-term side effects, your doctor may recommend a different medication for you.

Are there any side effects of stopping Apriso?

Not really. However, your UC symptoms may come back if you stop taking Apriso. This is because Apriso works to keep your UC in remission. If you stop taking the medication, UC symptoms may return.

Some possible symptoms of UC include:

• diarrhea
• abdominal pain or cramps
• rectal bleeding
• fatigue (lack of energy)

If you need to stop taking Apriso, talk with your doctor about other UC treatment options. Your doctor may recommend that you take a different medication. Or they may recommend ways to decrease your UC symptoms from returning once you stop Apriso.

Learn more about some of the side effects that Apriso may cause.

Headache

You may experience headaches while you’re taking Apriso. Headaches were the most common side effect reported in clinical trials of this medication.

What you can do

If you’re having headaches while taking Apriso, talk with your doctor.

Your doctor may recommend ways to decrease how often you get headaches. In some cases, they may recommend over-the-counter pain relievers, such as acetaminophen (Tylenol).

Be sure to tell your doctor if your headaches are severe or if they’re happening often. In this case, your doctor may recommend a medication other than Apriso for you.

Hair loss

Although rare, it’s possible to have hair loss while you’re taking Apriso. Hair loss was reported as a side effect in some people taking this medication in clinical trials.

Keep in mind that nutrient deficiencies are another possible cause of hair loss. Some people with ulcerative colitis (UC), which Apriso is used to treat, have trouble absorbing nutrients from the foods they eat. And certain vitamins and minerals are essential for healthy skin and hair.

What you can do

If you’re having hair loss with Apriso, talk with your doctor. They may recommend other ways to reduce your hair loss.

Consider talking with your doctor about checking for nutrient deficiencies. Your doctor may suggest ways to manage nutrient deficiencies that can help reduce your hair loss.

Mesalamine-induced acute intolerance syndrome

Some people have developed a rare side effect called mesalamine-induced acute intolerance syndrome. This is a serious side effect that can occur when you take mesalamine (the active drug in Apriso) or sulfasalazine (a drug that’s changed into mesalamine once inside the body).

It’s not known how often mesalamine-induced acute intolerance syndrome happens with Apriso use.

This syndrome caused symptoms that were very similar to an ulcerative colitis (UC) flare. And keep in mind that Apriso is used to treat UC.

Symptoms of this syndrome may include:

• stomach cramps or abdominal pain
• bloody diarrhea
• fever
• headache
• rash

What you can do

If you develop symptoms of mesalamine-induced acute intolerance syndrome, tell your doctor. They’ll help you figure out what’s causing your symptoms.

If you have this syndrome, your doctor will likely recommend that you stop taking Apriso.

Diarrhea

You may have diarrhea while you’re taking Apriso. Diarrhea was one of the most common side effects in people taking Apriso during clinical trials.

Keep in mind, diarrhea is also a common symptom of ulcerative colitis (UC), which Apriso is used to treat.

But, if you have bloody diarrhea, it could be a sign of mesalamine-induced acute intolerance syndrome. See the section just above for information about this syndrome.

What you can do

If you have diarrhea with Apriso, talk with your doctor.

Sometimes, diarrhea may be a symptom of UC. Other times, diarrhea may be a side effect of Apriso. Your doctor can help you determine what’s causing your diarrhea. And they can recommend the best way to treat it.

Allergic reaction

As with most drugs, Apriso can cause an allergic reaction in some people.

Symptoms of allergic reaction can be mild or serious and can include:

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

In some cases, allergic reactions to Apriso may be very serious and cause inflammation in your:

• heart
• kidneys
• liver
• lungs

If you’ve ever had an allergic reaction to salicylate drugs, such as aspirin, you should not take Apriso. This is because Apriso is related to salicylate drugs.

What you can do

If you have mild symptoms of allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms, and they’ll tell you whether you should keep taking Apriso.

But if you have serious symptoms of allergic reaction and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Be sure to talk with your doctor about your health history before you take Apriso. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:

Liver problems. Apriso can increase your risk of liver failure if you have liver disease. Your doctor may recommend monitoring your liver more often than usual while you take this drug. Or they may recommend a different medication to treat your condition.

Kidney problems. If you have any kidney problems, tell your doctor before you start taking Apriso. This medication can cause kidney problems, including kidney stones. If you already have kidney problems, taking Apriso can worsen them. Your doctor may monitor your kidneys more often than usual while you take Apriso. Or they may recommend a different medication for you, especially if your kidney problems get worse.

Allergic reaction. You should not take Apriso if you’ve ever had an allergic reaction to Apriso or any of its ingredients. Apriso is related to drugs called salicylates, such as aspirin. Be sure to tell your doctor if you have any allergies, including to salicylates. Your doctor can determine if Apriso is safe for you. Talk with your doctor about which other treatments are better choices for you.

Certain skin conditions. If you have certain skin conditions, such as eczema, you may have an increased risk for sunburn with Apriso. In some cases, sunburn can be severe. Your doctor will likely recommend that you avoid sun exposure. They may also suggest that you wear clothing that protects your skin and apply sunscreen when you’re outdoors.

Phenylketonuria. If you have phenylketonuria, you should tell your doctor before taking Apriso. (Phenylketonuria is a genetic condition that causes a protein called phenylalanine to build up in your body.) Apriso contains phenylalanine. If you are getting phenylalanine from other sources too, it may build up in your body. This can cause serious side effects, including seizures. Your doctor may monitor you more often than usual. Or they may recommend a different medication for you if you have phenylketonuria.

Heart problems. If you have any heart conditions, tell your doctor before you start Apriso. Rarely, Apriso can cause myocarditis (swelling of your heart) or pericarditis (swelling of the lining of your heart). If you have heart problems, Apriso can make your condition worse. Your doctor may monitor your heart health while you’re taking Apriso, or they may recommend a different medication for you.

Ages 65 years or older. It’s possible that Apriso may affect older adults, ages 65 years or older, differently than it does younger adults. Apriso may increase the risk of blood disorders in older adults. Some examples of these blood disorders include neutropenia (low level of neutrophils, a type of white blood cell) and agranulocytosis (very low level of neutrophils). Because of this risk, your doctor may monitor your blood often while you’re taking Apriso.

Alcohol with Apriso

Apriso isn’t known to interact with alcohol. But alcohol and Apriso can cause very similar effects. For example, both alcohol and Apriso can cause:

• headache
• nausea
• liver problems

Drinking alcohol while you’re taking Apriso can increase your risk of these side effects.

If you drink alcohol, talk with your doctor about whether there’s a safe amount of alcohol you can drink while you’re taking Apriso.

Pregnancy and breastfeeding while taking Apriso

Read below to find information about Apriso and pregnancy and breastfeeding.

Apriso and pregnancy

It’s not known if Apriso is safe to take during pregnancy.

In animal studies, Apriso didn’t appear to harm fetuses when given to pregnant animals. However, animal studies don’t always indicate what may happen in humans.

Additionally, having ulcerative colitis (UC) that’s not treated can cause harm to a fetus. Keep in mind that Apriso is used to treat UC.

If you’re pregnant or planning to become pregnant, talk with your doctor before taking Apriso.

Apriso and breastfeeding

It’s not known if it’s safe to take Apriso while breastfeeding. However, the drug does pass into human breast milk. So a child who is breastfed would be exposed to it.

It is possible that the drug could cause diarrhea in the breastfed child. But it’s not known what other effects the drug could have.

If you’re breastfeeding, talk with your doctor before starting Apriso.

You may have side effects with Apriso. In most cases, these side effects are mild. However, in rare cases, some people may experience serious side effects.

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

Besides talking with your doctor, you may wish to do some research on your own about this drug. You might find these articles helpful:

• More information on Apriso. For details on other aspects of Apriso, refer to this article.
• Dosage. For information about the dosage of Apriso, view this article.
• Drug comparison. To learn how Apriso compares with Lialda, read this article. Or to learn how Apriso compares with sulfasalazine, see this article.
• A look at ulcerative colitis. For details on ulcerative colitis, you can refer to our inflammatory bowel disease hub, and see our list of related articles.

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.