Creon: Dosage, side effects, alternatives, cost, uses, and more - Medical News Today

Creon can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Creon. These lists do not include all possible side effects.

For more information about the possible side effects of Creon, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you've had with Creon, you can do so through MedWatch.

Mild side effects

Mild side effects* of Creon can include:

• abnormal stools, such as having stools with a strange color, consistency, form, or smell
• dizziness
• frequent bowel movements
• gas
• high or low blood sugar levels
• sore throat, cough, or other cold symptoms
• abdominal (belly) pain
• vomiting

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don't go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Creon. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Creon's Medication Guide.

Serious side effects

Serious side effects from Creon aren't common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you're having a medical emergency.

Serious side effects and their symptoms can include:

• Mouth irritation. Symptoms can include:
  • sores or ulcers in your mouth or on your tongue
  • burning or stinging in your mouth
• High uric acid level in the blood. Symptoms can include:
  • swollen or painful joints
  • swelling, pain, or redness in your big toe
• Viral infection.*
• Fibrosing colonopathy (scarring or narrowing in your colon).*
• Allergic reaction.*

* For more information about this side effect, see the "Side effect details" section below.

Side effects in children

One 2010 clinical trial looked at the safety of using Creon in children ages 7 to 11 years. In this study, side effects were seen in:

• 29.4% of children taking Creon
• 56.3% of children taking a placebo (treatment with no active drug)

None of the children quit the study due to side effects. And none of the side effects reported in the children were serious.

Another study checked the short-term safety of Creon in infants and children with exocrine pancreatic insufficiency (EPI)* caused by cystic fibrosis. Their ages ranged from 4 months to 6 years. In this study, during Creon treatment:

• 0% of the infants and children had serious side effects
• 6% of the infants and children had:
  • irritability
  • lowered appetite

* For more information about EPI and its possible causes, see the "Creon uses" section below.

Side effect details

You may wonder how often certain side effects occur with this drug.Below is some detail on certain side effects this drug may cause. The side effects described below were seen in clinical studies involving both adults and children taking Creon.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Creon.

Call your doctor right away if you have an allergic reaction to Creon, as the reaction could become severe. But call 911 or your local emergency number if your symptoms feel life threatening or if you think you're having a medical emergency.

Mild allergic reactions

Allergic reactions weren't reported during clinical trials of Creon. But some symptoms of mild allergic reaction, such as rash and itching, have been reported since Creon was released onto the market.

However, because these side effects weren't seen during clinical studies, it's hard to know how often they occur. It's also difficult to know if Creon actually causes them. For more information about possible skin side effects with Creon, see the "Skin conditions" section below.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth, swelling, or redness in your skin)

Severe allergic reactions

A more severe allergic reaction is rare but possible.

For example, pancrelipase, which Creon contains, comes from the pancreas of pigs. So if you have an allergy to pork, you may be allergic to pancrelipase medications, including Creon. Severe allergies with other products made with pig pancrelipase have occurred.

Severe allergies, including pork allergies, weren't reported during clinical trials of Creon. But possible symptoms of severe allergies, such as certain skin problems, have been reported since Creon was released onto the market.

However, because these side effects weren't seen during clinical studies, it's hard to know how often they occur. It's also difficult to know if Creon actually causes them. (For more information about possible skin side effects with Creon, see the "Skin conditions" section below.)

Symptoms of a severe allergic reaction can include:

• anaphylaxis (severe, life threatening allergy), which may cause:
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing
• asthma (trouble breathing, chest tightness, cough, or wheezing)
• hives
• severe itching

Tell your doctor if you have a pork allergy before starting Creon. They can help you weigh the risks and benefits of using this medication.

Viral infections

Pancrelipase medications, such as Creon, are made using the pancreas of pigs. So it's possible that by taking pancrelipase you may become infected with a virus found in pigs. But this type of infection hasn't been reported in anyone taking Creon.

General symptoms of viral infections can include:

• fever
• fatigue (lack of energy)
• body aches
• malaise (generally not feeling well)

If you have symptoms of infection and you're concerned it's a viral infection from Creon, talk with your doctor. They can check to see if you have an infection. And they'll recommend how to treat your symptoms.

Fibrosing colonopathy

Creon could increase your risk for fibrosing colonopathy. This condition is rare, but it's also very serious. With fibrosing colonopathy, your colon becomes narrowed inside because of scarring or strictures.

Initial clinical trials of Creon didn't report fibrosing colonopathy in anyone taking the drug. But it has been reported with other pancreatic enzyme replacement products similar to Creon.

Fibrosing colonopathy is a serious condition. Call your doctor right away if you have any of its symptoms. These can include any new or worsening:

• bloating
• bloody diarrhea
• constipation
• nausea, vomiting, or diarrhea
• abdominal (belly) pain

You may be able to lower your risk for fibrosing colonopathy by sticking to your Creon treatment plan as prescribed by your doctor.

If you develop the condition, you may need surgery to treat it. Or your doctor may lower your Creon dosage to try and keep the condition from getting worse. It's unclear whether or not fibrosing colonopathy can be reversed once it's occurred.

Call your doctor right away if you have any of the symptoms listed above. But don't stop taking Creon or change your Creon dosage without first talking with your doctor.

Digestive problems, such as constipation

Digestive side effects have been seen with Creon. For example, two clinical trials studied Creon in people with exocrine pancreatic insufficiency (EPI)* due to cystic fibrosis. In these studies, vomiting occurred in:

• 6% of people taking Creon
• 2% of people taking placebo (treatment with no active drug)

Another study looked at using Creon for EPI due to either chronic pancreatitis† or pancreatectomy‡. In this study, the following digestive system problems were reported:

Diarrhea, nausea, and constipation have also been seen in people taking Creon. But these side effects weren't seen in initial clinical trials of the drug.

Instead, people reported having diarrhea, nausea, and constipation after Creon was released onto the market. Because these side effects weren't seen during clinical studies, it's unclear how often they've happened or if Creon actually causes them.

* For more information about EPI and its possible causes, see the "Creon uses" section below.
† With chronic pancreatitis, you have long-lasting inflammation in your pancreas.
‡ Pancreatectomy is a partial or full removal of the pancreas.

What to do for digestive problems

While you're taking Creon, keep track of any digestive problems you're having. Write down what you eat, your Creon doses, and any symptoms or side effects you're having. Then share this information with your doctor.

Digestive problems could be a side effect of Creon. But they could also be a sign that Creon therapy isn't helping your body properly break down food. For example, having oily, smelly, or bulky stools could mean that your body isn't absorbing fat from foods.

Digestive symptoms could also be caused by your diet or a health condition you may have. Or they could be due to the condition you're managing with Creon.

Keep in mind that certain digestive symptoms may indicate a more serious side effect of Creon called fibrosing colonopathy. (For more information about this, see the "Fibrosing colonopathy" section above.) These symptoms include gas, abdominal (belly) pain, and constipation.

So, don't ignore new or worsening digestive system symptoms. Instead, tell your doctor right away. And don't stop or change your Creon without your doctor's instruction.

Skin conditions

Some people using Creon have had various skin conditions. But these skin side effects weren't seen in initial clinical trials of Creon.

Instead, people reported having skin conditions after Creon was released onto the market. Because the side effects weren't seen during clinical studies, it's hard to know how often they've occurred or if Creon actually caused them.

Skin conditions reported by people using Creon include:

Call your doctor right away if you have a severe rash, itching, or hives while using Creon. In some cases, these symptoms could indicate a serious allergic reaction to the drug. (For more information about this, see the "Allergic reaction" section above.)

Also, tell your doctor if you have any mild skin issues that bother you or that don't go away.

Blurry vision

Blurred vision has been reported in some people using Creon. But this side effect wasn't seen in clinical trials of Creon.

Instead, people reported having blurred vision after Creon was released onto the market. Because this wasn't seen during clinical studies, it's hard to know how often it has occurred or if Creon actually caused it.

Keep in mind that blurry vision could also be a symptom of either high or low blood sugar levels. And either can happen in people with certain conditions that Creon is used to manage. In addition, having abnormal blood sugar levels is a possible side effect of Creon.

So don't ignore blurry vision that doesn't clear up. Instead, tell your doctor about any vision problems you have with Creon treatment. You doctor can check to see if you have any conditions that could affect your blood sugar level or cause blurry vision.

Muscle spasms or pain

Some people have had myalgia (muscle pain) and muscle spasms while taking Creon. But these side effects weren't seen in clinical trials of the drug. Instead, some people reported having myalgia and muscle spasms after Creon was released onto the market.

Because muscle pain or spasms weren't seen during clinical studies, it's hard to know how often they've occurred or if Creon actually caused them. For example, pain can be caused by chronic pancreatitis*. And Creon is used in people with chronic pancreatitis.

If you have new or worsening pain, especially abdominal (belly) or back pain, talk with your doctor. Don't self-treat the pain or change your Creon dosage without your doctor's instruction.

* With chronic pancreatitis, you have long-lasting inflammation in your pancreas.