Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Entocort Rectal (Budesonide-rectal). If you are concerned about side effects, discuss the risks and benefits of Entocort Rectal (Budesonide-rectal) with your doctor.

The following side effects have been reported by at least 1% of people taking Entocort Rectal (Budesonide-rectal). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Diarrhea
• indigestion
• itching
• nausea
• skin rash

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Entocort Rectal (Budesonide-rectal).

Each budesonide enema 0.02 mg/mL consists of 2 components: a dispersible tablet and an applicator bottle of vehicle solution.

Each dispersible tablet contains 2.3 mg of micronized budesonide. Nonmedicinal ingredients: colloidal silicon dioxide, lactose, lactose anhydrous, magnesium stearate, cross-linked polyvidone, and riboflavin-5-phosphate sodium.

The vehicle is a solution containing methylparaben, propylparaben, sodium chloride, and purified water.

Do not use Entocort Rectal (Budesonide-rectal) if you:

• are allergic to budesonide or any ingredients of the medication
• have complications in the area of the digestive tract where Entocort Rectal (Budesonide-rectal) is effective (e.g., bowel perforation, possibility of bowel obstruction, abscess or fistulae)
• have any active bacterial, fungal, or viral infections
• have active Tuberculosis infection

There may be an interaction between budesonide and any of the following:

• Abiraterone acetate
• Aldesleukin
• Amiodarone
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Bicalutamide
• boceprevir
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• conivaptan
• Crizotinib
• Cyclosporine
• Deferasirox
• Desipramine
• Dronedarone
• grapefruit juice
• Haloperidol
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hyaluronidase
• imatinib
• Lomitapide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Metronidazole
• nefazodone
• Norfloxacin
• Sertraline
• telaprevir
• Tetracycline

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Entocort Rectal (Budesonide-rectal). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Entocort Rectal (Budesonide-rectal).

General precautions: Advise all doctors involved in your care that you have been using Entocort Rectal (Budesonide-rectal). If you have been taking "cortisone" tablets, your doctor may want you to discontinue the tablet form of the medication. Much less corticosteroid is absorbed from budesonide enemas, so stopping the tablets should be done gradually to reduce the likelihood of withdrawal symptoms such as tiredness, headache, nausea, or vomiting.

Medical conditions: People with Diabetes, Glaucoma, liver disease, Osteoporosis, or stomach ulcers should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Entocort Rectal (Budesonide-rectal), and whether any special monitoring is needed.

Severe bowel disease: People with severe ulcerative disease of the bowel should use Entocort Rectal (Budesonide-rectal) with caution, as they are susceptible to perforation of the bowel wall. If you have severe ulcerative disease, discuss with your doctor how Entocort Rectal (Budesonide-rectal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entocort Rectal (Budesonide-rectal), and whether any special monitoring is needed.

Stopping medication: Stopping Entocort Rectal (Budesonide-rectal) suddenly may cause symptoms of the illness to return. Do not stop using Entocort Rectal (Budesonide-rectal) abruptly without checking with your doctor first.

Pregnancy: Entocort Rectal (Budesonide-rectal) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using Entocort Rectal (Budesonide-rectal), contact your doctor immediately.

Breastfeeding: Entocort Rectal (Budesonide-rectal) passes into breast milk. If you are a breast-feeding mother and are using budesonide enemas, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children:  The safety and effectiveness of budesonide enemas have not been established for children.