Budez CR (Entocort / Budesonide) 3mg – 50 tablet

Budesonide Information

Pronunciation

byoo DES oh nide

What is this drug used for?

• It is used to treat Crohn disease and ulcerative colitis.

• It may be given to you for other reasons. Talk with the doctor.

Frequently reported side effects of this drug

• Common cold symptoms

• Heartburn

• Nausea

• Vomiting

• Diarrhea

• Passing gas

• Joint pain

• Back pain

• Abdominal pain

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit

• Skin changes like acne, stretch marks, slow healing, or hair growth

• Bleeding like vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding

• Infection

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss

• Moon face

• Buffalo hump

• Severe loss of strength and energy

• Irritability

• Tremors

• Fast heartbeat

• Confusion

• Sweating a lot

• Dizziness

• Passing out

• Swelling of the ankles

• Severe headache

• Bone pain

• Vision changes

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Product Availability

Ortikos (budesonide extended-release capsules): FDA approval June 2019; anticipated availability is currently unknown. Consult the prescribing information for additional information.

Storage and Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

Adverse Reactions

Cardiovascular: Chest pain, edema, facial edema, flushing, hypertension, palpitations, tachycardia

Central nervous system: Agitation, amnesia, confusion, dizziness, drowsiness, fatigue, headache, insomnia, malaise, nervousness, paresthesia, sleep disorder, vertigo

Dermatologic: Acne vulgaris, alopecia, dermatitis, dermatological disease, diaphoresis, eczema

Endocrine & metabolic: Adrenocortical insufficiency (more common in foam), bruise, decreased cortisol (more common in foam), hirsutism, hypokalemia, intermenstrual bleeding, menstrual disease, moon face, redistribution of body fat, weight gain

Gastrointestinal: Abdominal distention, anal disease, constipation, diarrhea, dyspepsia, enteritis, epigastric pain, exacerbation of Crohn’s disease, flatulence, gastrointestinal fistula, glossitis, hemorrhoids, increased appetite, intestinal obstruction, nausea, oral candidiasis, upper abdominal pain

Genitourinary: Dysuria, hematuria, nocturia, pyuria, urinary frequency, urinary tract infection

Hematologic & oncologic: Abnormal neutrophils, anemia, C-reactive protein increased, increased erythrocyte sedimentation rate, leukocytosis, purpura

Hepatic: Increased serum alkaline phosphatase

Hypersensitivity: Tongue edema

Infection: Abscess, viral infection

Neuromuscular & skeletal: Ankle edema, arthralgia, arthritis, hyperkinesia, muscle cramps, myalgia, tremor, weakness

Ophthalmic: Eye disease, visual disturbance

Otic: Otic infection

Respiratory: Bronchitis, dyspnea, flu-like symptoms, pharyngeal disease, respiratory tract infection, rhinitis, sinusitis

Miscellaneous: Fever

Rare but important or life-threatening: Allergic dermatitis, anaphylaxis, emotional lability, hyperglycemia, maculopapular rash, pancreatitis, peripheral edema, pruritus, pseudotumor cerebri, rectal bleeding –