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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
• 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
• 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
• Fast heartbeat
• Sweating a lot
• 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.
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.
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
Rare but important or life-threatening: Allergic dermatitis, anaphylaxis, emotional lability, hyperglycemia, maculopapular rash, pancreatitis, peripheral edema, pruritus, pseudotumor cerebri, rectal bleeding