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

Budesonide Information

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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