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Entocort EC Side Effects

Generic Name: budesonide

Note: This page contains information about the side effects of budesonide. Some of the dosage forms included on this document may not apply to the brand name Entocort EC.

In Summary

Common side effects of Entocort EC include: acne vulgaris, moon face, and bruise. Other side effects include: hirsutism, and ankle edema. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to budesonide: oral capsule delayed release, oral capsule extended release, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by budesonide (the active ingredient contained in Entocort EC). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking budesonide:

More common:
  • Bruising easily
  • chills
  • colds
  • cough or hoarseness
  • fever
  • flu-like symptoms
  • sneezing
  • sore throat
Less common:
  • Abdominal or stomach pain
  • bladder pain
  • bleeding after defecation
  • bloody or cloudy urine
  • blurred vision
  • burning while urinating
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • convulsions
  • cough producing mucus
  • decreased urine
  • diarrhea
  • difficult or labored breathing
  • difficult or painful urination
  • dizziness
  • dry mouth
  • eye pain
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth
  • general feeling of discomfort or illness
  • headache
  • heartburn
  • increase in body movements
  • increased thirst
  • increased urge to urinate during the night
  • irregular heartbeat
  • joint pain
  • loss of appetite
  • lower back or side pain
  • mood changes
  • muscle aches and pains
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pain or discomfort in the chest, upper stomach, or throat
  • pounding in the ears
  • rectal bleeding
  • redness of the face, neck, arms, and occasionally, upper chest
  • runny nose
  • severe constipation
  • shakiness in the legs, arms, hands, or feet
  • shivering
  • slow or fast heartbeat
  • stomach cramps
  • sweating
  • swelling of the legs and feet
  • swelling or puffiness of the face
  • tightness in the chest
  • trouble sleeping
  • uncomfortable swelling around the anus
  • unusual tiredness or weakness
  • upper abdominal or stomach pain
  • waking to urinate at night
  • weight gain
  • weight loss
Incidence not known:
  • Bulging soft spot on the head of an infant
  • change in the ability to see colors, especially blue or yellow
  • difficulty with swallowing
  • hives
  • itching
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash

Minor Side Effects

Some of the side effects that can occur with budesonide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Acid or sour stomach
  • belching
  • blemishes on the skin
  • heartburn
  • indigestion
  • pain or tenderness around the eyes and cheekbones
  • pimples
  • rounded or moon face
  • stomach discomfort, upset, or pain
  • stuffy nose
Less common:
  • Accumulation of pus
  • agitation
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloated or full feeling
  • change in hearing
  • changes in vision
  • cracked, dry, or scaly skin
  • cracks in the skin at the corners of mouth
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • dizziness or lightheadedness
  • ear drainage
  • earache or pain in the ear
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • hair loss or thinning of the hair
  • increased appetite
  • increased hair growth, especially on the face
  • lack or loss of strength
  • loss of memory
  • muscle pains or stiffness
  • nervousness
  • pain, swelling, or redness in the joints
  • passing gas
  • pinpoint red or purple spots on the skin
  • pressure in the stomach
  • problems with memory
  • redness, swelling, or soreness of the tongue
  • sensation of spinning
  • skin rash
  • skin rash, encrusted, scaly, and oozing
  • sleepiness or unusual drowsiness
  • sleeplessness
  • soreness or redness around the fingernails and toenails
  • swelling of the abdominal or stomach area
  • swollen joints
  • unable to sleep
  • uterine bleeding between menstrual periods

For Healthcare Professionals

Applies to budesonide: compounding powder, inhalation powder, inhalation suspension, oral capsule extended release, oral tablet extended release, rectal foam

General

The most commonly reported adverse events with inhaled use have included nasopharyngitis, nasal congestion pharyngitis, rhinitis, and oral candidiasis. Headache, nausea, abdominal pain, and fatigue have been commonly reported with oral and rectal use. Due to the nature of its administration (inhalation, gastro-protective oral formulations, and rectal enema), it is less likely to cause systemic adverse effects associated with the use of corticosteroids.[Ref]

Respiratory

Epidemiological studies have shown an increased incidence of pneumonia in patients with chronic obstructive pulmonary disease (COPD) treated with inhaled corticosteroids.[Ref]

Very common (10% or more): Respiratory infection (up to 13%)
Common (1% to 10%): Nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, epistaxis, cough, dysphonia, hoarseness
Frequency not reported: Bronchitis, dyspnea, pharynx disorder, pneumonia
Postmarketing reports: Throat irritation, sinusitis[Ref]

Endocrine

Deaths due to adrenal insufficiency have been reported in asthmatic patients during and after transferring from systemic corticosteroids to less systemically available inhaled corticosteroids.[Ref]

Common (1% to 10%): Decreased blood cortisol, moon face
Uncommon (0.1% to 1%): Hirsutism, Cushingoid syndrome
Frequency not reported: Intermenstrual bleeding, menstrual disorder, HPA axis suppression, deaths due to adrenal insufficiency
Postmarketing reports: Hypocorticism[Ref]

Immunologic

Common (1% to 10%): Oral candidiasis
Frequency not reported: Immunosuppression, abscess[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 13%); abdominal pain (21%)
Common (1% to 10%): Viral gastroenteritis, upper abdominal pain, flatulence, abdominal distension, constipation, dyspepsia, vomiting, diarrhea, sore/irritated throat, dry mouth, bad taste, rectal disorder, rectal hemorrhage, ulcerative colitis, burning in the rectum or pain
Frequency not reported: Anus disorder, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder
Postmarketing reports: Pancreatitis[Ref]

Nervous system

Very common (10% or more): Headache (up to 28%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Disturbance of smell
Very rare (less than 0.01%): Pseudotumor cerebri (including papilledema)
Frequency not reported: Hyperkinesia, paresthesia, tremor, somnolence
Postmarketing reports: Benign intracranial hypertension[Ref]

Psychiatric

Common (1% to 10%): Mood changes, sleep changes, insomnia,
Frequency not reported: Amnesia
Postmarketing reports: Psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, anxiety, mood swings[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, bronchospasm
Postmarketing reports: Cough, wheezing, bronchospasm[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain
Very rare (less than 0.01%): Osteoporosis, aseptic necrosis of bone (femur and head of the humerus)
Frequency not reported: Bone mineral density reductions, arthritis, cramps, myalgia, growth suppression[Ref]

Long-term studies in clinical practice suggest that children treated with inhaled drug generally achieve adult height. However, in a long-term study in which inhaled drug dose was not titrated to the lowest effective dose, children were found to be 1.2 cm shorter as adults than those randomized to placebo.[Ref]

Cardiovascular

Common (1% to 10%): Fluid retention, palpitation
Uncommon (0.1% to 1%): Hypertension
Frequency not reported: Tachycardia, chest pain, dependent edema, flushing[Ref]

Metabolic

Frequency not reported: Weight gain, increased appetite, hypokalemia[Ref]

Hematologic

Common (1% to 10%): Leukocytosis
Uncommon (0.1% to 1%): Anemia
Rare (0.01% to 0.1%): Eosinophilic conditions, Churg-Strauss[Ref]

Ocular

Common (1% to 10%): Conjunctivitis
Frequency not reported: Eye abnormality, abnormal vision
Postmarketing reports: Glaucoma, cataracts, increased intraocular pressure[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, moniliasis
Frequency not reported: Dysuria, micturition frequency, nocturia[Ref]

Dermatologic

Common (1% to 10%): Acne, rash, contact dermatitis, eczema, pustular rash, pruritus, purpura
Very rare (less than 0.01%): Allergic exanthema, red striae, petechiae, ecchymosis, delayed wound healing
Frequency not reported: Face edema, alopecia, dermatitis, eczema, skin disorder, increased sweating, purpura
Postmarketing reports: Skin bruising[Ref]

Hepatic

Uncommon (0.1% to 1%): Increase in liver enzymes[Ref]

Other

Common (1% to 10%): Otitis media, fatigue, earache
Frequency not reported: Asthenia, malaise, fever, flu-like disorder, vertigo[Ref]

References

1. "Product Information. Pulmicort Flexhaler (budesonide)." A-S Medication Solutions, Chicago, IL.

2. "Product Information. Pulmicort Respules (budesonide)." Astra-Zeneca Pharmaceuticals, Wayne, PA.

3. "Product Information. Entocort (budesonide)." AstraZeneca Pharma Inc, Mississauga, ON.

4. "Product Information. Entocort EC (budesonide)." Perrigo, L. Company, Allegan, MI.

5. "Product Information. Uceris (budesonide)." Santarus Inc, San Diego, CA.

Not all side effects for Entocort EC may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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