Ortikos Side Effects
Generic name: budesonide
Medically reviewed by Drugs.com. Last updated on Nov 14, 2023.
Note: This document contains side effect information about budesonide. Some dosage forms listed on this page may not apply to the brand name Ortikos.
Applies to budesonide: inhalation powder, inhalation suspension. Other dosage forms:
- oral capsule delayed release, oral capsule extended release, oral tablet extended release
- rectal foam
Serious side effects of Ortikos
Along with its needed effects, budesonide (the active ingredient contained in Ortikos) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking budesonide:
More common
- Body aches or pain
- chills
- congestion
- cough
- diarrhea
- dryness or soreness of the throat
- fever
- general feeling of discomfort or illness
- headache
- hoarseness
- joint pain
- loss of appetite
- muscle aches and pains
- nausea
- pain or tenderness around the eyes and cheekbones
- shivering
- shortness of breath or troubled breathing
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- tender, swollen glands in the neck
- tightness of the chest or wheezing
- trouble with sleeping
- trouble with swallowing
- unusual tiredness or weakness
- voice changes
- vomiting
Less common
- Bruising
- darkening of the skin
- depression
- dizziness
- earache
- excessive muscle tone
- fainting
- fractures
- large, flat, blue, or purplish patches in the skin
- lower back or side pain
- muscle stiffness
- muscle tension or tightness
- painful or difficult urination
- redness or swelling in the ear
- skin rash
- sore mouth or tongue
- white patches in the mouth or on the tongue
Other side effects of Ortikos
Some side effects of budesonide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
Less common
- Acid or sour stomach
- belching
- change in taste or bad, unusual, or unpleasant (after) taste
- difficulty with breathing
- difficulty with moving
- dry mouth
- ear congestion
- headache, severe and throbbing
- heartburn
- indigestion
- muscle cramping
- neck pain
- sleeplessness
- stomach discomfort, upset, or pain
- swollen joints
- unable to sleep
- unexplained runny nose or sneezing
- weakness
For Healthcare Professionals
Applies to budesonide: compounding powder, inhalation powder, inhalation suspension, oral capsule extended release, oral delayed release capsule, oral suspension, 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
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]
Epidemiological studies have shown an increased incidence of pneumonia in patients with chronic obstructive pulmonary disease (COPD) treated with inhaled corticosteroids.[Ref]
Endocrine
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]
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]
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]
More about Ortikos (budesonide)
- Check interactions
- Compare alternatives
- Imprints, shape & color data
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: glucocorticoids
- Breastfeeding
- En español
Patient resources
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Related treatment guides
References
1. Product Information. Pulmicort Respules (budesonide). Astra-Zeneca Pharmaceuticals. 2001;PROD.
2. Product Information. Entocort (budesonide). AstraZeneca Pharma Inc. 2001.
3. Product Information. Uceris (budesonide). Santarus Inc. 2013.
4. Product Information. Pulmicort Flexhaler (budesonide). A-S Medication Solutions. 2016.
5. Product Information. Entocort EC (budesonide). Perrigo, L. Company. 2016.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.