Ortikos Side Effects

Generic name: budesonide

Medically reviewed by Drugs.com. Last updated on Jun 10, 2024.

Note: This document provides detailed information about Ortikos Side Effects associated with budesonide. Some dosage forms listed on this page may not apply specifically 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]

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]

Immunologic

• Common (1% to 10%): Oral candidiasis
• Frequency not reported: Immunosuppression, abscess, bronchospasm in patients with severe milk protein hypersensitivity^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 13%); abdominal pain (21%)
• Common (1% to 10%): Viral gastroenteritis, gastrointestinal mucosal candidiasis, 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

• Very common (10% or more): Muscle spasms (12%)
• 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, myalgia, growth suppression^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (12%), peripheral edema (17%)
• Common (1% to 10%): Fluid retention, palpitation

Uncommon (0.1% to 1%):

• Frequency not reported: Tachycardia, chest pain, 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

• Very common (10% or more): Acne (11%)
• Common (1% to 10%): 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]

Further information

Ortikos side effects can vary depending on the individual. 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.

Medical Disclaimer