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Deflazacort Side Effects

In Summary

Commonly reported side effects of deflazacort include: cushingoid appearance, weight gain, constipation, and increased appetite. Other side effects include: abnormal behavior, back pain, and fever. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to deflazacort: oral suspension, oral tablet

Along with its needed effects, deflazacort 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 deflazacort:

More common
  • Backache
  • blurred vision
  • body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • facial hair growth in females
  • fever
  • fractures
  • full or round face, neck, or trunk
  • headache
  • increased hair growth, especially on the face
  • increased thirst or urination
  • irritability
  • loss of sexual desire or ability
  • loss of voice
  • menstrual irregularities
  • muscle aches
  • muscle wasting
  • nasal congestion
  • sneezing
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
  • weight gain
Less common
  • Bladder pain
  • bloody or cloudy urine
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with moving
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • lower back or side pain
  • muscle pains or stiffness
  • nausea
  • shivering
  • sweating
  • swollen joints
  • trouble sleeping
  • vomiting
Rare
  • Difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or rash
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Incidence not known
  • Abdominal or stomach pain
  • blindness
  • blistering, peeling, loosening of the skin
  • changes in behavior
  • decreased vision
  • depression
  • dry mouth
  • eye pain
  • false or unusual sense of well-being
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • indigestion
  • loss of sexual desire or ability
  • muscular pain, tenderness, wasting, or weakness
  • pain in the bones
  • pain in the chest, groin, or legs, especially the calves
  • pounding in the ears
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • severe abdominal pain, cramping, or burning
  • severe, sudden headache
  • slow or fast heartbeat
  • slurred speech
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • tearing
  • thoughts of killing oneself
  • unexplained weight loss
  • vision changes
  • vomiting of material that looks like coffee grounds, severe and continuing

Some side effects of deflazacort 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
  • Abdominal or stomach discomfort
  • flushing or redness of the skin
  • increase appetite
  • unusually warm skin
Less common

For Healthcare Professionals

Applies to deflazacort: oral suspension, oral tablet

General

The most frequently reported adverse reactions have included Cushingoid appearance, hirsutism, weight gain, central obesity, increased appetite, pollakiuria, irritability, abnormal behavior, and pyrexia.[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis[Ref]

Dermatologic

Common (1% to 10%): Erythema, rash, contusion. skin striae, acne, impetigo, alopecia, dermatitis acneiform
Rare (0.01% to 0.1%): Bruising
Frequency not reported: Skin atrophy, telangiectasia
Postmarketing reports: Toxic epidermal necrolysis[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal discomfort, abdominal pain/abdominal pain upper, nausea, dyspepsia, gastrointestinal disorder, tooth abscess
Postmarketing reports: Acute pancreatitis, hemorrhage, peptic ulceration, perforation of peptic ulcer[Ref]

Endocrine

Very common (10% or more): Cushingoid appearance (up to 33%)
Common (1% to 10%): Hirsutism
Frequency not reported: Suppression of the hypothalamic-pituitary-adrenal axis, amenorrhea, menstrual irregularity, steroid withdrawal syndrome, acute adrenal insufficiency[Ref]

Corticosteroids produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression. Acute adrenal insufficiency can occur if corticosteroids are withdrawn abruptly. The risk of serious consequences of HPA axis suppression can be reduced by gradual dose reduction, however, in stress situations, reinstitution of steroid therapy may be necessary. Additionally, a steroid "withdrawal syndrome" which is seemingly unrelated to adrenocortical insufficiency may occur following abrupt discontinuance of steroids. The steroid withdrawal syndrome includes symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, and/or weight loss.[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, fibula fracture, greenstick fracture, muscle spasms, myalgia, neck mass, neck pain, extremity pain
Rare (0.01% to 0.1%): Muscle wasting
Frequency not reported: Muscle weakness, tendon disorder, osteopenia, growth suppression in pediatric patients, osteoporosis
Postmarketing reports: Avascular osteonecrosis, muscle wasting, negative nitrogen balance, tendonitis and tendon rupture (with concomitant quinolone administration) vertebral and long bone fractures[Ref]

Psychiatric

Common (1% to 10%): Irritability, abnormal behavior, affect lability, aggression, depression, emotional disorder, middle insomnia, mood altered, mood swings, sleep disorder
Postmarketing reports: Anxiety, amnesia, delusions, hallucinations, mania, suicidal thoughts[Ref]

Nervous system

Common (1% to 10%): Psychomotor hyperactivity, dizziness
Uncommon (0.1% to 1%): Headache
Postmarketing reports: Aggravation of epilepsy, increased intracranial pressure with papilledema in children (pseudotumor cerebri; usually after treatment withdrawal), cognitive dysfunction, benign intracranial hypertension, aggravation of epilepsy[Ref]

Cardiovascular

Common (1% to 10%): Irregular heart rate, hot flush
Frequency not reported: Sodium and water retention with hypertension
Postmarketing reports: Heart failure, edema, thromboembolism (particularly in patients with underlying conditions associated with increased thrombotic tendency[Ref]

Ocular

Common (1% to 10%): Lacrimation increased, hordeolum
Frequency not reported: Increased intraocular pressure, glaucoma, papilledema, posterior subcapsular cataracts, exacerbation of ophthalmic viral or fungal diseases
Postmarketing reports: Chorioretinopathy, corneal or scleral thinning[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, glycosuria, chromaturia, dysuria, hypertonic bladder, testicular pain[Ref]

Immunologic

Common (1% to 10%): Influenza, viral infection
Frequency not reported: Candidiasis[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (12%), cough (12%)
Common (1% to 10%): Nasopharyngitis, rhinorrhea, epistaxis, pharyngitis, hypoventilation
Frequency not reported: Recurrence of dormant tuberculosis[Ref]

Renal

Very common (10% or more): Pollakiuria (12%)

Metabolic

Very common (10% or more): Increased weight (20%), increased appetite (14%),
Common (1% to 10%): Central obesity, constipation, thirst
Postmarketing reports: Negative protein and calcium balance, potassium loss and hypokalemic alkalosis (with concomitant beta 2-agonist and xanthines)[Ref]

Other

Common (1% to 10%): Pyrexia, otitis externa, heat exhaustion
Uncommon (0.1% to 1%): Vertigo
Postmarketing reports: Impaired healing[Ref]

Oncologic

Corticosteroids:
Frequency not reported: Kaposi's Sarcoma, pheochromocytoma crisis[Ref]

Hematologic

Postmarketing reports: Leukocytosis[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Emflaza (deflazacort)." Marathon Pharmaceuticals, Deerfield, IL.

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.

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