Deflazacort Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 20, 2023.

Applies to deflazacort: oral suspension, oral tablet.

Serious side effects of Deflazacort

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 or wasting
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

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
stomach pain
sudden loss of coordination
sudden, severe weakness or numbness in the arm or leg
tearing
thoughts of killing oneself
unexplained weight loss
vision changes
vomiting of material that looks like coffee grounds, severe and continuing

Other side effects of Deflazacort

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

Flushing or redness of the skin
increase appetite
stomach discomfort
unusually warm skin

Less common

Belching
blemishes on the skin
hair loss or thinning of the hair
pimples
stomach upset or pain
watering of the eyes

For Healthcare Professionals

Applies to deflazacort: oral suspension, oral tablet.

General

When used for the treatment of Duchenne muscular dystrophy (DMD): The most common adverse reactions were Cushingoid appearance, hirsutism, weight increased, central obesity, increased appetite, upper respiratory tract infection, cough, pollakiuria, and nasopharyngitis.

The adverse reactions listed under "Postmarketing reports" have been reported during post-approval use of this drug worldwide or during post-approval use of other corticosteroids.

When used for conditions needing treatment with glucocorticoids (Other Conditions): The incidence of predictable side effects (including hypothalamic-pituitary-adrenal [HPA] suppression) correlated with the relative potency of the drug, dosage, administration timing, and duration of therapy.^[Ref]

Cardiovascular

DMD:

-Common (1% to 10%): Irregular heart rate, hot flush

-Postmarketing reports: Heart failure, thromboembolism (particularly in patients with underlying conditions associated with increased thrombotic tendency)

Other Conditions:

-Frequency not reported: Heart failure, hypertrophic cardiomyopathy (in preterm infants), thromboembolism (particularly in patients with underlying conditions associated with increased thrombotic tendency)^[Ref]

Dermatologic

DMD:

-Very common (10% or more): Hirsutism (up to 35%), erythema (up to 28%)

-Common (1% to 10%): Rash, contusion, skin striae, acne, impetigo, alopecia, dermatitis acneiform

-Postmarketing reports: Toxic epidermal necrolysis

Other Conditions:

-Uncommon (0.1% to 1%): Hirsutism, striae, acne

-Rare (0.01% to 0.1%): Bruising

-Frequency not reported: Skin atrophy, telangiectasia^[Ref]

Endocrine

DMD:

-Very common (10% or more): Cushingoid appearance (up to 60%)

Other Conditions:

-Uncommon (0.1% to 1%): Suppression of the HPA axis, Cushingoid facies

-Frequency not reported: Steroid withdrawal syndrome (includes symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss)^[Ref]

Gastrointestinal

DMD:

-Very common (10% or more): Abdominal pain/upper abdominal pain (up to 18% combined)

-Common (1% to 10%): Constipation, abdominal discomfort, nausea, dyspepsia, gastrointestinal disorder, tooth abscess

-Postmarketing reports: Acute pancreatitis, hemorrhage, peptic ulceration, perforation of peptic ulcer

Other Conditions:

-Uncommon (0.1% to 1%): Dyspepsia, peptic ulceration, hemorrhage, nausea

-Frequency not reported: Perforation of peptic ulcer, acute pancreatitis^[Ref]

Genitourinary

DMD:

-Very common (10% or more): Pollakiuria (up to 15%)

-Common (1% to 10%): Urinary tract infection, glycose urine present, chromaturia, dysuria, hypertonic bladder, testicular pain

Other Conditions:

-Uncommon (0.1% to 1%): Amenorrhea

-Frequency not reported: Menstrual irregularity^[Ref]

Hematologic

DMD:

-Postmarketing reports: Leukocytosis

Other Conditions:

-Frequency not reported: Leukocytosis^[Ref]

Hypersensitivity

DMD:

-Rare (0.01% to 0.1%): Anaphylaxis

-Postmarketing reports: Hypersensitivity (including anaphylaxis)

Other Conditions:

-Frequency not reported: Hypersensitivity (including anaphylaxis)^[Ref]

Metabolic

DMD:

-Very common (10% or more): Central obesity (up to 25%), increased appetite (up to 14%)

-Postmarketing reports: Negative protein and calcium balance, potassium loss and hypokalemic alkalosis (with concomitant beta 2-agonist and xanthines), impaired carbohydrate tolerance with increased requirement for antidiabetic therapy

Other Conditions:

-Uncommon (0.1% to 1%): Sodium and water retention (with hypertension), impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, potassium loss and hypokalemic alkalosis (with concomitant beta 2-agonist and xanthines)

-Frequency not reported: Negative protein and calcium balance, increased appetite, tumor lysis syndrome (in patients with hematological malignancies)^[Ref]

Musculoskeletal

DMD:

-Common (1% to 10%): Back pain, fibula fracture, greenstick fracture, muscle spasms, myalgia, neck mass, neck pain, extremity pain

-Frequency not reported: Muscle weakness, tendon disorder, osteopenia

-Postmarketing reports: Avascular osteonecrosis, muscle wasting, negative nitrogen balance, tendonitis/tendon rupture (with concomitant quinolones), vertebral/long bone fractures

Other Conditions:

-Uncommon (0.1% to 1%): Osteoporosis, vertebral/long bone fractures

-Rare (0.01% to 0.1%): Muscle wasting

-Frequency not reported: Growth suppression in pediatric patients, avascular osteonecrosis, tendonitis/tendon rupture (with concomitant quinolones), myopathy, negative nitrogen balance^[Ref]

Nervous system

DMD:

-Common (1% to 10%): Psychomotor hyperactivity, dizziness

-Frequency not reported: Headache

-Postmarketing reports: Aggravation of epilepsy, increased intracranial pressure with papilledema in children (pseudotumor cerebri; usually after treatment withdrawal), cognitive dysfunction (including confusion, amnesia), benign intracranial hypertension, vertigo

Other Conditions:

-Uncommon (0.1% to 1%): Headache, vertigo

-Rare (0.01% to 0.1%): Benign intracranial hypertension

-Frequency not reported: Increased intracranial pressure with papilledema in children (pseudotumor cerebri; usually after treatment withdrawal), aggravation of epilepsy, cognitive dysfunction (including confusion, amnesia)^[Ref]

Ocular

DMD:

-Common (1% to 10%): Lacrimation increased, hordeolum

-Postmarketing reports: Chorioretinopathy, corneal/scleral thinning

Other Conditions:

-Frequency not reported: Vision blurred, increased intraocular pressure, glaucoma, papilledema, posterior subcapsular cataracts, chorioretinopathy, corneal/scleral thinning, exacerbation of ophthalmic viral/fungal diseases^[Ref]

Oncologic

Other Systemic Corticosteroids:

-Frequency not reported: Kaposi's sarcoma, pheochromocytoma crisis^[Ref]

Other

DMD:

-Very common (10% or more): Increased weight (up to 28%)

-Common (1% to 10%): Pyrexia, thirst, otitis externa, viral infection, back injury, face injury, heat exhaustion

-Postmarketing reports: Impaired healing, edema

Other Conditions:

-Common (1% to 10%): Weight gain

-Uncommon (0.1% to 1%): Increased susceptibility and severity of infections with suppression of clinical symptoms/signs, opportunistic infections, recurrence of dormant tuberculosis, edema

-Frequency not reported: Candidiasis, impaired healing^[Ref]

Psychiatric

DMD:

-Common (1% to 10%): Irritability, abnormal behavior, affect lability, aggression, depression, emotional disorder, middle insomnia, mood altered, mood swings, sleep disorder

-Postmarketing reports: Anxiety, delusions, hallucinations, mania, suicidal thoughts

Other Conditions:

-Uncommon (0.1% to 1%): Depressed and labile mood, behavioral disturbances

-Frequency not reported: Restlessness, irritable, euphoric, suicidal thoughts, psychotic reactions (including mania, delusions, hallucinations, aggravation of schizophrenia), anxiety, sleep disturbances, psychological effects (upon corticosteroid withdrawal)^[Ref]