Note: This document contains side effect information about deflazacort. Some dosage forms listed on this page may not apply to the brand name Emflaza.
Summary
Common side effects of Emflaza include: cushingoid appearance, weight gain, constipation, and increased appetite. Other side effects include: abnormal behavior, back pain, and fever. Continue reading for a comprehensive list of adverse effects.
Applies to deflazacort: oral suspension, oral tablet.
Serious side effects of Emflaza
Along with its needed effects, deflazacort (the active ingredient contained in Emflaza) 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 Emflaza
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]
Respiratory
DMD:
-Very common (10% or more): Upper respiratory tract infection (up to 12%), cough (up to 12%)
-Common (1% to 10%): Nasopharyngitis, rhinorrhea, epistaxis, influenza, pharyngitis, hypoventilation[Ref]
