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Emflaza

Generic Name: deflazacort (de FLAZ a kort)
Brand Name: Emflaza
Physician reviewed Emflaza patient information - includes Emflaza description, dosage and directions.
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Drug Information:
Emflaza is a steroid that is used to treat Duchenne muscular dystrophy in adults and children at least 2 years old. Emflaza is not a cure for muscular dystrophy, but Emflaza may improve muscle strength and slow the progression of disability. Emflaza may also be used for purposes not listed in this medication guide. Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. You should not use Emflaza if you are allergic to it. Learn more

Emflaza Side Effects

Emflaza Side Effects

Note: This document contains side effect information about deflazacort. Some of the dosage forms listed on this page may not apply to the brand name Emflaza.

In 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. 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 (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
  • 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

  • Acid or sour stomach
  • 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

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

Hypersensitivity

Postmarketing reports: Anaphylaxis

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

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

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

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.

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

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

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

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

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

Genitourinary

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

Immunologic

Common (1% to 10%): Influenza, viral infection

Frequency not reported: Candidiasis

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

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)

Other

Common (1% to 10%): Pyrexia, otitis externa, heat exhaustion

Uncommon (0.1% to 1%): Vertigo

Postmarketing reports: Impaired healing

Oncologic

Corticosteroids:

Frequency not reported: Kaposi's Sarcoma, pheochromocytoma crisis

Hematologic

Postmarketing reports: Leukocytosis

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Emflaza