Pulmicort Nebuamp

In the U.S.

• Pulmicort
• Pulmicort Flexhaler
• Pulmicort Respules
• Pulmicort Turbuhaler

In Canada

• Pulmicort Nebuamp
• Rhinocort Turbuhaler

Available Dosage Forms:

• Suspension
• Powder
• Solution
• Aerosol Powder
• Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Budesonide is used to help prevent the symptoms of asthma. When used regularly every day, inhaled budesonide decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Budesonide is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe. Inhaled budesonide may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Respules® in children 12 months to 8 years of age. However, safety and efficacy have not been established in children younger than 12 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Pulmicort Flexhaler™ in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving inhaled budesonide.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bemiparin
• Boceprevir
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Clonixin
• Cobicistat
• Conivaptan
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Idelalisib
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pixantrone
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Telaprevir
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin
• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute—Should not be used in patients with this condition.

• Bone problems (e.g., osteoporosis) or
• Cataracts or
• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox, including recent exposure or
• Measles or
• Herpes simplex virus infection of the eye or
• Infections (virus, bacteria, or fungus) or
• Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.

• Milk protein allergy, severe—Use with caution. The Pulmicort Flexhaler™ contains lactose (milk sugar with milk protein), which may cause side effects for patients with this condition.

This section provides information on the proper use of a number of products that contain budesonide. It may not be specific to Pulmicort Nebuamp. Please read with care.

Inhaled budesonide is used to prevent asthma attacks. It is not used to stop an attack that has already started. For relief of an asthma attack that has already started, you or your child should use another medicine. If you do not have another medicine to use for an acute asthma attack or if you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor. This medicine usually begins to work in about 24 to 48 hours, but up to 2 to 6 weeks may pass before you feel the full effects.

Do not change your dose or stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

When using the Pulmicort Flexhaler™:

• This medicine comes as a powder that you breathe into the lungs with a special inhaler that is placed in the mouth. It is used by adults, teenagers, and children who are 6 years of age and older.
• The medicine comes with patient instructions. Read the instructions carefully before using this medicine. If you or your child do not understand the instructions or are not sure how to use the inhaler, check with your doctor.
• When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Before using this medicine, test or prime it.
• Hold the inhaler so that the white cover points up, then twist the cover and lift it off. Hold the inhaler upright (mouthpiece up) using the brown grip, then twist the middle of the inhaler fully in one direction as far as it will go, and then back again in the other direction. You will hear a click. Repeat this process one more time.
• You do not have to prime it again after this, even if you have not used it for a long time.
• After the inhaler is primed, twist the cover and lift it off.
• To load a dose, hold the inhaler in the upright position, then twist the grip fully in one direction as far as it will go, and then fully back again in the other direction. You will hear a click.
• Turn your head away from the inhaler and breathe out. Do not shake the inhaler.
• Place the mouthpiece between your lips and breathe in deeply and forcefully. You may not taste or feel the medicine.
• Do not chew or bite on the mouthpiece.
• Remove the inhaler from your mouth and breathe out. Do not blow or breathe into the inhaler.
• Repeat these steps if more than one dose is needed.
• When you are finished, place the cover back on the inhaler and twist shut. Rinse your mouth with water and spit out the water. Do not swallow the water. This helps prevent hoarseness, throat irritation, and infections in the mouth.
• Do not use the inhaler if it has been damaged or if the mouthpiece has become detached.
• Do not use a spacer with the Pulmicort Flexhaler™.
• Keep the inhaler clean and dry at all times. Follow the patient directions for cleaning and storing the inhaler.
• The inhaler has a dose indicator that keeps track of how many times you can use the inhaler before you need to open a new one. Check the dose indicator just below the mouthpiece. The dose indicator usually starts with either the number 60 or 120 when full.
• Discard the whole device when all doses have been used. The inhaler is empty when the number zero appears in the middle of the dose indicator window. You will be given a new inhaler each time you refill your prescription.

When using the Pulmicort Respules® liquid:

• This medicine comes as a liquid that you breathe into the lungs with a special breathing machine called a jet nebulizer. The nebulizer has a face mask or mouthpiece. It is used by children who are 12 months to 8 years of age.
• Your doctor will tell you which type of nebulizer to use with this medicine and will show you how to use the nebulizer. The medicine and nebulizer come with patient instructions. Read the instructions carefully before using the medicine or the machine. If you or your child do not understand the instructions or are not sure how to use the nebulizer, check with your doctor.
• Use this medicine at the same time each day, unless your child's doctor tells you otherwise.
• Do not mix this liquid with other medicines.
• Open the sealed aluminum foil envelope containing the medicine. Remove one container from the strip of five plastic containers with sealed caps. Write the current date on the back of the envelope when you open the foil pouch.
• Each container has one dose of medicine.
• Place the unused containers back in the foil pouch. This will protect the medicine from light.
• Shake the container in a circular motion before using it.
• Hold the container upright and open it by twisting off the cap.
• Slowly squeeze out all of the contents of the container into the nebulizer cup. Throw the empty container away.
• If your child is using a face mask, make sure that the mask fits tightly on the face to avoid getting the medicine in the eyes.
• Turn on the compressor to begin nebulizing the medication. The nebulizer turns the medicine into a fine mist that the child breathes into the lungs using the mouthpiece or mask.
• After the dose is completed, wash your child's face to prevent skin irritation.
• Rinsing your child's mouth with water after each dose may help prevent hoarseness, throat irritation, and infections in the mouth. Do not allow your child to swallow the water after rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For preventing an asthma attack:
  • For inhalation dosage form (powder inhaler):
    • Adults and children 6 years of age and older—At first, one or two puffs two times a day. Your doctor may increase your dose as needed.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For inhalation dosage form (suspension in a nebulizer):
    • Children 12 months to 8 years of age—0.5 to 1 milligram (mg) in a nebulizer once a day, or divided and given twice a day. Each container of liquid has one dose and a new container is used for each dose.
    • Infants younger than 12 months of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Pulmicort Flexhaler™ in a dry place at room temperature with the cover tightly in place.

Store the unused Pulmicort Respules® in an upright position at room temperature. Keep the medicine containers in the foil pouch until you are ready to use them. Do not freeze the containers. Once you have opened a foil pouch, the containers will only be good for 2 weeks. Throw away any unused containers if it has been longer than 2 weeks since you opened the pouch.

It is very important that your doctor check you or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects caused by this medicine.

You or your child should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor if you have any questions about this.

If your or your child's symptoms do not improve within one to two weeks, or if they become worse, check with your doctor.

This medicine may weaken your immune system. Avoid being around people who are sick or who have infections such as chickenpox or measles. Tell your doctor right away if you think you or your child have been exposed to chickenpox or measles.

If you or your child develop a skin rash, hives, or any type of allergic reaction (including anaphylaxis) to this medicine, stop using the medicine and check with your doctor as soon as possible.

This medicine may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you or your child have any signs of a throat infection.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.

This medicine may cause children to grow more slowly than normal. This would cause a child to not gain weight or get taller. Talk with your child's doctor if you think this is a problem or if you have any concerns.

This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Make sure any doctor or dentist knows that you or your child are using this medicine. You might need to stop using this medicine several days before having surgery.

Your doctor may want you or your child to carry a medical identification card that says this medicine is being used. You or your child may need additional medicine during an emergency, a severe asthma attack, an illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine 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:

• 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

• 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

Some side effects 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:

• Back pain

• 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Applies to budesonide: oral capsule delayed release, oral capsule extended release, oral tablet extended release

Other dosage forms:

• inhalation aerosol liquid, inhalation aerosol powder, inhalation powder, inhalation solution, inhalation suspension
• rectal foam, rectal kit

Along with its needed effects, budesonide (the active ingredient contained in Pulmicort Nebuamp) 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:

• Bruising easily
• chills
• colds
• cough or hoarseness
• fever
• flu-like symptoms
• sneezing
• sore throat

• Abdominal or stomach pain
• bladder pain
• bleeding after defecation
• bloody or cloudy urine
• blurred vision
• burning while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• convulsions
• cough producing mucus
• decreased urine
• diarrhea
• difficult or labored breathing
• difficult or painful urination
• dizziness
• dry mouth
• eye pain
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• general feeling of discomfort or illness
• headache
• heartburn
• increase in body movements
• increased thirst
• increased urge to urinate during the night
• irregular heartbeat
• joint pain
• loss of appetite
• lower back or side pain
• mood changes
• muscle aches and pains
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the chest, upper stomach, or throat
• pounding in the ears
• rectal bleeding
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• severe constipation
• shakiness in the legs, arms, hands, or feet
• shivering
• slow or fast heartbeat
• stomach cramps
• sweating
• swelling of the legs and feet
• swelling or puffiness of the face
• tightness in the chest
• trouble sleeping
• uncomfortable swelling around the anus
• unusual tiredness or weakness
• upper abdominal or stomach pain
• waking to urinate at night
• weight gain
• weight loss

• Bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• difficulty with swallowing
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

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:

• Acid or sour stomach
• belching
• blemishes on the skin
• heartburn
• indigestion
• pain or tenderness around the eyes and cheekbones
• pimples
• rounded or moon face
• stomach discomfort, upset, or pain
• stuffy nose

• Accumulation of pus
• agitation
• blistering, crusting, irritation, itching, or reddening of the skin
• bloated or full feeling
• change in hearing
• changes in vision
• cracked, dry, or scaly skin
• cracks in the skin at the corners of mouth
• difficulty having a bowel movement (stool)
• difficulty with moving
• dizziness or lightheadedness
• ear drainage
• earache or pain in the ear
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• increased appetite
• increased hair growth, especially on the face
• lack or loss of strength
• loss of memory
• muscle pains or stiffness
• nervousness
• pain, swelling, or redness in the joints
• passing gas
• pinpoint red or purple spots on the skin
• pressure in the stomach
• problems with memory
• redness, swelling, or soreness of the tongue
• sensation of spinning
• skin rash
• skin rash, encrusted, scaly, and oozing
• sleepiness or unusual drowsiness
• soreness or redness around the fingernails and toenails
• swelling of the abdominal or stomach area
• swollen joints
• uterine bleeding between menstrual periods

Applies to budesonide: compounding powder, inhalation powder, inhalation suspension, oral capsule extended release, oral delayed release capsule, 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

Epidemiological studies have shown an increased incidence of pneumonia in patients with chronic obstructive pulmonary disease (COPD) treated with inhaled corticosteroids.[Ref]

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

Deaths due to adrenal insufficiency have been reported in asthmatic patients during and after transferring from systemic corticosteroids to less systemically available inhaled corticosteroids.[Ref]

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[Ref]

Gastrointestinal

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

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, cramps, myalgia, growth suppression[Ref]

Long-term studies in clinical practice suggest that children treated with inhaled drug generally achieve adult height. However, in a long-term study in which inhaled drug dose was not titrated to the lowest effective dose, children were found to be 1.2 cm shorter as adults than those randomized to placebo.[Ref]

Cardiovascular

Common (1% to 10%): Fluid retention, palpitation
Uncommon (0.1% to 1%): Hypertension
Frequency not reported: Tachycardia, chest pain, dependent edema, 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

Common (1% to 10%): Acne, 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]

Some side effects of Pulmicort Nebuamp may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.