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Foradil Aerolizer Side Effects

Generic Name: formoterol

Note: This page contains information about the side effects of formoterol. Some of the dosage forms included on this document may not apply to the brand name Foradil Aerolizer.

For the Consumer

Applies to formoterol: inhalation aerosol powder, inhalation capsule, inhalation solution

In addition to its needed effects, some unwanted effects may be caused by formoterol (the active ingredient contained in Foradil Aerolizer). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking formoterol:

More common:
  • Body aches or pain
  • chills
  • cold or flu-like symptoms
  • cough or hoarseness
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Less common:
  • Chest pain or discomfort
  • cough-producing mucous
  • dry throat
  • labored breathing
  • pain or tenderness around the eyes and cheekbones
  • shortness of breath
  • tender, swollen glands in the neck
  • tightness in the chest
  • trauma
  • trouble with swallowing
  • voice changes
Rare
  • Convulsions
  • decreased urine
  • dry mouth
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • increased thirst
  • loss of appetite
  • noisy breathing
Incidence not known:
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • hives
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • sweating

If any of the following symptoms of overdose occur while taking formoterol, get emergency help immediately:

Symptoms of overdose:
  • Arm, back, or jaw pain
  • chest tightness or heaviness
  • general feeling or discomfort or illness
  • increased hunger
  • increased urination
  • muscle pain
  • muscle spasm or jerking of all extremities
  • nausea
  • no blood pressure or pulse
  • numbness or tingling in the hands, feet, or lips
  • palpitations or pounding in the ears
  • pounding or racing heartbeat or pulse
  • sleeplessness
  • slow heartbeat
  • stopping of heart
  • sudden loss of consciousness
  • unconsciousness
  • vomiting

Minor Side Effects

Some of the side effects that can occur with formoterol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:
  • Agitation
  • back pain
  • increased mucous in the throat and lungs
  • leg cramps
  • muscle cramps
  • redness of the skin
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • trembling or shaking of the hands or feet
  • trouble sleeping

For Healthcare Professionals

Applies to formoterol: inhalation capsule, inhalation solution

General

Common adverse reaction to Long-acting beta2-adrenergic agonists (LABA) drugs include: Angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis, and insomnia.[Ref]

Other

Very common (10% or more): Viral infection (17.2%)
Common (1% to 10%): Fever (2.2%), fatigue
Very rare (less than 0.01%): Peripheral edema[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (7.4%)
Common (1% to 10%): Serious asthma exacerbations (up to 6.4%), bronchitis (4.6%), pharyngitis (3.5%), chest infection (2.7%), sinusitis (2.7%), dyspnea (2.1%), increased sputum (1.5%) tonsillitis (1.2%), dysphonia (1%), chest pain, cough
Uncommon (0.1% to 1%): Bronchospasm, throat irritation (including paradoxical bronchospasm)[Ref]

Serious asthma exacerbations (acute worsening of asthma resulting in hospitalization) occurred more commonly in patients receiving higher than the recommended dose of this drug than in patients who received placebo.
While most of cases of asthma exacerbation have been in patients with severe or acutely deteriorating asthma, a few have occurred in patients with less severe asthma. It is not possible to determine from these individual case reports whether this drug contributed to the events.[Ref]

Dermatologic

Common (1% to 10%): Rash (1.1%)
Uncommon (0.1% to 1%): Hyperhidrosis[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea (4.9%), vomiting (2.4%), dry mouth, nausea[Ref]

Musculoskeletal

Common (1% to 10%): Back pain (4.2%), leg cramps (1.7%), muscle cramps
Uncommon (0.1% to 1%): Myalgia[Ref]

Nervous system

Central nervous system stimulating effects have been sporadically reported following inhalation of beta2-sympathomimetics, manifesting as hyperexcitability. These effects were mainly observed in children up to 12 years of age.[Ref]

Common (1% to 10%): Headache, tremor, dizziness
Uncommon (0.1% to 1%): Taste disturbances, nervousness
Very rare (less than 0.01%): Central nervous system stimulation[Ref]

Psychiatric

Common (1% to 10%): Anxiety (1.5%). insomnia (1.5%)
Uncommon (0.1% to 1%): Sleep disturbances
Rare (less than 0.1%): Agitation, restlessness
Very rare (less than 0.01%): Abnormal behavior, hallucination[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia, palpitations, cardiac arrhythmias (e.g. atrial fibrillation), supraventricular tachycardia, extrasystoles, angina pectoris
Very rare (less than 0.01%): Prolongation of QTc interval, variations in blood pressure
Postmarketing reports: Tachyarrhythmia, blood pressure increased (including hypertension)[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (e.g. bronchospasm, exanthema, urticaria, pruritus)
Very rare (less than 0.01%): Angioneurotic edema, edema (including conjunctival irritation and eyelid edema)
Postmarketing reports: Anaphylactic reactions, including severe hypotension and angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema).[Ref]

Metabolic

Treatment with beta2-agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.[Ref]

Uncommon (0.1% to 1%): Hypokalemia, hyperglycemia[Ref]

Renal

Rare (less than 0.1%): Nephritis[Ref]

Hematologic

Very rare (less than 0.01%): Thrombopenia[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

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

3. "Product Information. Foradil (formoterol)" Novartis Pharmaceuticals, East Hanover, NJ.

4. "Product Information. Perforomist (formoterol)." Dey Laboratories, Napa, CA.

Not all side effects for Foradil Aerolizer may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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