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Foradil Aerolizer Side Effects

Generic Name: formoterol

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

For the Consumer

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

Along with its needed effects, formoterol (the active ingredient contained in Foradil Aerolizer) 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 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
  • 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

Get emergency help immediately if any of the following symptoms of overdose occur while taking formoterol:

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

Some side effects of formoterol 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:

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


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]


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]


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]


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


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


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]


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]


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]


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]


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]


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


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


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.

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

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. 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.