Formoterol Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 15, 2024.

Applies to formoterol: inhalation capsule, inhalation solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana™), budesonide/formoterol (Symbicort®), indacaterol (Arcapta® Neohaler®), salmeterol (Serevent®), or salmeterol/fluticasone (Advair®).

This medicine should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including formoterol. Ask your doctor if you have any questions.

Talk to your doctor or get medical care right away if:

• Your or your child's symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (eg, you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
• You have a significant decrease in your peak flow when measured as directed by your doctor.

You or your child may also be using an anti-inflammatory medicine, such as a steroid, together with this medicine. Do not stop using the anti-inflammatory medicine even if your asthma seems better, unless you are told to do so by your doctor.

Although this medicine decreases the number of asthma episodes, this medicine may also increase the chances of a severe asthma episode when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

Perforomist® may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Perforomist® may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: convulsions (seizures), decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, shortness of breath, or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

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.

Serious side effects of formoterol

Along with its needed effects, formoterol 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:

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
• diarrhea
• general feeling or discomfort or illness
• increased hunger
• increased urination
• loss of consciousness
• 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
• slow heartbeat
• stopping of the heart
• sudden loss of consciousness
• trouble sleeping
• vomiting

Other side effects of formoterol

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:

For healthcare professionals

Applies to formoterol: inhalation capsule, inhalation solution.

General adverse events

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

• 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]

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]

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

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

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

Renal

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

Hematologic

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

See also:

Frequently asked questions

• Can asthma inhalers cause a sore throat?

Further information

Formoterol side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer