Applies to formoterol: inhalation capsule, inhalation solution.

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:

More common

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• hoarseness
• loss of voice
• runny or stuffy 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
• tender, swollen glands in the neck
• tightness in the chest
• trauma
• trouble with swallowing
• voice changes

Rare

• Decreased urine
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• increased thirst
• loss of appetite
• noisy breathing
• seizures

Incidence not known

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• 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
• 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:

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

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

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]

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]

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

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]