What the label lists and what reports show
Arformoterol side effects
Arformoterol's FDA label: “Most common adverse reactions (≥2% incidence and more common than placebo) are pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder.” FAERS holds 231 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (52 reports).
- Generic listed
Check it at the source: the arformoterol FDA label on DailyMed (effective April 14, 2026, Sun Pharmaceutical Industries, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of arformoterol tartrate inhalation solution?Arformoterol tartrate inhalation solution can cause serious side effects, including: people with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as arformoterol (the medicine in arformoterol tartrate inhalation solution), without also using a medicine called an inhaled corticosteroid have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breath, or death. Call your healthcare provider if breathing problems worsen over time while using arformoterol tartrate inhalation solution. You may need a different treatment. Get emergency medical care if: your breathing problems worsen quickly. you use a rescue inhaler medicine, but it does not relieve your breathing problems. COPD symptoms that get worse over time. […]
Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective April 14, 2026 (SPL set f1005878-0c48-4b9a-843e-b6cf6b8bb251), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥2% incidence and more common than placebo) are pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder.
From the label: adverse reactions, continuedLong-acting beta 2 -adrenergic agonists, such as arformoterol tartrate, as monotherapy (without inhaled corticosteroids) for asthma increase the risk of asthma-related events. Arformoterol tartrate inhalation solution is not indicated for the treatment of asthma [see Warnings and Precautions (5.1)]. Most common adverse reactions (≥2% incidence and more common than placebo) are pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder. (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Beta 2 -Agonist Adverse Reaction Profile Adverse reactions to arformoterol tartrate inhalation solution are expected to be similar in nature to other beta 2 -adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. 6.2 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective April 14, 2026 (SPL set f1005878-0c48-4b9a-843e-b6cf6b8bb251), via openFDA; the full label on DailyMed
What do FAERS reports show?
231 reports list arformoterol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 79 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Arformoterol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions