Drug · FAERS side-effect profile with label screen
Formoterol Fumarate Dihydrate side effects: what 4,693 FDA adverse event reports show
Drug class
Long-acting beta 2 -adrenergic agonist (beta 2 -agonist)
FDA label, Indications wording of the closest related product
Label matched
Formoterol Fumarate Dihydrate (Formoterol Fumarate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,693 reports · 83% serious · 526 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Formoterol fumarate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: • Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
FDA label, Indications and Usage
What it is
Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 1Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 4Not in label — unassessed 29
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 364 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Obstructive airways disorder | 421 | 175.1 159.5–192.2ROR 192.2 · χ² 69,959 / p <1e-300 | 167.2 EB05 154.2 · IC025 +7.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 122.0 | no trial data cached |
| Full blood count abnormal | 318 | 138.9 124.7–154.7ROR 148.9 · χ² 42,094 / p <1e-300 | 133.6 EB05 121.7 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious PRR 124.6 | no trial data cached |
| Sputum discoloured | 200 | 96.5 84.2–110.7ROR 100.8 · χ² 18,419 / p <1e-300 | 93.7 EB05 83.3 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 85.7 | no trial data cached |
| Sleep disorder due to a general medical condition | 254 | 71.3 63.2–80.4ROR 75.3 · χ² 17,260 / p <1e-300 | 69.8 EB05 62.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 95.6 | no trial data cached |
| Emphysema | 146 | 65.4 55.6–76.8ROR 67.4 · χ² 9,058 / p <1e-300 | 63.9 EB05 55.7 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 50.4 | no trial data cached |
| Blood test abnormal | 198 | 63.9 55.7–73.3ROR 66.6 · χ² 12,026 / p <1e-300 | 62.6 EB05 55.6 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 67.2 · ♀ 98% (drug 59%) | no trial data cached |
| Vasculitis | 124 | 48.0 40.3–57.2ROR 49.3 · χ² 5,602 / p <1e-300 | 47.2 EB05 40.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 35.6 · ♀ 0% (drug 59%) | no trial data cached |
| Sleep apnoea syndrome | 203 | 47.9 41.8–54.8ROR 50.0 · χ² 9,184 / p <1e-300 | 47.2 EB05 42.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 39.1 · ♀ 92% (drug 59%) | no trial data cached |
| Asthma | 1,129 | 45.4 43.2–47.8ROR 59.5 · χ² 48,779 / p <1e-300 | 44.9 EB05 42.8 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 43.3 | no trial data cached |
| Wheezing | 591 | 45.1 41.8–48.6ROR 51.4 · χ² 25,232 / p <1e-300 | 44.6 EB05 41.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 42.0 | no trial data cached |
| Pulmonary mass | 142 | 43.1 36.6–50.7ROR 44.4 · χ² 5,739 / p <1e-300 | 42.4 EB05 36.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 31.9 | no trial data cached |
| Arteriosclerosis | 90 | 43.0 35.0–52.9ROR 43.9 · χ² 3,620 / p <1e-300 | 42.3 EB05 35.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 30.7 · ♀ 0% (drug 59%) | no trial data cached |
| Pulmonary fibrosis | 157 | 37.0 31.7–43.2ROR 38.2 · χ² 5,420 / p <1e-300 | 36.5 EB05 32.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 | no trial data cached |
| Haemoptysis | 206 | 33.1 29.0–37.9ROR 34.6 · χ² 6,352 / p <1e-300 | 32.8 EB05 29.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · ♀ 37% (drug 59%) | no trial data cached |
| Nodule | 96 | 33.1 27.1–40.4ROR 33.8 · χ² 2,935 / p <1e-300 | 32.7 EB05 27.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 35.4 · ♀ 6% (drug 59%) | no trial data cached |
| Hypothyroidism | 220 | 31.1 27.3–35.4ROR 32.5 · χ² 6,336 / p <1e-300 | 30.8 EB05 27.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.6 | no trial data cached |
| Carpal tunnel syndrome | 93 | 29.8 24.3–36.4ROR 30.4 · χ² 2,542 / p <1e-300 | 29.4 EB05 24.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 25.4 · ♀ 100% (drug 59%) | no trial data cached |
| Therapeutic product effect incomplete | 444 | 28.2 25.8–30.8ROR 31.1 · χ² 11,594 / p <1e-300 | 28.0 EB05 25.9 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 36.5 | no trial data cached |
| Aspiration | 67 | 27.8 21.9–35.3ROR 28.2 · χ² 1,694 / p <1e-300 | 27.4 EB05 22.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 19.8 · ♀ 95% (drug 59%) | no trial data cached |
| Productive cough (cough with phlegm) | 287 | 27.2 24.3–30.5ROR 28.9 · χ² 7,200 / p <1e-300 | 27.0 EB05 24.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 | no trial data cached |
| Iron deficiency anaemia | 50 | 24.4 18.5–32.2ROR 24.7 · χ² 1,095 / p 2e-240 | 24.1 EB05 19.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 · ♀ 100% (drug 59%) | no trial data cached |
| Loss of personal independence in daily activities | 249 | 23.5 20.8–26.5ROR 24.8 · χ² 5,326 / p <1e-300 | 23.3 EB05 21.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 21.4 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 390 | 21.8 19.8–24.0ROR 23.7 · χ² 7,720 / p <1e-300 | 21.7 EB05 20.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.9 · ♀ 86% (drug 59%) | no trial data cached |
| Hypoxia (low oxygen) | 169 | 21.6 18.6–25.1ROR 22.4 · χ² 3,293 / p <1e-300 | 21.5 EB05 18.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 | no trial data cached |
| Nephropathy | 41 | 19.6 14.4–26.6ROR 19.8 · χ² 702 / p 5e-155 | 19.3 EB05 14.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · ♀ 100% (drug 59%) | no trial data cached |
| Hiatus hernia | 56 | 19.4 14.9–25.1ROR 19.6 · χ² 953 / p 1e-209 | 19.2 EB05 15.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 · ♀ 96% (drug 59%) | no trial data cached |
| Chronic obstructive pulmonary disease | 211 | 18.1 15.9–20.7ROR 19.0 · χ² 3,396 / p <1e-300 | 18.0 EB05 16.1 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 13.6 | no trial data cached |
| Fibromyalgia | 95 | 17.5 14.4–21.4ROR 17.9 · χ² 1,461 / p <1e-300 | 17.4 EB05 14.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 · ♀ 100% (drug 59%) | no trial data cached |
| Lower respiratory tract infection | 173 | 17.1 14.8–19.8ROR 17.7 · χ² 2,604 / p <1e-300 | 17.0 EB05 15.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · ♀ 95% (drug 59%) | no trial data cached |
| Skin laceration | 39 | 16.2 11.8–22.1ROR 16.3 · χ² 539 / p 2e-119 | 15.9 EB05 12.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 · ♀ 95% (drug 59%) | no trial data cached |
| Sinus disorder | 70 | 15.8 12.5–20.0ROR 16.0 · χ² 954 / p 8e-210 | 15.7 EB05 12.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.0 · ♀ 96% (drug 59%) | no trial data cached |
| Blood iron decreased | 41 | 15.6 11.5–21.1ROR 15.7 · χ² 543 / p 2e-120 | 15.3 EB05 11.7 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 14.7 · ♀ 95% (drug 59%) · 90% clinician | no trial data cached |
| Pulmonary congestion | 46 | 15.6 11.7–20.8ROR 15.7 · χ² 611 / p 4e-135 | 15.4 EB05 11.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Candida infection (yeast infection) | 56 | 15.0 11.6–19.5ROR 15.2 · χ² 718 / p 2e-158 | 14.9 EB05 11.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · ♀ 96% (drug 59%) | no trial data cached |
| Respiratory tract infection | 84 | 14.5 11.7–17.9ROR 14.7 · χ² 1,039 / p 2e-228 | 14.4 EB05 11.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · ♀ 91% (drug 59%) | no trial data cached |
| Respiratory disorder | 97 | 14.5 11.9–17.6ROR 14.8 · χ² 1,202 / p 1e-263 | 14.4 EB05 12.1 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.2 | no trial data cached |
| Blood pressure systolic increased | 62 | 14.2 11.1–18.2ROR 14.4 · χ² 744 / p 3e-164 | 14.0 EB05 11.2 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 10.6 | no trial data cached |
| Abscess | 49 | 13.8 10.4–18.2ROR 13.9 · χ² 566 / p 2e-125 | 13.5 EB05 10.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · ♀ 98% (drug 59%) | no trial data cached |
| Body temperature decreased | 30 | 13.5 9.5–19.3ROR 13.6 · χ² 335 / p 4e-75 | 13.1 EB05 9.4 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 10.4 | no trial data cached |
| Osteopenia | 45 | 13.2 9.9–17.7ROR 13.3 · χ² 495 / p 7e-110 | 12.9 EB05 9.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · ♀ 11% (drug 59%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 1,311 | 10.4 9.9–10.9ROR 14.0 · χ² 11,377 / p <1e-300 | 10.3 EB05 9.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Asthma | 1,129 | 45.4 43.2–47.8ROR 59.5 · χ² 48,779 / p <1e-300 | 44.9 EB05 42.8 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 43.3 | no trial data cached |
| Cough | 713 | 11.4 10.7–12.2ROR 13.3 · χ² 6,834 / p <1e-300 | 11.4 EB05 10.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Wheezing | 591 | 45.1 41.8–48.6ROR 51.4 · χ² 25,232 / p <1e-300 | 44.6 EB05 41.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 42.0 | no trial data cached |
| Pneumonia (lung infection) | 530 | 7.3 6.8–7.9ROR 8.1 · χ² 2,933 / p <1e-300 | 7.3 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Therapeutic product effect incomplete | 444 | 28.2 25.8–30.8ROR 31.1 · χ² 11,594 / p <1e-300 | 28.0 EB05 25.9 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 36.5 | no trial data cached |
| Fatigue (tiredness) | 422 | 2.4 2.2–2.7ROR 2.6 · χ² 366 / p 7e-82 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Obstructive airways disorder | 421 | 175.1 159.5–192.2ROR 192.2 · χ² 69,959 / p <1e-300 | 167.2 EB05 154.2 · IC025 +7.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 122.0 | no trial data cached |
| Headache | 401 | 2.9 2.6–3.1ROR 3.0 · χ² 498 / p 1e-110 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · ♀ 86% (drug 59%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 390 | 21.8 19.8–24.0ROR 23.7 · χ² 7,720 / p <1e-300 | 21.7 EB05 20.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.9 · ♀ 86% (drug 59%) | no trial data cached |
| Hypertension (high blood pressure) | 321 | 6.8 6.1–7.5ROR 7.2 · χ² 1,587 / p <1e-300 | 6.7 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 · ♀ 85% (drug 59%) | no trial data cached |
| Full blood count abnormal | 318 | 138.9 124.7–154.7ROR 148.9 · χ² 42,094 / p <1e-300 | 133.6 EB05 121.7 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious PRR 124.6 | no trial data cached |
| Productive cough (cough with phlegm) | 287 | 27.2 24.3–30.5ROR 28.9 · χ² 7,200 / p <1e-300 | 27.0 EB05 24.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 | no trial data cached |
| Malaise (feeling unwell) | 256 | 2.6 2.3–2.9ROR 2.7 · χ² 256 / p 6e-58 | 2.6 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Sleep disorder due to a general medical condition | 254 | 71.3 63.2–80.4ROR 75.3 · χ² 17,260 / p <1e-300 | 69.8 EB05 62.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 95.6 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Sputum discoloured — n=200, PRR 96.5
- Sleep disorder due to a general medical condition — n=254, PRR 71.3
- Vasculitis — n=124, PRR 48.0
- Sleep apnoea syndrome — n=203, PRR 47.9
- Wheezing — n=591, PRR 45.1
- Pulmonary mass — n=142, PRR 43.1
- Arteriosclerosis — n=90, PRR 43.0
- Pulmonary fibrosis — n=157, PRR 37.0
- Haemoptysis — n=206, PRR 33.1
- Nodule — n=96, PRR 33.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Formoterol?
In FDA FAERS, the most frequently co-reported reaction terms for Formoterol are dyspnoea, asthma, cough, wheezing, pneumonia, fatigue. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Formoterol have an FDA boxed warning?
No. The FDA label retrieved for Formoterol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Formoterol causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 6c1a6c53-af85-4220-9ce3-2373e0928f7f, effective 20201215; matched on
openfda.generic_name.exact:"FORMOTEROL FUMARATE DIHYDRATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 404 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.