Terbutaline side effects: what 1,823 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Terbutaline Sulfate (Terbutaline Sulfate)
Who reports
1,823 reports · 96% serious · 166 with death outcome · 58% female
Used for
Terbutaline Sulfate Injection, USP is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
What it is
DESCRIPTION Terbutaline Sulfate, USP, the active ingredient of Terbutaline Sulfate Injection, USP, is a beta‑adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration.
Boxed warning
PROLONGED TOCOLYSIS Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48-72 hours). In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 90 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Full blood count abnormal | 85 | 93.5 75.9–115.1ROR 98.0 · χ² 7,625 / p <1e-300 | 90.9 EB05 75.8 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 74.0 · ♀ 82% (drug 58%) | no trial data cached |
| Obstructive airways disorder | 82 | 85.1 68.8–105.3ROR 89.1 · χ² 6,686 / p <1e-300 | 82.9 EB05 68.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 52.8 | no trial data cached |
| Sleep disorder due to a general medical condition | 118 | 84.5 71.0–100.7ROR 90.3 · χ² 9,594 / p <1e-300 | 82.8 EB05 71.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 99.8 · ♀ 84% (drug 58%) | no trial data cached |
| Decreased activity | 47 | 50.7 38.2–67.2ROR 52.0 · χ² 2,230 / p <1e-300 | 49.5 EB05 38.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 45.6 · ♀ 80% (drug 58%) | no trial data cached |
| Wheezing | 256 | 50.0 44.6–56.0ROR 58.0 · χ² 12,222 / p <1e-300 | 49.6 EB05 44.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 41.1 | no trial data cached |
| Middle insomnia | 79 | 49.1 39.5–60.9ROR 51.2 · χ² 3,658 / p <1e-300 | 48.3 EB05 40.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 63.9 · ♀ 85% (drug 58%) | no trial data cached |
| Emphysema | 35 | 39.9 28.7–55.4ROR 40.7 · χ² 1,285 / p 1e-281 | 39.0 EB05 29.3 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 27.0 · ♀ 100% (drug 58%) | no trial data cached |
| Asthma | 378 | 38.9 35.6–42.6ROR 48.8 · χ² 13,953 / p <1e-300 | 38.7 EB05 35.6 · IC025 +5.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 32.3 | no trial data cached |
| Sputum discoloured | 29 | 35.4 24.7–50.8ROR 35.9 · χ² 933 / p 4e-205 | 34.6 EB05 25.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.7 | no trial data cached |
| Loss of personal independence in daily activities | 140 | 34.0 29.0–39.8ROR 36.7 · χ² 4,442 / p <1e-300 | 33.7 EB05 29.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 26.8 · ♀ 78% (drug 58%) | no trial data cached |
| Tooth abscess | 30 | 33.9 23.7–48.3ROR 34.4 · χ² 922 / p 8e-203 | 33.1 EB05 24.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 26.6 · ♀ 100% (drug 58%) | no trial data cached |
| Blood count abnormal | 41 | 30.7 22.7–41.6ROR 31.4 · χ² 1,148 / p 6e-252 | 30.3 EB05 23.3 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 25.8 · 71% consumer | no trial data cached |
| Musculoskeletal chest pain | 40 | 29.8 21.9–40.5ROR 30.4 · χ² 1,082 / p 2e-237 | 29.3 EB05 22.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 25.4 · ♀ 94% (drug 58%) | no trial data cached |
| Respiratory tract congestion | 38 | 27.5 20.1–37.7ROR 28.1 · χ² 944 / p 1e-207 | 27.1 EB05 20.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 37.2 | no trial data cached |
| Bacterial infection | 41 | 25.4 18.8–34.5ROR 26.0 · χ² 937 / p 4e-206 | 25.1 EB05 19.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 · ♀ 97% (drug 58%) | no trial data cached |
| Drug exposure during pregnancy | 74 | 24.7 19.8–30.9ROR 25.7 · χ² 1,660 / p <1e-300 | 24.5 EB05 20.2 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 15.1 · 93% clinician | no trial data cached |
| Caesarean section | 25 | 24.5 16.6–36.2ROR 24.8 · χ² 539 / p 1e-119 | 24.1 EB05 17.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 | no trial data cached |
| Blood iron decreased | 22 | 21.5 14.2–32.6ROR 21.8 · χ² 409 / p 3e-91 | 21.1 EB05 14.6 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 16.8 | no trial data cached |
| Feeding disorder | 36 | 20.8 15.1–28.8ROR 21.2 · χ² 659 / p 2e-145 | 20.6 EB05 15.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · ♀ 100% (drug 58%) | no trial data cached |
| Product administration error | 36 | 20.8 15.0–28.7ROR 21.2 · χ² 658 / p 2e-145 | 20.5 EB05 15.5 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 30.5 · ♀ 100% (drug 58%) | no trial data cached |
| Therapeutic product effect incomplete | 124 | 20.2 17.0–24.0ROR 21.6 · χ² 2,248 / p <1e-300 | 20.1 EB05 17.3 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 22.8 · ♀ 81% (drug 58%) | no trial data cached |
| Productive cough (cough with phlegm) | 79 | 19.2 15.5–23.9ROR 20.1 · χ² 1,348 / p 3e-295 | 19.1 EB05 15.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 17.2 | no trial data cached |
| Blood pressure systolic increased | 32 | 18.8 13.3–26.5ROR 19.1 · χ² 522 / p 9e-116 | 18.6 EB05 13.7 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 11.9 · ♀ 24% (drug 58%) | no trial data cached |
| Body temperature decreased | 16 | 18.6 11.4–30.2ROR 18.7 · χ² 248 / p 3e-56 | 18.0 EB05 11.3 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 12.4 | no trial data cached |
| Bronchospasm (airway tightening) | 23 | 18.5 12.3–27.8ROR 18.7 · χ² 363 / p 3e-81 | 18.1 EB05 12.6 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 11.2 | no trial data cached |
| Renal tubular necrosis | 15 | 17.6 10.6–29.1ROR 17.7 · χ² 218 / p 1e-49 | 16.9 EB05 10.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Dyspnoea exertional | 52 | 16.0 12.2–20.9ROR 16.4 · χ² 714 / p 1e-157 | 15.8 EB05 12.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Fungal infection | 46 | 15.9 12.0–21.2ROR 16.3 · χ² 628 / p 7e-139 | 15.7 EB05 12.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · ♀ 100% (drug 58%) | no trial data cached |
| Nasal congestion (stuffy nose) | 76 | 15.0 12.0–18.6ROR 15.6 · χ² 977 / p 9e-215 | 14.8 EB05 12.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 | no trial data cached |
| Tachypnoea | 16 | 13.6 8.3–22.2ROR 13.7 · χ² 174 / p 4e-40 | 12.6 EB05 7.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Adrenal insufficiency | 14 | 13.5 8.0–22.7ROR 13.6 · χ² 149 / p 1e-34 | 12.3 EB05 7.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Ligament sprain | 11 | 12.8 7.1–23.1ROR 12.9 · χ² 108 / p 1e-25 | 11.1 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Respiratory distress | 30 | 12.5 8.8–17.8ROR 12.7 · χ² 306 / p 7e-69 | 12.0 EB05 8.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 20 | 12.5 8.1–19.3ROR 12.6 · χ² 199 / p 1e-45 | 11.6 EB05 7.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 95% clinician | no trial data cached |
| Upper gastrointestinal haemorrhage | 18 | 12.3 7.8–19.4ROR 12.4 · χ² 175 / p 3e-40 | 11.3 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Secretion discharge | 13 | 12.1 7.0–20.8ROR 12.2 · χ² 122 / p 1e-28 | 10.6 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 | no trial data cached |
| Sinus congestion | 14 | 11.9 7.1–20.1ROR 12.0 · χ² 129 / p 3e-30 | 10.5 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Obesity | 16 | 11.5 7.1–18.8ROR 11.6 · χ² 144 / p 2e-33 | 10.3 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Pulmonary fibrosis | 19 | 11.4 7.3–17.9ROR 11.6 · χ² 171 / p 2e-39 | 10.4 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Foot deformity | 11 | 11.4 6.3–20.6ROR 11.5 · χ² 94 / p 1e-22 | 9.5 EB05 5.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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) | 423 | 8.6 7.9–9.4ROR 10.9 · χ² 2,913 / p <1e-300 | 8.6 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Asthma | 378 | 38.9 35.6–42.6ROR 48.8 · χ² 13,953 / p <1e-300 | 38.7 EB05 35.6 · IC025 +5.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 32.3 | no trial data cached |
| Wheezing | 256 | 50.0 44.6–56.0ROR 58.0 · χ² 12,222 / p <1e-300 | 49.6 EB05 44.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 41.1 | no trial data cached |
| Pneumonia (lung infection) | 206 | 7.3 6.4–8.3ROR 8.1 · χ² 1,138 / p 1e-249 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Cough | 204 | 8.4 7.4–9.6ROR 9.3 · χ² 1,338 / p 3e-293 | 8.3 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Loss of personal independence in daily activities | 140 | 34.0 29.0–39.8ROR 36.7 · χ² 4,442 / p <1e-300 | 33.7 EB05 29.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 26.8 · ♀ 78% (drug 58%) | no trial data cached |
| Therapeutic product effect incomplete | 124 | 20.2 17.0–24.0ROR 21.6 · χ² 2,248 / p <1e-300 | 20.1 EB05 17.3 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 22.8 · ♀ 81% (drug 58%) | no trial data cached |
| Sleep disorder due to a general medical condition | 118 | 84.5 71.0–100.7ROR 90.3 · χ² 9,594 / p <1e-300 | 82.8 EB05 71.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 99.8 · ♀ 84% (drug 58%) | no trial data cached |
| Nasopharyngitis (common cold) | 109 | 6.8 5.7–8.1ROR 7.2 · χ² 537 / p 5e-119 | 6.6 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · ♀ 80% (drug 58%) | no trial data cached |
| Blood pressure increased | 100 | 7.5 6.2–9.1ROR 7.9 · χ² 562 / p 2e-124 | 7.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.6 | no trial data cached |
| Chest discomfort | 100 | 11.3 9.3–13.7ROR 11.9 · χ² 931 / p 9e-205 | 11.1 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 | no trial data cached |
| Full blood count abnormal | 85 | 93.5 75.9–115.1ROR 98.0 · χ² 7,625 / p <1e-300 | 90.9 EB05 75.8 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 74.0 · ♀ 82% (drug 58%) | no trial data cached |
| Heart rate increased | 83 | 9.6 7.8–11.9ROR 10.1 · χ² 637 / p 7e-141 | 9.4 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.3 | no trial data cached |
| Obstructive airways disorder | 82 | 85.1 68.8–105.3ROR 89.1 · χ² 6,686 / p <1e-300 | 82.9 EB05 68.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 52.8 | no trial data cached |
| Influenza | 79 | 8.1 6.6–10.1ROR 8.5 · χ² 489 / p 1e-108 | 7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | 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.
- Obstructive airways disorder — n=82, PRR 85.1
- Sleep disorder due to a general medical condition — n=118, PRR 84.5
- Decreased activity — n=47, PRR 50.7
- Wheezing — n=256, PRR 50.0
- Middle insomnia — n=79, PRR 49.1
- Sputum discoloured — n=29, PRR 35.4
- Loss of personal independence in daily activities — n=140, PRR 34.0
- Tooth abscess — n=30, PRR 33.9
- Musculoskeletal chest pain — n=40, PRR 29.8
- Respiratory tract congestion — n=38, PRR 27.5
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 Terbutaline?
In FDA FAERS, the most frequently co-reported reaction terms for Terbutaline are dyspnoea, asthma, wheezing, pneumonia, cough, loss of personal independence in daily activities. 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 Terbutaline have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: PROLONGED TOCOLYSIS Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48-72 hours). In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting.
Do FAERS signals prove that Terbutaline 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 0f4d3249-e022-40b6-b93d-f605e8522207, effective 20201001; matched on
openfda.generic_name.exact:"TERBUTALINE SULFATE") - 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, 130 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.