Drug · FAERS side-effect profile with label screen
Aminophylline side effects: what 1,970 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,970 reports · 95% serious · 294 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Intravenous theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
FDA label, Indications and Usage
What it is
DESCRIPTION Aminophylline Injection, USP is a sterile, nonpyrogenic solution of aminophylline in water for injection. Aminophylline (dihydrate) is approximately 79% of anhydrous theophylline by weight.
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 adverse reaction 4Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 26
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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. 51 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 |
|---|---|---|---|---|---|---|
| Blood calcium decreased | 68 | 64.5 51.1–81.6ROR 66.8 · χ² 4,167 / p <1e-300 | 63.1 EB05 51.5 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious PRR 48.4 · ♀ 100% (drug 63%) | no trial data cached |
| Oedema | 307 | 60.7 54.8–67.3ROR 71.7 · χ² 17,911 / p <1e-300 | 60.1 EB05 54.7 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 45.7 · ♀ 99% (drug 63%) | no trial data cached |
| Wheezing | 324 | 58.6 53.0–64.8ROR 70.0 · χ² 18,240 / p <1e-300 | 58.1 EB05 53.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 48.2 · ♀ 96% (drug 63%) | no trial data cached |
| Respiratory tract infection | 140 | 57.7 49.2–67.7ROR 62.0 · χ² 7,710 / p <1e-300 | 57.0 EB05 49.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 42.4 · ♀ 99% (drug 63%) · 92% clinician | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 67 | 41.0 32.4–51.9ROR 42.4 · χ² 2,568 / p <1e-300 | 40.4 EB05 32.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 · ♀ 100% (drug 63%) | no trial data cached |
| Obesity | 59 | 39.5 30.7–50.8ROR 40.7 · χ² 2,169 / p <1e-300 | 38.9 EB05 31.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.6 · ♀ 98% (drug 63%) | no trial data cached |
| Asthma | 406 | 38.7 35.5–42.2ROR 48.5 · χ² 14,894 / p <1e-300 | 38.5 EB05 35.4 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 32.6 · ♀ 89% (drug 63%) | no trial data cached |
| Covid-19 pneumonia | 34 | 30.5 21.9–42.6ROR 31.0 · χ² 939 / p 1e-206 | 30.0 EB05 22.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.6 · ♀ 0% (drug 63%) | no trial data cached |
| Knee arthroplasty | 57 | 29.2 22.6–37.7ROR 30.0 · χ² 1,520 / p <1e-300 | 28.8 EB05 23.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 · ♀ 83% (drug 63%) | no trial data cached |
| Sedation | 70 | 28.7 22.8–36.1ROR 29.7 · χ² 1,838 / p <1e-300 | 28.4 EB05 23.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 · ♀ 98% (drug 63%) | no trial data cached |
| Lower respiratory tract infection | 99 | 23.3 19.2–28.2ROR 24.5 · χ² 2,091 / p <1e-300 | 23.2 EB05 19.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 | no trial data cached |
| Schizophrenia | 25 | 21.9 14.8–32.4ROR 22.2 · χ² 478 / p 3e-106 | 21.5 EB05 15.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · ♀ 14% (drug 63%) | no trial data cached |
| Depressed level of consciousness | 78 | 21.1 16.9–26.2ROR 21.9 · χ² 1,471 / p <1e-300 | 20.9 EB05 17.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 95% (drug 63%) | no trial data cached |
| Gastrointestinal pain | 19 | 18.5 11.8–28.9ROR 18.7 · χ² 297 / p 8e-67 | 18.0 EB05 11.9 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.9 | no trial data cached |
| Drug hypersensitivity | 321 | 17.6 15.9–19.5ROR 20.9 · χ² 5,054 / p <1e-300 | 17.6 EB05 16.0 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.1 · ♀ 99% (drug 63%) | no trial data cached |
| Cognitive disorder | 69 | 15.8 12.5–19.9ROR 16.3 · χ² 943 / p 2e-207 | 15.7 EB05 12.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · ♀ 100% (drug 63%) | no trial data cached |
| Arthropathy | 82 | 15.7 12.7–19.4ROR 16.3 · χ² 1,113 / p 3e-244 | 15.6 EB05 12.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Drug abuse | 119 | 15.2 12.7–18.0ROR 16.1 · χ² 1,564 / p <1e-300 | 15.1 EB05 12.9 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.2 · ♀ 86% (drug 63%) | no trial data cached |
| Dementia | 38 | 14.5 10.6–19.9ROR 14.8 · χ² 466 / p 1e-103 | 14.3 EB05 10.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Mitral valve incompetence | 15 | 14.1 8.5–23.4ROR 14.2 · χ² 170 / p 4e-39 | 13.1 EB05 7.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Contraindicated product administered | 39 | 13.8 10.1–18.8ROR 14.0 · χ² 450 / p 5e-100 | 13.5 EB05 10.1 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 10.3 · ♀ 3% (drug 63%) | no trial data cached |
| Caesarean section | 15 | 13.6 8.2–22.5ROR 13.7 · χ² 162 / p 2e-37 | 12.5 EB05 7.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Multiple organ dysfunction syndrome | 34 | 13.0 9.3–18.1ROR 13.2 · χ² 364 / p 2e-81 | 12.6 EB05 9.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 4% (drug 63%) | no trial data cached |
| Bladder disorder | 12 | 12.9 7.3–22.6ROR 12.9 · χ² 119 / p 4e-28 | 11.3 EB05 6.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Chronic obstructive pulmonary disease | 60 | 12.3 9.6–15.7ROR 12.6 · χ² 610 / p 5e-135 | 12.0 EB05 9.6 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 · ♀ 19% (drug 63%) | no trial data cached |
| Pneumonia (lung infection) | 367 | 12.1 11.0–13.3ROR 14.6 · χ² 3,779 / p <1e-300 | 12.1 EB05 11.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 92% (drug 63%) | no trial data cached |
| Tachypnoea | 15 | 11.8 7.1–19.5ROR 11.9 · χ² 138 / p 5e-32 | 10.5 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 17 | 11.5 7.2–18.5ROR 11.6 · χ² 152 / p 3e-35 | 10.4 EB05 6.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Ejection fraction decreased | 16 | 10.9 6.7–17.8ROR 11.0 · χ² 135 / p 2e-31 | 9.7 EB05 5.9 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.3 | no trial data cached |
| Bronchospasm (airway tightening) | 14 | 10.4 6.2–17.6ROR 10.5 · χ² 110 / p 5e-26 | 8.9 EB05 5.3 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.9 | no trial data cached |
| Mobility decreased | 70 | 10.4 8.3–13.1ROR 10.8 · χ² 588 / p 4e-130 | 10.1 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · ♀ 98% (drug 63%) | no trial data cached |
| Intentional product misuse | 82 | 10.1 8.1–12.4ROR 10.5 · χ² 662 / p 3e-146 | 9.8 EB05 8.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 13.8 | no trial data cached |
| Lactic acidosis | 30 | 10.0 7.0–14.2ROR 10.1 · χ² 233 / p 7e-53 | 9.3 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 96% clinician | no trial data cached |
| Sinus tachycardia | 13 | 9.8 5.7–16.8ROR 9.8 · χ² 94 / p 2e-22 | 8.2 EB05 4.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Chest pain | 157 | 9.0 7.8–10.5ROR 9.7 · χ² 1,119 / p 1e-245 | 8.9 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · ♀ 93% (drug 63%) | no trial data cached |
| Oral pain | 19 | 9.0 5.8–14.1ROR 9.1 · χ² 127 / p 8e-30 | 7.9 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Irritable bowel syndrome | 18 | 9.0 5.7–14.2ROR 9.0 · χ² 120 / p 4e-28 | 7.8 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Vomiting | 384 | 8.7 8.0–9.5ROR 10.6 · χ² 2,676 / p <1e-300 | 8.7 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · ♀ 89% (drug 63%) | no trial data cached |
| Dyspnoea (shortness of breath) | 462 | 8.7 8.0–9.4ROR 11.1 · χ² 3,226 / p <1e-300 | 8.6 EB05 8.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 91% (drug 63%) | no trial data cached |
| Multi-organ failure | 14 | 8.5 5.0–14.3ROR 8.6 · χ² 85 / p 1e-20 | 7.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | 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) | 462 | 8.7 8.0–9.4ROR 11.1 · χ² 3,226 / p <1e-300 | 8.6 EB05 8.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 91% (drug 63%) | no trial data cached |
| Asthma | 406 | 38.7 35.5–42.2ROR 48.5 · χ² 14,894 / p <1e-300 | 38.5 EB05 35.4 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 32.6 · ♀ 89% (drug 63%) | no trial data cached |
| Vomiting | 384 | 8.7 8.0–9.5ROR 10.6 · χ² 2,676 / p <1e-300 | 8.7 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · ♀ 89% (drug 63%) | no trial data cached |
| Pneumonia (lung infection) | 367 | 12.1 11.0–13.3ROR 14.6 · χ² 3,779 / p <1e-300 | 12.1 EB05 11.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 92% (drug 63%) | no trial data cached |
| Wheezing | 324 | 58.6 53.0–64.8ROR 70.0 · χ² 18,240 / p <1e-300 | 58.1 EB05 53.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 48.2 · ♀ 96% (drug 63%) | no trial data cached |
| Drug hypersensitivity | 321 | 17.6 15.9–19.5ROR 20.9 · χ² 5,054 / p <1e-300 | 17.6 EB05 16.0 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.1 · ♀ 99% (drug 63%) | no trial data cached |
| Oedema | 307 | 60.7 54.8–67.3ROR 71.7 · χ² 17,911 / p <1e-300 | 60.1 EB05 54.7 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 45.7 · ♀ 99% (drug 63%) | no trial data cached |
| Malaise (feeling unwell) | 195 | 4.7 4.1–5.4ROR 5.1 · χ² 581 / p 1e-128 | 4.7 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 86% (drug 63%) | no trial data cached |
| Cough | 171 | 6.5 5.6–7.5ROR 7.0 · χ² 802 / p 1e-176 | 6.4 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 90% (drug 63%) | no trial data cached |
| Chest pain | 157 | 9.0 7.8–10.5ROR 9.7 · χ² 1,119 / p 1e-245 | 8.9 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · ♀ 93% (drug 63%) | no trial data cached |
| Respiratory tract infection | 140 | 57.7 49.2–67.7ROR 62.0 · χ² 7,710 / p <1e-300 | 57.0 EB05 49.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 42.4 · ♀ 99% (drug 63%) · 92% clinician | no trial data cached |
| Overdose | 134 | 6.6 5.6–7.8ROR 7.0 · χ² 636 / p 1e-140 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 | no trial data cached |
| Drug abuse | 119 | 15.2 12.7–18.0ROR 16.1 · χ² 1,564 / p <1e-300 | 15.1 EB05 12.9 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.2 · ♀ 86% (drug 63%) | no trial data cached |
| Hypotension (low blood pressure) | 114 | 6.1 5.1–7.2ROR 6.4 · χ² 481 / p 6e-107 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Drug interaction | 103 | 6.9 5.7–8.3ROR 7.2 · χ² 519 / p 4e-115 | 6.7 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 | 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.
- Wheezing — n=324, PRR 58.6
- Respiratory tract infection — n=140, PRR 57.7
- Orthostatic hypotension — n=67, PRR 41.0
- Obesity — n=59, PRR 39.5
- Covid-19 pneumonia — n=34, PRR 30.5
- Knee arthroplasty — n=57, PRR 29.2
- Sedation — n=70, PRR 28.7
- Lower respiratory tract infection — n=99, PRR 23.3
- Schizophrenia — n=25, PRR 21.9
- Depressed level of consciousness — n=78, PRR 21.1
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 Aminophylline?
In FDA FAERS, the most frequently co-reported reaction terms for Aminophylline are dyspnoea, asthma, vomiting, pneumonia, wheezing, drug hypersensitivity. 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 Aminophylline have an FDA boxed warning?
No. The FDA label retrieved for Aminophylline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Aminophylline 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 6bca324f-6999-4c16-e053-2a91aa0aee45, effective 20230530; matched on
openfda.generic_name.exact:"AMINOPHYLLINE") - 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, 91 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.