Generic name
Aminophylline: adverse event reports filed with FDA
1,011 reports list it as a suspect or interacting product, 2004–2026. Class: Methylxanthine. Also reported as Aminophylline Injection Usp.
- 1,011
- reports as suspect product
- 0% of all reports · about 45 a year
- 159
- reports, 12 months to June 2026
- 150 in the 12 months before
- 95.5%
- marked serious by the reporter
- 95.3% across the class
- 10.4%
- record death among outcomes, as reported
- 105 reports · not verified by FDA
1,011 adverse event reports received by FDA list aminophylline, a generic name as a suspect or interacting product, from March 2004 to June 2026. A further 964 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 159 reports listed it, close to the 150 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 45 reports a year and 0% of the 20,646,523 reports in the database, and 20% of the reports for the methylxanthine class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded dyspnoea (36.3%), asthma (34.7%) and vomiting (34.3%). A report can list several reactions, so shares add to more than 100%; 250 different terms appear across these reports. Dyspnoea is recorded in 36.3% of these reports, about the same share as in the median methylxanthine drug (34.3%).
95.5% of the reports are marked serious by the reporter (95.3% across the class); 10.4% record death among the outcomes and 44.3% record hospitalisation, as reported. 46.8% of the reports came from other health professionals, and the largest patient age group is 65 to 74 (43.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Aminophylline reports recording the termmedian drug in methylxanthine
- Dyspnoeashortness of breath36.3%367
- Asthmaasthma34.7%351
- Vomitingbeing sick34.3%347
- Drug hypersensitivityan allergic-type reaction to a medicine30.8%311
- Pneumonialung infection29.8%301
- Oedemaswelling from fluid29.7%300
- Wheezingwheezing28.5%288
- Painpain, site not specified19.9%201
- Malaisegeneral feeling of being unwell16.4%166
- Off label useused for a purpose or in a way not on the label14.9%151
- Coughcough13.3%134
- Chest painchest pain13.1%132
- Respiratory tract infectiona respiratory infection13%131
- Overdosea dose above the recommended amount12.1%122
- Drug abusemisuse of a medicine11.7%118
- Drug ineffectivethe medicine did not work as expected11.7%118
- Nasal oedema9.8%99
- Lower respiratory tract infectiona chest infection9%91
- Rashskin rash8.5%86
- Drug interactionan interaction between medicines8.3%84
- Toxicity to various agentspoisoning or toxic effect of one or more substances8.3%84
- Abdominal discomfortstomach discomfort8.2%83
- Pulmonary pain8.2%83
- Hypotensionlow blood pressure8%81
- Arthropathy7.9%80
- Intentional product misusedeliberate use not as intended7.9%80
- Product dose omission issuea dose was missed7.9%80
- Falla fall7.1%72
- Blood calcium decreased6.8%69
Top 30 of 250 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the methylxanthine class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 5,061 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 17.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Asthma | 88 | 8.7% |
| Coronary artery disease | 46 | 4.5% |
| Depression | 23 | 2.3% |
| Capillary leak syndrome | 14 | 1.4% |
| Angina pectoris | 10 | 1% |
| Status asthmaticus | 10 | 1% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,011 reports.
In context
| Measure | Aminophylline | Methylxanthine | All reports |
|---|---|---|---|
| Reports as suspect product | 1,011 | 5,061 | 20,646,523 |
| Share of that pool | — | 20% | 0% |
| Reports, latest 12 months | 159 | — | 1,332,454 |
| Marked serious | 95.5% | 95.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 104 | 170 | 91 |
| Hospitalisation recorded, per 1,000 reports | 443 | 428 | 213 |
| Consumer-filed share | 18.5% | 18.7% | 45.8% |
| Top term, share of reports | Dyspnoea 36.3% | median 34.3% | 2.7% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the methylxanthine class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Theophylline | generic | 4,050 | 384 | 95.3% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Aminophylline reports
How many adverse event reports has FDA received for Aminophylline?
1,011 reports list Aminophylline as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 159 of them arrived in the latest 12 months. Another 964 list it only as a concomitant medication.
What reactions are recorded in Aminophylline reports?
dyspnoea (36.3%), asthma (34.7%), vomiting (34.3%), drug hypersensitivity (30.8%) and pneumonia (29.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Aminophylline was responsible.
How serious are the reports?
95.5% are marked serious by the reporter. Among the outcomes recorded, 10.4% of reports include death and 44.3% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (46.8%), physician (28.9%) and consumer or non-health professional (18.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Aminophylline rising?
159 reports in the 12 months to June 2026, close to the 150 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Aminophylline was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Aminophylline?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Aminophylline as a suspect or interacting product; reports listing it only as a concomitant medication (964) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.