Theophylline adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Theophylline
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Methylxanthine
Also reported as: Theophylline Sustained Release, Theophylline Cr Tablet, Theophylline Cr

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 4,050 adverse event reports that name Theophylline. In these reports the drug is a suspect or interacting product.

In the same period, 7,566 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 384 reports in the 12 months to June 2026 and 327 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 384 (under 0.1%) name Theophylline. Reports from consumers or other non-health professionals were 18.7% of the reports that name Theophylline and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Theophylline is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 86 reports that name Theophylline.
In January to March 2026, FDA received 103.
In April to June 2025, FDA received 104.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 632 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 4,030 of the 4,050 reports (99.5%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 632 terms.

Reaction terms in the reports that name Theophylline, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,050 reports
Asthma	1,424	35.2%
Dyspnoeashortness of breath	1,314	32.4%
Wheezing	1,162	28.7%
Vomitingbeing sick	934	23.1%
Pneumonialung infection	864	21.3%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	854	21.1%
Cough	717	17.7%
Oedemaswelling from fluid	682	16.8%
Malaisegeneral feeling of being unwell	545	13.5%
Chest pain	463	11.4%
Painpain, site not specified	449	11.1%
Therapeutic product effect incomplete	416	10.3%
Respiratory tract infectiona respiratory infection	382	9.4%
Toxicity to various agentspoisoning or toxic effect of one or more substances	308	7.6%
Loss of personal independence in daily activities	301	7.4%
Productive cougha cough with phlegm	292	7.2%
Drug ineffectivethe medicine did not work as expected	284	7%
Drug interactionan interaction between medicines	254	6.3%
Lower respiratory tract infectiona chest infection	249	6.1%
Chest discomfort	237	5.9%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	234	5.8%
Sleep disorder due to a general medical condition	234	5.8%
Nasal oedema	232	5.7%
Nauseafeeling sick	227	5.6%
Off label useused for a purpose or in a way not on the label	218	5.4%
Full blood count abnormal	213	5.3%
Obstructive airways disorder	205	5.1%
Hypertensionhigh blood pressure	199	4.9%
Pyrexiafever	194	4.8%
Atrial fibrillationan irregular heart rhythm	185	4.6%
Condition aggravatedthe condition being treated got worse	182	4.5%
Overdosea dose above the recommended amount	181	4.5%
Nasal congestiona blocked nose	178	4.4%
Dizzinesslight-headedness or unsteadiness	173	4.3%
Anxiety	156	3.9%
Tachycardiafast heart rate	156	3.9%
Depressionlow mood	155	3.8%
Dyspnoea exertional	150	3.7%
Gastrooesophageal reflux diseaseacid reflux	147	3.6%
Intentional product misusedeliberate use not as intended	146	3.6%
Rhinorrhoeaa runny nose	138	3.4%
Pain in extremitypain in an arm or leg	127	3.1%
Weight increasedweight gain	126	3.1%
Abdominal painstomach or belly pain	124	3.1%
Tremorshaking	124	3.1%
Blood count abnormal	123	3%
Drug abusemisuse of a medicine	121	3%
Gout	121	3%
Depressed moodlow mood	119	2.9%
Product dose omission issuea dose was missed	119	2.9%

Download all 632 terms of Theophylline (CSV)

The counts add to more than 4,050 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Theophylline with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Theophylline (this page)	Generic name	4,050
Theophylline anhydrous	Generic name	218

Sum of the separately reported names: 4,268. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Theophylline, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	140	135	59	9	47	1	5	39	5
2005	117	112	43	5	54	2	2	31	5
2006	113	109	21	1	32	0	1	67	4
2007	75	72	18	7	38	2	0	24	3
2008	128	125	40	14	52	1	0	52	3
2009	95	94	33	13	60	2	0	30	1
2010	92	91	37	10	47	1	0	28	1
2011	72	72	21	10	28	6	0	25	0
2012	57	55	11	6	27	5	0	31	2
2013	77	68	15	4	29	2	0	31	9
2014	83	68	3	4	25	3	15	33	15
2015	109	99	48	9	30	1	0	40	10
2016	94	70	26	7	45	1	0	28	24
2017	125	92	17	15	40	3	0	66	33
2018	169	154	31	30	94	11	7	110	15
2019	213	183	14	25	100	1	1	140	30
2020	231	217	27	22	130	2	0	146	14
2021	336	328	12	23	175	1	0	277	8
2022	337	332	43	36	170	1	0	264	5
2023	309	306	51	43	129	29	3	258	3
2024	312	311	58	43	79	34	13	287	1
2025	438	437	86	91	149	72	42	420	1
2026	328	328	43	34	136	24	17	304	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Theophylline, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Theophylline, by the year in which FDA received them
Year	Reports
2004	132
2005	118
2006	114
2007	79
2008	130
2009	96
2010	94
2011	67
2012	76
2013	74
2014	82
2015	120
2016	100
2017	152
2018	217
2019	242
2020	271
2021	438
2022	288
2023	300
2024	317
2025	354
2026	189

Reports that name Theophylline, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Theophylline
Age	Reports	Share
Under 2	46	1.1%
2 to 11	87	2.1%
12 to 17	38	0.9%
18 to 44	416	10.3%
45 to 64	757	18.7%
65 to 74	1,191	29.4%
75 and over	651	16.1%
Age not given	864	21.3%

Sex of the patient in the reports that name Theophylline
Sex	Reports	Share
Female	2,252	55.6%
Male	1,318	32.5%
Unknown or not given	480	11.9%

Type of reporter in the reports that name Theophylline
Reporter	Reports	Share
Physician	1,086	26.8%
Pharmacist	190	4.7%
Other health professional	1,744	43.1%
Lawyer	2	under 0.1%
Consumer or non-health professional	757	18.7%
Not given	271	6.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 18% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Theophylline record
Indication as recorded (MedDRA)	Reports	Share
Asthma	462	11.4%
Chronic obstructive pulmonary disease	252	6.2%
Depression	52	1.3%
Bronchospasm	28	0.7%
Off label use	28	0.7%
Bronchitis chronic	21	0.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,050 reports.

Drugs in the same reports

Other drugs that the reports of Theophylline name, in any role, in order of name
Drug	Reports that name the two
Advair Hfa	818
Aspirin	788
Clonazepam	722
Ergocalciferol	781
Omalizumab	656
Prednisone	1,408
Risedronate sodium	652
Rituximab	650
Singulair	879
Tramadol hydrochloride	595

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Theophylline anhydrous same ingredient
Aminophylline same class
Thalomid next in the A to Z list
Thalidomide Celgene next in the A to Z list
Theralen next in the A to Z list
Thalidomide next in the A to Z list
Theralene next in the A to Z list
Tezspire next in the A to Z list
Therapeutic Radiopharmaceuticals next in the A to Z list
Tezepelumab next in the A to Z list
Therapy next in the A to Z list
Teveten next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for TheophyllineThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Theophylline: adverse event reports that FDA received. https://reportedreactions.com/drug/theophylline/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Theophylline as a suspect or interacting product. The 7,566 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Theophylline was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Theophylline?

No. It is a count of what people reported to FDA: 4,050 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (43.1%), physician (26.8%) and consumer or non-health professional (18.7%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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