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Theophylline Side Effects

The most commonly reported side effects of theophylline include dyspnoea, asthma, and wheezing, based on 15,088 FDA adverse event reports from 2004 to 2025. 4.5% of reports found the drug to be ineffective.

Theophylline side effects

Percentages show how often each reaction appears relative to total reports for theophylline.

1
Dyspnoea14.0%2,113
2
Asthma13.1%1,984
3
Wheezing9.0%1,359
4
Pneumonia8.6%1,302
5
Cough7.0%1,058
6
Vomiting6.5%986
7
Drug Hypersensitivity5.6%852
8
Malaise5.0%747
9
Drug Ineffective4.5%683
10
Oedema4.4%661
11
Pain4.3%647
12
Chest Pain3.7%563
13
Dyspnoea3.5%534
14
Chronic Obstructive Pulmonary Disease3.5%525
15
Productive Cough3.3%494

These are voluntary reports and do not establish that theophylline caused these reactions.

Report severity

82.5%Serious12,453 reports
44.8%Hospitalizations6,757 reports
14.7%Fatal2,212 reports

Seriousness is determined by the reporter, not by OpenClaim.

Theophylline drug interactions

Other drugs that appear in adverse event reports alongside theophylline. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Fluticasone12.9%1,953
2
Omalizumab10.9%1,651
3
Montelukast-sodium10.6%1,597
4
Prednisone10.1%1,524
5
Albuterol9.5%1,440
6
Salmeterol-xinafoate8.7%1,318
7
Tiotropium-bromide8.2%1,240
8
Aspirin5.7%859
9
Amlodipine5.6%845
10
Budesonide5.6%839
11
Ciprofloxacin5.1%771
12
Moxifloxacin-hydrochloride5.0%757
13
Ipratropium-bromide5.0%748
14
Rosuvastatin5.0%748
15
Ergocalciferol4.6%690

Taken alongside

1
Albuterol28.2%4,262
2
Montelukast-sodium17.5%2,638
3
Fluticasone16.8%2,539
4
Prednisone13.9%2,091
5
Furosemide13.0%1,961
6
Tiotropium-bromide12.7%1,923
7
Salmeterol-xinafoate11.8%1,785
8
Aspirin10.8%1,624
9
Budesonide10.0%1,506
10
Ipratropium-bromide9.9%1,490
11
Acetaminophen9.8%1,479
12
Omeprazole9.4%1,420
13
Formoterol8.5%1,284
14
Levothyroxine-sodium7.5%1,128
15
Amlodipine6.9%1,034

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports theophylline side effects

54.8% of theophylline adverse event reports involve female patients and 38.2% involve male patients. The largest age group is elderly at 54%. These figures reflect who reports side effects, not underlying risk.

Sex

Female54.8%
Male38.2%
Unknown7.1%

Age group

< 21.2%
2–111.7%
12–171.1%
18–6442.2%
65+53.8%

What is theophylline used for

Conditions and purposes for which patients were taking theophylline when the adverse event was reported.

Abortion InducedAccidental Exposure To ProductAccidental Exposure To Product By ChildAcidosisAcute Myeloid LeukaemiaAcute Myeloid LeukemiaAcute Myocardial InfarctionAcute Respiratory Distress SyndromeAcute Respiratory FailureAdcy5-related DyskinesiaAddison^s DiseaseAdrenocortical Insufficiency ChronicAdult T-cell Lymphoma/leukaemiaAlpha-1 Anti-trypsin DeficiencyAnaesthesia

Showing 15 of 297 indications

Theophylline brand names and reporting trend

Theophylline is sold under brand names including Theo-24, Synophylate.

Brand names

Theo-2413,658
Synophylate114

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking theophylline with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.