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What the label lists and what reports show

Aminophylline side effects

Aminophylline's FDA label lists its adverse reactions in its own words. FAERS holds 1,970 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (462 reports).

  • Generic listed

Check it at the source: the aminophylline FDA label on DailyMed (effective May 22, 2026, Hospira, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Adverse reactions associated with theophylline are generally mild when peak serum theophylline concentrations are <20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum theophylline concentrations exceed 20 mcg/mL, however, theophylline produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal (see OVERDOSAGE ). Other adverse reactions that have been reported at serum theophylline concentrations <20 mcg/mL include diarrhea, irritability, restlessness, fine skeletal muscle tremors, and transient diuresis. In patients with hypoxia secondary to COPD, multifocal atrial tachycardia and flutter have been reported at serum theophylline concentrations ≥15 mcg/mL. …

Table IV. Manifestations of Theophylline Toxicity* Percentage of Patients Reported With Sign or Symptom

Study 1 (n=157)Study 2 (n=14)Study 1 (n=92)Study 2 (n=102)
NR0NR**6
NR21NR**12
NR0NR**14
NR0NR**2
NR7NR**0
NR21NR**8
NR64NR**21
NR7NR**11

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

Source: FDA drug label, Hospira, Inc., effective May 22, 2026 (SPL set 9a663ef3-881f-48bd-2689-3713b24545c2), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,970 reports list aminophylline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 294 are coded as a death and 919 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Dyspnoea462
  • Asthma (a use or a product term, not a reaction)405
  • Vomiting (named in the label)384
  • Pneumonia367
  • Wheezing324
  • Drug Hypersensitivity321
  • Oedema307
  • Pain218
  • Malaise195
  • Drug Ineffective (a use or a product term, not a reaction)176
  • Cough171
  • Off Label Use (a use or a product term, not a reaction)168
  • Chest Pain157
  • Respiratory Tract Infection140
  • Overdose (a use or a product term, not a reaction)134
  • Drug Abuse119
  • Hypotension (named in the label)114
  • Drug Interaction (a use or a product term, not a reaction)103
  • Rash102
  • Lower Respiratory Tract Infection99
  • Nasal Oedema99
  • Toxicity To Various Agents88
  • Abdominal Discomfort86
  • Pulmonary Pain85
  • Fall84

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Aminophylline: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions