THEOPHYLLINE

N/A

Manufactured by Rhodes Pharmaceuticals L.P.

35,594 FDA adverse event reports analyzed

Last updated: 2026-04-14

About THEOPHYLLINE

THEOPHYLLINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Rhodes Pharmaceuticals L.P.. The most commonly reported adverse reactions for THEOPHYLLINE include DYSPNOEA, ASTHMA, PNEUMONIA, WHEEZING, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for THEOPHYLLINE.

Top Adverse Reactions

DYSPNOEA2,272 reports
ASTHMA1,941 reports
PNEUMONIA1,317 reports
WHEEZING1,306 reports
VOMITING1,099 reports
COUGH1,058 reports
DRUG HYPERSENSITIVITY823 reports
DRUG INEFFECTIVE756 reports
MALAISE751 reports
PAIN698 reports
OEDEMA667 reports
CHEST PAIN633 reports
NAUSEA628 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE625 reports
FATIGUE479 reports
DIZZINESS474 reports
PRODUCTIVE COUGH451 reports
PYREXIA444 reports
CONDITION AGGRAVATED442 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE427 reports
OFF LABEL USE418 reports
CHEST DISCOMFORT397 reports
RESPIRATORY TRACT INFECTION392 reports
DRUG INTERACTION388 reports
HYPERTENSION384 reports
HEADACHE379 reports
TOXICITY TO VARIOUS AGENTS357 reports
ANXIETY355 reports
DEATH352 reports
WEIGHT DECREASED350 reports
DIARRHOEA346 reports
FALL343 reports
ASTHENIA336 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES320 reports
ATRIAL FIBRILLATION316 reports
DEPRESSION313 reports
LOWER RESPIRATORY TRACT INFECTION305 reports
ARTHRALGIA298 reports
PAIN IN EXTREMITY297 reports
WEIGHT INCREASED297 reports
OBSTRUCTIVE AIRWAYS DISORDER280 reports
DYSPNOEA EXERTIONAL254 reports
INSOMNIA250 reports
NASAL CONGESTION250 reports
GASTROOESOPHAGEAL REFLUX DISEASE248 reports
RESPIRATORY FAILURE246 reports
CARDIAC FAILURE CONGESTIVE243 reports
TREMOR242 reports
ABDOMINAL PAIN239 reports
HYPOTENSION237 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION237 reports
NASOPHARYNGITIS235 reports
FULL BLOOD COUNT ABNORMAL231 reports
TACHYCARDIA231 reports
OVERDOSE230 reports
SINUSITIS223 reports
SOMNOLENCE216 reports
RASH213 reports
BLOOD PRESSURE INCREASED210 reports
BRONCHITIS210 reports
BACK PAIN206 reports
ANAEMIA195 reports
NASAL OEDEMA194 reports
OEDEMA PERIPHERAL194 reports
INFLUENZA190 reports
MYOCARDIAL INFARCTION189 reports
CONSTIPATION186 reports
RHINORRHOEA183 reports
DECREASED APPETITE180 reports
DIABETES MELLITUS178 reports
HEART RATE INCREASED178 reports
PRURITUS178 reports
OSTEOPOROSIS175 reports
HYPERSENSITIVITY173 reports
UPPER RESPIRATORY TRACT INFECTION171 reports
OXYGEN SATURATION DECREASED169 reports
LUNG DISORDER167 reports
HYPOKALAEMIA163 reports
PRODUCT DOSE OMISSION ISSUE163 reports
SEPSIS163 reports
GAIT DISTURBANCE162 reports
STRESS162 reports
RESPIRATORY DISORDER160 reports
SLEEP APNOEA SYNDROME159 reports
INTENTIONAL PRODUCT MISUSE158 reports
GOUT157 reports
ABDOMINAL DISTENSION154 reports
GENERAL PHYSICAL HEALTH DETERIORATION154 reports
DEHYDRATION153 reports
INFECTION153 reports
CONFUSIONAL STATE152 reports
DEPRESSED MOOD152 reports
RENAL FAILURE151 reports
SLEEP DISORDER149 reports
PALPITATIONS148 reports
RALES144 reports
URINARY TRACT INFECTION144 reports
CARDIAC FAILURE143 reports
MUSCLE SPASMS143 reports
CATARACT142 reports

Report Outcomes

Out of 11,722 classified reports for THEOPHYLLINE:

Serious 82.0%Non-Serious 18.0%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female6,423 (59.0%)
Male4,406 (40.5%)
Unknown55 (0.5%)

Reports by Age

Age 65702 reports
Age 68291 reports
Age 61284 reports
Age 69259 reports
Age 80259 reports
Age 70256 reports
Age 60239 reports
Age 72223 reports
Age 67220 reports
Age 75216 reports
Age 62214 reports
Age 64200 reports
Age 78197 reports
Age 76187 reports
Age 73185 reports
Age 56180 reports
Age 71180 reports
Age 74178 reports
Age 66165 reports
Age 77161 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with THEOPHYLLINE?

This profile reflects 35,594 FDA FAERS reports that mention THEOPHYLLINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for THEOPHYLLINE?

Frequently reported terms in FAERS include DYSPNOEA, ASTHMA, PNEUMONIA, WHEEZING, VOMITING, COUGH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures THEOPHYLLINE?

Labeling and FAERS entries often list Rhodes Pharmaceuticals L.P. in connection with THEOPHYLLINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.