THEOPHYLLINE

Theophylline Adverse Events Reported to the FDA Over Time

How are Theophylline adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Theophylline, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Theophylline is flagged as the suspect drug causing the adverse event.

Most Common Theophylline Adverse Events Reported to the FDA

What are the most common Theophylline adverse events reported to the FDA?

Completed Suicide	431 (3.45%)
Cardiac Arrest	202 (1.62%)
Drug Toxicity	181 (1.45%)
Overdose	164 (1.31%)
Vomiting	152 (1.22%)
Convulsion	144 (1.15%)
Tachycardia	142 (1.14%)
Hypotension	137 (1.1%)
Respiratory Arrest	133 (1.06%)
Nausea	129 (1.03%)
Dyspnoea	118 (.94%)
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Drug Interaction	115 (.92%)
Somnolence	113 (.9%)
Pyrexia	108 (.86%)
Death	107 (.86%)
Status Epilepticus	93 (.74%)
Poisoning	88 (.7%)
Intentional Overdose	86 (.69%)
Rhabdomyolysis	86 (.69%)
Cardio-respiratory Arrest	84 (.67%)
Loss Of Consciousness	84 (.67%)
Suicide Attempt	84 (.67%)
Drug Ineffective	83 (.66%)
Medication Error	83 (.66%)
Multiple Drug Overdose	81 (.65%)
Drug Exposure During Pregnancy	80 (.64%)
Blood Creatine Phosphokinase Increa...	72 (.58%)
Confusional State	70 (.56%)
Renal Failure Acute	67 (.54%)
Dizziness	66 (.53%)
Intentional Drug Misuse	65 (.52%)
Hypokalaemia	63 (.5%)
Drug Level Increased	61 (.49%)
Malaise	59 (.47%)
Anxiety	58 (.46%)
Depressed Level Of Consciousness	56 (.45%)
Heart Rate Increased	56 (.45%)
Condition Aggravated	54 (.43%)
Headache	53 (.42%)
Diarrhoea	48 (.38%)
Respiratory Failure	45 (.36%)
Tremor	45 (.36%)
Blood Pressure Decreased	44 (.35%)
Blood Pressure Increased	44 (.35%)
Drug Abuse	44 (.35%)
Pruritus	44 (.35%)
Palpitations	43 (.34%)
Asthma	42 (.34%)
Multiple Drug Overdose Intentional	42 (.34%)
Encephalopathy	41 (.33%)
Fall	41 (.33%)
Grand Mal Convulsion	41 (.33%)
Hypoglycaemia	41 (.33%)
Acute Respiratory Distress Syndrome	40 (.32%)
Hypertension	40 (.32%)
Sinus Tachycardia	40 (.32%)
Abdominal Pain	39 (.31%)
Depression	38 (.3%)
Fatigue	38 (.3%)
Toxic Epidermal Necrolysis	38 (.3%)
Coma	37 (.3%)
Stevens-johnson Syndrome	37 (.3%)
Ventricular Tachycardia	37 (.3%)
Bradycardia	36 (.29%)
Insomnia	35 (.28%)
Myalgia	35 (.28%)
Neuroleptic Malignant Syndrome	34 (.27%)
Oxygen Saturation Decreased	34 (.27%)
Urticaria	34 (.27%)
Pleural Effusion	33 (.26%)
Premature Baby	33 (.26%)
Unresponsive To Stimuli	33 (.26%)
Blood Potassium Decreased	32 (.26%)
Malignant Neoplasm Progression	32 (.26%)
Accidental Overdose	31 (.25%)
Agitation	31 (.25%)
Drug Level Above Therapeutic	31 (.25%)
Febrile Convulsion	31 (.25%)
Haemodialysis	31 (.25%)
Pain	31 (.25%)
Pneumonia	31 (.25%)
Rash	31 (.25%)
Atrial Fibrillation	30 (.24%)
Feeling Abnormal	30 (.24%)
Lethargy	30 (.24%)
Renal Failure	30 (.24%)
Asthenia	29 (.23%)
Chest Pain	29 (.23%)
Hyperhidrosis	29 (.23%)
Pulmonary Oedema	29 (.23%)
Supraventricular Tachycardia	29 (.23%)
Wheezing	29 (.23%)
Alanine Aminotransferase Increased	28 (.22%)
Blood Glucose Increased	28 (.22%)
Incorrect Dose Administered	28 (.22%)
Multi-organ Failure	28 (.22%)
Rash Erythematous	28 (.22%)
Sepsis	28 (.22%)
Ventricular Fibrillation	28 (.22%)
Arrhythmia	27 (.22%)
Aspartate Aminotransferase Increase...	27 (.22%)

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This graph shows the top adverse events submitted to the FDA for Theophylline, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Theophylline is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Theophylline

What are the most common Theophylline adverse events reported to the FDA?

Cardiac Arrhythmias	791 (6.33%)
Neurological	680 (5.44%)
Medication Errors	607 (4.86%)
Suicidal And Self-injurious Behavio...	545 (4.36%)
Respiratory	531 (4.25%)
Epidermal And Dermal Conditions	445 (3.56%)
Gastrointestinal Signs	435 (3.48%)
Chemical Injury And Poisoning	388 (3.1%)
Seizures	374 (2.99%)
Cardiac And Vascular Investigations	297 (2.38%)
Therapeutic And Nontherapeutic Effe...	274 (2.19%)
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Infections - Pathogen Unspecified	250 (2%)
Decreased And Nonspecific Blood Pre...	193 (1.54%)
Muscle	187 (1.5%)
Hepatic And Hepatobiliary	179 (1.43%)
Renal Disorders	175 (1.4%)
Toxicology And Therapeutic Drug Mon...	170 (1.36%)
Psychiatric	162 (1.3%)
Body Temperature Conditions	148 (1.18%)
Lower Respiratory Tract Disorders	142 (1.14%)
Metabolic, Nutritional And Blood Ga...	142 (1.14%)
Fatal Outcomes	132 (1.06%)
Electrolyte And Fluid Balance Condi...	124 (.99%)
Anxiety Disorders	117 (.94%)
Injuries	117 (.94%)
Movement Disorders	115 (.92%)
Bronchial Disorders	110 (.88%)
Deliria	105 (.84%)
Hematology Investigations	103 (.82%)
Enzyme	100 (.8%)
Bacterial Infectious	97 (.78%)
Hepatobiliary	97 (.78%)
Cardiac Disorder Signs	90 (.72%)
Physical Examination Topics	87 (.7%)
Water, Electrolyte And Mineral	87 (.7%)
Allergic Conditions	85 (.68%)
Central Nervous System Vascular	82 (.66%)
Coronary Artery	81 (.65%)
Neuromuscular	81 (.65%)
Gastrointestinal Motility And Defec...	77 (.62%)
Mental Impairment	70 (.56%)
Acid-base	67 (.54%)
Procedural And Device Related Injur...	67 (.54%)
Urinary Tract Signs	67 (.54%)
Glucose Metabolism Disorders	66 (.53%)
Musculoskeletal And Connective Tiss...	64 (.51%)
Appetite And General Nutritional	63 (.5%)
Headaches	57 (.46%)
Hematological And Lymphoid Tissue T...	56 (.45%)
Sleep Disorders	55 (.44%)
Gastrointestinal Hemorrhages	52 (.42%)
Ocular Neuromuscular	51 (.41%)
Vascular Hypertensive	51 (.41%)
Encephalopathies	50 (.4%)
White Blood Cell	50 (.4%)
Heart Failures	49 (.39%)
Depressed Mood Disorders	45 (.36%)
Angiedema And Urticaria	44 (.35%)
Joint	44 (.35%)
Myocardial	43 (.34%)
Skin Appendage Conditions	43 (.34%)
Lifestyle Issues	42 (.34%)
Upper Respiratory Tract Disorders	41 (.33%)
Neonatal And Perinatal Conditions	40 (.32%)
Cardiac Valve	38 (.3%)
Miscellaneous And Site Unspecified ...	37 (.3%)
Renal And Urinary Tract Investigati...	37 (.3%)
Vision	37 (.3%)
Administration Site Reactions	35 (.28%)
Anemias Nonhemolytic And Marrow Dep...	35 (.28%)
Disturbances In Thinking	35 (.28%)
Pleural	35 (.28%)
Therapeutic Procedures And Supporti...	32 (.26%)
Vascular	32 (.26%)
Gastrointestinal Ulceration And Per...	31 (.25%)
Neurological, Special Senses And Ps...	30 (.24%)
Skin Vascular Abnormalities	30 (.24%)
Tissue	30 (.24%)
Gastrointestinal Inflammatory Condi...	28 (.22%)
Increased Intracranial Pressure And...	28 (.22%)
Structural Brain	27 (.22%)
Viral Infectious	27 (.22%)
Arteriosclerosis, Stenosis, Vascula...	26 (.21%)
Changes In Physical Activity	26 (.21%)
Oral Soft Tissue Conditions	26 (.21%)
Bone And Joint Injuries	25 (.2%)
Coagulopathies And Bleeding Diathes...	25 (.2%)
Immunology And Allergy	25 (.2%)
Endocrine Investigations	23 (.18%)
Gastrointestinal Conditions	23 (.18%)
Mood Disorders	22 (.18%)
Obstetric And Gynecological Therape...	22 (.18%)
Cardiac And Vascular Disorders Cong...	21 (.17%)
Exocrine Pancreas Conditions	21 (.17%)
Platelet	21 (.17%)
Protein And Chemistry Analyses	19 (.15%)
Thyroid Gland	19 (.15%)
Anterior Eye Structural Change, Dep...	17 (.14%)
Embolism And Thrombosis	17 (.14%)
Gastrointestinal Vascular Condition...	17 (.14%)
Inner Ear And Viiith Cranial Nerve	16 (.13%)

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This graph shows the top categories of adverse events submitted to the FDA for Theophylline, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Theophylline is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.