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J Am Med Inform Assoc 16:328-337 doi:10.1197/jamia.M3028
  • Original Investigation

Active Computerized Pharmacovigilance Using Natural Language Processing, Statistics, and Electronic Health Records: A Feasibility Study

Table 3

Qualitative Evaluation

Associations Detected‡
Drug* (Treatment Indications) Reference Standard† Known ADEs Indication Associations Remote Indication Associations Unknown Associations
Ibuprofen (pain of rheumatoid arthritis, osteoarthritis, menstrual cramps, or mild to moderate pain) constipation, diarrhea, dizziness, gas, headache, heartburn, nausea, stomach pain or upset headache, achalasia, nausea, constipation pain, pleuritic pain, chest pain, ache, referred pain, apyrexial, fever, chill, night sweat, hot flush joint swelling, lesion, bacterial abscess, erythema, oral lesion, hemoptysis
ACE inhibitors (hypertension and congestive heart failure) cough, diarrhea, dizziness, headache, tiredness cough, lethargy, dizziness, diarrhea, headache chest pain, shortness of breath, syncope, orthopnea, pain hyponatremia, decreased body weight, vomiting, asymptomatic
Rosiglitazone (diabetes) headache, weight gain, symptoms of heart failure headache, chest pain, left atrial hypertrophy, shortness of breath syncope, vertigo tremor, pins and needle, cyanosis, colic abdominal non-productive cough, erythema
Bupropion (depression and smoking cessation aid) constipation, dizziness, drowsiness, dry mouth, headache, pruritus increased sweating, loss of appetite, nausea, vomiting, nervousness, restlessness, taste changes, trouble sleeping, weight changes, seizure, tinnitus suicidal thoughts dizziness, abnormal sensation, difficulty, drugged state, fatigue, constipation sleeplessness, seizure, tinnitus, pruritus feeling suicidal suicidal, visual hallucinations, moody, emotional, tremor, nightmare motor retardation, fall, jumpy, stiffness, early satiety, extrapyramidal sign, energy increased, malingerer, rale, urge incontinence, bulimia, yellow sputum, emaciation
Paroxetine (mental depression, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder) agitation, chest congestion, chest pain, chills, cold sweats, confusion, difficulty breathing, dizziness, muscle pain or weakness, skin rash, suicidal thoughts pain chest, drowsiness, orthostasis, dyspnea, agitation, dizziness, feeling suicidal verbal auditory hallucinations, sleeplessness Syncope, hormonal changes, intoxication, sleepy, thinness, numbness thicken
  • ACE = angiotensin-converting enzyme.

  • * Only five out of seven drugs in our evaluation set are listed in this table due to space limitations; the conditions that drugs treat are shown in parentheses following the drug name.

  • The reference standard constructed by the physician is shown in the second column, and new ADEs discovered after 2004 are shown in bold.

  • The associations obtained from our methods were categorized by the expert into four classes shown in the last four columns. New ADEs detected after 2004 based on data of 2004 are shown in bold.

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