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Table. 4.

Table. 4.

Detected signals for finasteride by data mining and existence of the information on the drug label in Korea

SOC Adverse events No. PRR ROR IC 95% LCI Drug label (MFDS) Drug label (FDA)
Urinary system disorders (1300) Dysuria 11 3.64 3.66 1.99 N N
Micturition disorder 9 5.37 5.39 2.57 N N
Micturition frequency 8 4.39 4.41 2.30 N N
Urinary retention 4 5.14 5.15 2.68 N N
Haematuria 4 2.95 2.95 1.88 N N
Nocturia 4 8.56 8.58 3.41 N N
Detrusor muscle weakness 3 4.01 4.02 2.42 N N
Reproductive disorders, male (1410) Male sexual dysfunction 63 129.05 134.97 6.94 Y Y
Ejaculation failure 11 45.67 46.01 5.60 N N
Prostatic hyperplasia 9 14.32 14.41 3.98 N N
Ejaculation disorder 8 41.17 41.40 5.50 Y Y
Semen abnormal 4 257.68 258.40 8.10 Y Y
Testicular pain 4 373.63 374.68 8.55 Y Y
Psychiatric disorders (0500) Libido decreased 23 260.41 264.66 7.89 Y Y
Depression 12 7.06 7.11 2.93 Y Y
Listless 5 4.10 4.11 2.29 N N
Emotional disorder 3 17.09 17.12 4.49 Y N
Autonomic nervous system disorders (0420) Mouth dry 53 4.41 4.54 2.16 N N
Hypotension 24 2.30 2.32 1.26 N N
Hypotension postural 18 22.98 23.27 4.58 Y Y
Body as a whole- general disorders (1810) Medicine ineffective 19 8.20 8.30 3.10 N N
Breast pain 5 15.44 15.49 4.20 Y Y
Therapeutic response decreased 4 24.74 24.81 4.93 N N
Metabolic and nutritional disorders (0800) Hyperglycaemia 8 2.13 2.14 1.26 N N
Thirst 4 3.39 3.40 2.08 N N
Neoplasms (1700) GI neoplasm benign 5 10.66 10.70 3.67 N N
Neoplasm malignant 4 6.93 6.94 3.11 Y Y
Skin and appendages disorders (0100) Hypertrichosis 5 32.21 32.32 5.24 N N
Eczema 3 6.67 6.68 3.15 N N
Application site disorders (1820) Medical device complication 4 8.42 8.44 3.39 N N
Cellulitis 3 3.70 3.71 2.30 N N
Reproductive disorders, female (1420) Breast enlargement female 3 36.87 36.95 5.58 N N
Female sexual dysfunction 3 45.94 46.03 5.89 N N
Endocrine disorders (0900) Gynaecomastia 13 45.65 46.06 5.58 Y Y
Respiratory system disorders (1100) Sputum disorder 6 2.48 2.49 1.53 N N
Liver and biliary system disorders (0700) Hepatitis 5 7.74 7.76 3.21 N N
Musculo-skeletal system disorders (0200) Muscle weakness 5 3.57 3.58 2.09 Y Y
Platelet, bleeding & clotting disorders (1230) Thrombosis cerebral 4 622.72 624.47 9.10 N N
Hearing and vestibular disorders (0432) Tinnitus 4 3.16 3.16 1.98 N N
Secondary terms – events (2000) Medication error 20 11.84 12.00 3.63 N N
Surgical intervention 4 5.02 5.03 2.64 N N
Accident drug intake by child 3 622.72 624.03 9.17 Y Y

SOC, system-organ class; PRR, Proportional Reporting Ratio; ROR, Reporting Odds Ratio; IC 95% LCI, Information Component lower limit of 95% confidence interval; Y, the AE which was listed on drug labels; N, the AE which was not listed on drug labels.

Korean J Clin Pharm 2021;31:324-31 https://doi.org/10.24304/kjcp.2021.31.4.324
© 2021 Korean J Clin Pharm