Table 4 The signal strength of reports of Tafamidis at the SOC level in the FAERS database

General disorders and administration site conditions

5430

1.53 (1.48–1.58)

1.40 (753.13)

0.49 (−1.18)

1.40 (1.36)

Cardiac disorders

2636

6.81 (6.54–7.09)

6.11 (11431.30)

2.60 (0.94)

6.08 (5.88)

Injury, poisoning and procedural complications

2481

0.93 (0.89–0.97)

0.93 (13.19)

−0.10 (−1.76)

0.93 (0.90)

Nervous system disorders

1861

1.17 (1.11–1.23)

1.15 (41.30)

0.21 (−1.46)

1.15 (1.11)

Investigations

1236

0.95 (0.90–1.01)

0.96 (2.63)

−0.06 (−1.73)

0.96 (0.91)

Respiratory, thoracic and mediastinal disorders

1234

1.25 (1.18–1.33)

1.24 (59.81)

0.31 (−1.36)

1.24 (1.18)

Gastrointestinal disorders

1164

0.65 (0.62–0.69)

0.67 (203.80)

−0.58 (−2.24)

0.67 (0.64)

Infections and infestations

858

0.68 (0.64–0.73)

0.70 (120.14)

−0.52 (−2.19)

0.70 (0.66)

Musculoskeletal and connective tissue disorders

768

0.67 (0.62–0.72)

0.68 (123.94)

−0.56 (−2.23)

0.68 (0.64)

Metabolism and nutrition disorders

618

1.47 (1.35–1.59)

1.45 (89.38)

0.54 (−1.13)

1.45 (1.36)

Psychiatric disorders

527

0.43 (0.39–0.47)

0.44 (394.17)

−1.18 (−2.85)

0.44 (0.41)

Renal and urinary disorders

487

1.08 (0.99–1.19)

1.08 (3.08)

0.11 (−1.55)

1.08 (1.00)

Vascular disorders

448

1.09 (0.99–1.20)

1.09 (3.15)

0.12 (−1.55)

1.09 (1.00)

Skin and subcutaneous tissue disorders

412

0.31 (0.28–0.34)

0.32 (631.79)

−1.64 (−3.31)

0.32 (0.30)

Ear and labyrinth disorders

402

4.50 (4.08–4.97)

4.44 (1070.41)

2.15 (0.48)

4.42 (4.07)

Surgical and medical procedures

390

1.25 (1.13–1.38)

1.25 (19.11)

0.32 (−1.35)

1.25 (1.15)

Eye disorders

237

0.56 (0.50–0.64)

0.57 (79.18)

−0.81 (−2.48)

0.57 (0.51)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

198

0.22 (0.19–0.26)

0.23 (528.88)

−2.12 (−3.78)

0.23 (0.21)

Immune system disorders

150

0.57 (0.48–0.67)

0.57 (49.41)

−0.81 (−2.48)

0.57 (0.50)

Hepatobiliary disorders

111

0.62 (0.51–0.74)

0.62 (26.19)

−0.69 (−2.36)

0.62 (0.53)

Blood and lymphatic system disorders

108

0.29 (0.24–0.35)

0.29 (191.64)

−1.79 (−3.45)

0.29 (0.25)

Social circumstances

107

1.04 (0.86–1.26)

1.04 (0.20)

0.06 (−1.60)

1.04 (0.89)

Reproductive system and breast disorders

68

0.48 (0.38–0.60)

0.48 (38.92)

−1.06 (−2.73)

0.48 (0.39)

Congenital, familial and genetic disorders

50

0.81 (0.62–1.07)

0.81 (2.13)

−0.30 (−1.96)

0.81 (0.65)

Product issues

44

0.11 (0.08–0.15)

0.11 (320.04)

−3.17 (−4.84)

0.11 (0.09)

Endocrine disorders

43

0.73 (0.54–0.98)

0.73 (4.30)

−0.45 (−2.12)

0.73 (0.57)

Pregnancy, puerperium and perinatal conditions

2

0.03 (0.01–0.10)

0.03 (73.68)

−5.27 (−6.94)

0.03 (0.01)