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Table 2 Number of reports and the reporting odds ratio for gingival hyperplasia by drugs

From: Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases

Drug

 

Total

Suspected Druga, b

  

Total

Case

ROR

(95% CI)

Total

Case

ROR

(95% CI)

FAERS

 

4,551,642

628

      

 Immunosuppressants

         

  Cyclosporine

 

20,578

66

25.9

(20.1–33.5)

12,693

62

39.4

(30.3–51.2)

  Everolimus

 

9292

6

4.7

(2.1–10.5)

8756

5

4.2

(1.7–10.0)

  Sirolimus

 

5607

5

6.5

(2.7–15.7)

4415

4

6.6

(2.5–17.7)

  Mycophenolate mofetil

 

20,212

30

11.3

(7.8–16.3)

6213

11

13.1

(7.2–23.2)

 Calcium Channel Blockers

         

  Amlodipine

 

96,153

195

20.9

(17.7–24.8)

18,509

174

94.8

(80.0–112.9)

  Benidipine

 

423

0

29

0

  Nicardipine

 

1838

1

c

 

674

1

c

 

  Nifedipine

 

18,542

23

9.3

(6.1–14.1)

2202

17

57.9

(35.7–94.0)

 Anticonvulsants

         

  Carbamazepine

 

24,644

31

9.6

(6.7–13.7)

13,494

27

15.1

(10.3–22.3)

  Clobazam

 

3155

11

25.8

(14.2–46.9)

1020

9

65.4

(33.8–126.7)

  Diazepam

 

36,751

9

1.8

(0.9–3.5)

11,581

3

1.9

(0.6–5.9)

  Gabapentin

 

71,069

11

1.1

(0.6–2.0)

17,372

2

0.8

(0.2–3.3)

  Levetiracetam

 

2630

14

39.6

(23.3–67.4)

12,437

11

6.5

(3.6–11.8)

  Phenobarbital

 

7717

18

17.4

(10.9–27.8)

2235

6

19.7

(8.8–44.0)

  Phenytoin

 

20,522

95

39.5

(31.8–49.2)

10,865

85

65.4

(52.4–82.9)

  Primidone

 

2644

10

27.9

(14.9–52.3)

520

4

56.5

(21.1–151.7)

  Topiramate

 

23,635

7

2.2

(1.0–4.6)

10,066

4

2.9

(1.1–7.7)

  Valproic acid

 

34,487

43

9.6

(7.1–13.1)

16,258

37

17.5

(12.6–24.4)

  Zonisamide

 

4138

4

7.1

(2.6–18.9)

1916

2

1.3

(0.7–2.5)

JADER

 

430,587

80

      

 Immunosuppressants

         

  Cyclosporine

 

8890

14

10.1

(5.7–17.9)

5711

14

15.8

(8.9–28.2)

  Mycophenolate mofetil

 

5320

3

3.1

(1.0–9.9)

3060

1

c

 

 Calcium Channel Blockers

         

  Amlodipine

 

30,451

18

3.8

(2.3–6.5)

3025

18

41.3

(24.4–69.8)

  Benidipine

 

3655

1

c

 

310

1

c

 

  Nicardipine

 

1755

5

16.3

(6.6–40.4)

302

5

96.6

(38.8–240.5)

  Nifedipine

 

10,350

8

4.5

(2.2–9.4)

954

6

36.7

(15.9–84.6)

 Anticonvulsants

         

  Carbamazepine

 

7411

18

16.6

(9.8–28.1)

5068

16

21.1

(12.2–36.4)

  Clobazam

 

898

11

77.2

(40.7–146.4)

239

10

268.4

(136.6–527.3)

  Diazepam

 

3831

10

16.0

(8.2–31.0)

733

6

47.9

(20.8–110.5)

  Gabapentin

 

1222

2

9.0

(2.2–36.8)

404

1

c

 

  Levetiracetam

 

1801

6

19.4

(8.4–44.6)

1177

5

24.4

(9.9–60.5)

  Phenobarbital

 

2622

12

28.9

(15.6–53.5)

1027

9

53.5

(26.7–107.3)

  Phenytoin

 

3712

27

59.0

(37.1–93.9)

1667

22

98.9

(60.4–161.9)

  Primidone

 

100

4

236.0

(84.7–657.8)

25

4

1078.9

(361.8–3217.5)

  Topiramate

 

536

1

c

 

258

1

c

 

  Valproic acid

 

8185

26

24.9

(15.6–39.8)

2618

20

54.9

(33.0–91.2)

  Zonisamide

 

2492

12

30.5

(16.5–56.3)

1073

8

44.8

(21.5–93.2)

  1. a For FAERS, “Primary Suspect Drug” and “Secondary Suspect Drug” were analyzed
  2. b For JADER, “Higiyaku” was analyzed
  3. c Number of cases <2