Table 4 The ten drug substances (with their ADRs) most frequently reported as suspected in older adults and younger adults

Rank

older adults(>  65)

% most frequently reported drug substances (number of reports)

OR with Bonferroni adjusted CI (older adultsvs.younger adults)

% three most frequently reported ADRs (number of reports)

OR of reported ADRs with Bonferroni adjusted CI (older adultsvs.younger adults)

1.

6.3% (4425) rivaroxaban

6.4 [5.7–7.0]^a

7.8% (346) epistaxis

2.2 [1.3–3.9]^a

6.9% (307) cerebral haemorrhage

3.6 [1.7–7.3]^a

5.8% (257) haemoglobin decreased

1.5 [0.9–2.6]

2.

3.2% (2253) rofecoxib

3.4 [3.1–3.8]^a

32.8% (739) cerebral infarction

3.6 [2.6–5.2]^a

32.0% (721) hypertension

1.7 [1.3–2.3]^a

25.3% (571) death

8.5 [4.9–14.9]^a

3.

2.5% (1763) acetylsalicylic acid

3.9 [3.4–4.4]^a

18.3% (323) gastrointestinal haemorrhage

1.4 [0.9–2.2]

12.4% (218) melaena

1.0 [0.7–1.6]

9.4% (165) gastric ulcer haemorrhage

1.2 [0.7–2.1]

4.

2.5% (1762) phenprocoumon

3.7 [3.3–4.3]^a

13.3% (235) gastrointestinal haemorrhage

1.9 [1.1–3.2]^a

9.0% (158) drug interaction

1.4 [0.8–2.4]

8.9% (157) prothrombin time prolonged

0.8 [0.5–1.3]

5.

2.3% (1635) apixaban

9.1 [7.5–11.0]^a

7.6% (125) cerebral haemorrhage

2.3 [0.8–7.2]

7.3% (120) haemorrhage

2.0 [0.7–5.9]

6.6% (108) off label use

1.4 [0.5–3.7]

6.

2.0% (1427) dabigatran

10.6 [8.5–13.3]^a

10.3% (147) gastrointestinal haemorrhage

2.0 [0.7–5.5]

7.9% (113) cerebrovascular accident

0.7 [0.3–1.5]

6.9% (99) haemorrhage

1.0 [0.4–2.6]

7.

1.6% (1118) diclofenac

1.6 [1.4–1.8]^a

10.0% (112) gastrointestinal haemorrhage

3.0 [1.6–5.6]^a

6.9% (77) pruritus

0.6 [0.4–1.0]

6.5% (73) nausea

0.9 [0.5–1.6]

8.

1.5% (1067) zoledronic acid

2.0 [1.8–2.3]^a

47.8% (510) osteonecrosis of jaw

1.0 [0.8–1.4]

11.1% (118) osteonecrosis

0.7 [0.4–1.1]

9.7% (104) tooth extraction

0.7 [0.4–1.1]

9.

1.4% (956) clopidogrel

3.9 [3.2–4.6]^a

12.0% (115) gastrointestinal haemorrhage

2.1 [1.0–4.7]

6.5% (62) thrombocytopenia

0.9 [0.4–1.8]

5.0% (48) anaemia

1.2 [0.5–3.1]

5.0% (48) melaena

0.9 [0.4–2.1]

10.

1.3% (925) simvastatin

1.6 [1.4–1.9]^a

19.7% (182) myalgia

0.4 [0.3–0.6]^a

18.8% (174) rhabdomyolysis

1.8 [1.2–2.8]^a

15.5% (143) blood creatine phosphokinase increased

0.8 [0.5–1.1]

rank

younger adults(19–65) % most frequently reported drug substances (number of reports)

OR with Bonferroni adjusted CI (older adultsvs.younger adults)

% three most frequently reported ADRs (number of reports)

OR of reported ADRs with Bonferroni adjusted CI (older adultsvs.younger adults)

1.

2.9% (3232) levonorgestrel

0

14.0% (451) uterine perforation

–

13.7% (444) device dislocation

–

12.2% (395) pregnancy with contraceptive device

–

2.

1.7% (1868) clozapine

0.2 [0.1–0.2]^a

10.9% (204) pyrexia

1.6 [0.8–3.1]

10.1% (189) leukopenia

1.4 [0.7–2.8]

8.1% (152) c-reactive protein increased

0.8 [0.3–2.1]

3.

1.7% (1856) risperidone

0.6 [0.5–0.7]^a

7.0% (129) weight increased

0.2 [0.1–0.5]^a

6.6% (122) galactorrhoea

0.0 [0.0–0.6]^a

6.0% (111) akathisia

0.3 [0.1–0.8]^a

4.

1.6% (1749) olanzapin

0.3 [0.3–0.4]^a

15.6% (273) weight increased

0.1 [0.0–0.4]^a

5.3% (93) blood creatine phosphokinase increased

0.7 [0.2–1.8]

5.0% (87) alanine aminotransferase increased

0.1 [0.0–1.6]

5.

1.4% (1585) etanercept

0.7 [0.6–0.8]^a

7.4% (118) condition aggravated

0.9 [0.5–1.6]

6.5% (103) rheumatoide arthritis

1.6 [0.9–2.7]

4.9% (78) drug ineffective

0.8 [0.4–1.7]

6.

1.3% (1420) interferon

0.1 [0.1–0.1]^a

20.8% (295) multiple sclerosis relapse

0.1 [0.0–0.9]^a

4.4% (63) pyrexia

1.0 [0.2–5.7]

3.8% (54) headache

0.3 [0.0–8.3]

7.

1.1% (1272) glatiramer

0.02 [0.01–0.04]^a

23.0% (293) multiple sclerosis relapse

0.3 [0.0–9.1]

11.2% (142) dyspnea

–

7.1% (90) injection site necrosis

1.1 [0.0–36.1]

8.

1.1% (1258) quetiapine

0.5 [0.4–0.6]^a

7.7% (97) drug interaction

1.3 [0.6–2.5]

7.7% (97) weight increased

0.1 [0.0–0.7]^a

6.0% (76) leukopenia

0.5 [0.2–1.4]

9.

1.1% (1243) interferon beta-1a

0.03 [0.02–0.06]^a

19.4% (241) multiple sclerosis relapse

0.5 [0.1–4.3]

8.4% (104) influenza like illness

0.4 [0.0–13.5]

4.8% (60) alanine aminotransferase increased

1.6 [0.1–20.0]

10.

1.1% (1173) rivaroxaban

6.4 [5.7–7.0]^a

8.7% (102) menorrhagia

0.0 [0.0–0.1]^a

5.5% (65) deep vein thrombosis

0.3 [0.2–0.5]^a

5.1% (60) pulmonary embolism

0.4 [0.2–0.6]^a