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

From: Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices

Rankolder 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) rivaroxaban6.4 [5.7–7.0]a7.8% (346) epistaxis2.2 [1.3–3.9]a
6.9% (307) cerebral haemorrhage3.6 [1.7–7.3]a
5.8% (257) haemoglobin decreased1.5 [0.9–2.6]
2.3.2% (2253) rofecoxib3.4 [3.1–3.8]a32.8% (739) cerebral infarction3.6 [2.6–5.2]a
32.0% (721) hypertension1.7 [1.3–2.3]a
25.3% (571) death8.5 [4.9–14.9]a
3.2.5% (1763) acetylsalicylic acid3.9 [3.4–4.4]a18.3% (323) gastrointestinal haemorrhage1.4 [0.9–2.2]
12.4% (218) melaena1.0 [0.7–1.6]
9.4% (165) gastric ulcer haemorrhage1.2 [0.7–2.1]
4.2.5% (1762) phenprocoumon3.7 [3.3–4.3]a13.3% (235) gastrointestinal haemorrhage1.9 [1.1–3.2]a
9.0% (158) drug interaction1.4 [0.8–2.4]
8.9% (157) prothrombin time prolonged0.8 [0.5–1.3]
5.2.3% (1635) apixaban9.1 [7.5–11.0]a7.6% (125) cerebral haemorrhage2.3 [0.8–7.2]
7.3% (120) haemorrhage2.0 [0.7–5.9]
6.6% (108) off label use1.4 [0.5–3.7]
6.2.0% (1427) dabigatran10.6 [8.5–13.3]a10.3% (147) gastrointestinal haemorrhage2.0 [0.7–5.5]
7.9% (113) cerebrovascular accident0.7 [0.3–1.5]
6.9% (99) haemorrhage1.0 [0.4–2.6]
7.1.6% (1118) diclofenac1.6 [1.4–1.8]a10.0% (112) gastrointestinal haemorrhage3.0 [1.6–5.6]a
6.9% (77) pruritus0.6 [0.4–1.0]
6.5% (73) nausea0.9 [0.5–1.6]
8.1.5% (1067) zoledronic acid2.0 [1.8–2.3]a47.8% (510) osteonecrosis of jaw1.0 [0.8–1.4]
11.1% (118) osteonecrosis0.7 [0.4–1.1]
9.7% (104) tooth extraction0.7 [0.4–1.1]
9.1.4% (956) clopidogrel3.9 [3.2–4.6]a12.0% (115) gastrointestinal haemorrhage2.1 [1.0–4.7]
6.5% (62) thrombocytopenia0.9 [0.4–1.8]
5.0% (48) anaemia1.2 [0.5–3.1]
5.0% (48) melaena0.9 [0.4–2.1]
10.1.3% (925) simvastatin1.6 [1.4–1.9]a19.7% (182) myalgia0.4 [0.3–0.6]a
18.8% (174) rhabdomyolysis1.8 [1.2–2.8]a
15.5% (143) blood creatine phosphokinase increased0.8 [0.5–1.1]
rankyounger 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) levonorgestrel014.0% (451) uterine perforation
13.7% (444) device dislocation
12.2% (395) pregnancy with contraceptive device
2.1.7% (1868) clozapine0.2 [0.1–0.2]a10.9% (204) pyrexia1.6 [0.8–3.1]
10.1% (189) leukopenia1.4 [0.7–2.8]
8.1% (152) c-reactive protein increased0.8 [0.3–2.1]
3.1.7% (1856) risperidone0.6 [0.5–0.7]a7.0% (129) weight increased0.2 [0.1–0.5]a
6.6% (122) galactorrhoea0.0 [0.0–0.6]a
6.0% (111) akathisia0.3 [0.1–0.8]a
4.1.6% (1749) olanzapin0.3 [0.3–0.4]a15.6% (273) weight increased0.1 [0.0–0.4]a
5.3% (93) blood creatine phosphokinase increased0.7 [0.2–1.8]
5.0% (87) alanine aminotransferase increased0.1 [0.0–1.6]
5.1.4% (1585) etanercept0.7 [0.6–0.8]a7.4% (118) condition aggravated0.9 [0.5–1.6]
6.5% (103) rheumatoide arthritis1.6 [0.9–2.7]
4.9% (78) drug ineffective0.8 [0.4–1.7]
6.1.3% (1420) interferon0.1 [0.1–0.1]a20.8% (295) multiple sclerosis relapse0.1 [0.0–0.9]a
4.4% (63) pyrexia1.0 [0.2–5.7]
3.8% (54) headache0.3 [0.0–8.3]
7.1.1% (1272) glatiramer0.02 [0.01–0.04]a23.0% (293) multiple sclerosis relapse0.3 [0.0–9.1]
11.2% (142) dyspnea
7.1% (90) injection site necrosis1.1 [0.0–36.1]
8.1.1% (1258) quetiapine0.5 [0.4–0.6]a7.7% (97) drug interaction1.3 [0.6–2.5]
7.7% (97) weight increased0.1 [0.0–0.7]a
6.0% (76) leukopenia0.5 [0.2–1.4]
9.1.1% (1243) interferon beta-1a0.03 [0.02–0.06]a19.4% (241) multiple sclerosis relapse0.5 [0.1–4.3]
8.4% (104) influenza like illness0.4 [0.0–13.5]
4.8% (60) alanine aminotransferase increased1.6 [0.1–20.0]
10.1.1% (1173) rivaroxaban6.4 [5.7–7.0]a8.7% (102) menorrhagia0.0 [0.0–0.1]a
5.5% (65) deep vein thrombosis0.3 [0.2–0.5]a
5.1% (60) pulmonary embolism0.4 [0.2–0.6]a
  1. aOR = 1 is not included; OR > 1 reported more often in older adults; OR < 1 reported more often in younger adults
  2. Table 4 shows the relative and absolute numbers of ADR reports of the ten drug substances most frequently reported as suspected in older adults (> 65) and younger adults (19–65) with their relative and absolute numbers of the three most frequently reported ADRs. For the drug substances the fifth level of the ATC-code was applied [24]. For the analysis of ADRs reported most frequently the PT-level of the MedDRA terminology [25] was used. One ADR report can contain several drug substances as suspected and inform about several ADRs. Therefore, the number of drug substances and ADRs exceeds the number of ADR reports. Since we did not perform an individual case assessment for all ADR reports (e.g. with regard to the causal association with the drug intake), it cannot be excluded that the most frequently reported ADRs may also stand in a causal relation to other drug substances that were also reported as suspected within the ADR report. However, one may assume that the three most frequently reported ADRs are more likely to be causally related to the listed drug substance since they are reported so often