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Table 3 The ten drug classes (with their drug substances and ADRs) most frequently 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 classes (number of reports) [(%) three most frequently reported suspected drug substances within the respective drug class]OR with Bonferroni adjusted CI (older adultsvs.younger adults)% three most frequently reported ADRs (number of reports) within the respective drug classOR of reported ADRs with Bonferroni adjusted CI (older adultsvs.younger adults)
1.19.8% (13,831) antithrombotic agents (B01)
[32.0% rivaroxaban, 12.7% phenprocoumon, 11.8% acetylsalicyclic acid]
4.6 [4.3–4.9]a7.6% (1051) gastrointestinal haemorrhage
5.9% (812) cerebral haemorrhage
4.9% (677) haemorrhage
2.3 [1.7–2.9]a
2.3 [1.7–3.1]a
1.3 [1.0–1.7]
2.9.1% (6336) antineoplastic agents (L01)
[7.4% paclitaxel, 6.1% oxaliplatin, 5.6% imatinib]
1.3 [1.2–1.3]a7.3% (463) dyspnea
6.8% (428) diarrhoea
5.9% (375) nausea
1.0 [0.8–1.2]
1.4 [1.1–1.8]a
1.2 [0.9–1.5]
3.6.9% (4831) antiphlogistics and antirheumatics (M01)
[46.6% rofecoxib, 17.1% diclofenac, 9.3% ibuprofen]
1.7 [1.6–1.8]a16.5% (797) hypertension
15.5% (748) cerebral infarction
12.2% (588) death
2.9 [2.3–3.6]a
6.3 [4.6–8.7]a
13.3 [8.0–21.9]a
4.6.4% (4454) systemic antibiotics (J01)
[15.6 levofloxacin, 13.7% ciprofloxacin, 11.4% moxifloxacin]
0.8 [0.8–0.9]a9.1% (406) diarrhea
5.0% (221) nausea
4.9% (218) pruritus
1.2 [0.9–1.4]
0.7 [0.5–0.9]a
0.6 [0.5–0.8]a
5.6.0% (4225) agents acting on the renin-angiotensin system (C09)
[19.5% ramipril, 9.5% enalapril, 7.9% valsartan]
2.2 [2.0–2.4]a8.1% (344) angioedema
8.0% (340) dizziness
5.4% (230) nausea
0.9 [0.6–1.2]
1.1 [0.8–1.4]
1.0 [0.7–1.4]
6.4.7% (3273) psycholanaleptics (N06)
[15.0% mirtazapine, 10.6% venlafaxine, 9.9% rivastigmin]
0.7 [0.7–0.8]a8.5% (279) hyponatraemia
6.7% (218) dizziness
6.6% (217) nausea
6.9 [4.6–10.3]a
1.2 [0.9–1.5]
1.1 [0.9–1.5]
7.4.5% (3138) psycholeptics (N05)
[22.8% risperidone, 11.9% quetiapine, 11.4% olanzapine]
0.4 [0.4–0.5]a6.0% (188) drug interaction
5.1% (161) somnolence
4.0% (125) parkinsonism
1.6 [1.2–2.2]a
2.3 [1.6–3.3]a
1.8 [1.2–2.6]a
8.4.0% (2764) lipid modifying agents (C10)
[33.5% simvastatin, 23.9% atorvastatin, 11.9% fluvastatin]
1.2 [1.1–1.3]a22.7% (628) myalgia
13.4% (370) blood creatine phosphokinase increased
12.9% (356) rhabdomyolysis
0.6 [0.5–0.8]a
0.8 [0.6–1.0]
1.9 [1.4–2.5]a
9.3.9% (2747) antidiabetics (A10)
[19.5% metformin, 17.0% insulin human, 8.5% glibenclamid]
1.5 [1.4–1.7]a21.5% (590) hypoglycaemia
7.2% (198) lactic acidosis
5.9% (161) nausea
2.4 [1.8–3.0]a
2.8 [1.7–4.3]a
0.9 [0.6–1.3]
10.3.7% (2581) analgesics (N02)
[25.2% metamizole, 14.8% fentanyl, 9.0% tramadol]
1.0 [0.9–1.1]10.0% (259) nausea
6.9% (177) vomiting
6.2% (161) agranulocytosis
1.0 [0.7–1.3]
1.3 [0.9–1.8]
1.0 [0.7–1.5]
rankyounger adults(19–65) % most frequently reported drug classes (number of reports) [(%) three most reported frequently suspected drug substances within the respective drug class]OR with Bonferroni adjusted CI (older adultsvs.younger adults)% three most frequently reported ADRs (number of reports) within the respective drug classOR of reported ADRs with Bonferroni adjusted CI (older adultsvs.younger adults)
1.10.0% (11,126) psycholeptics (N05)
[16.8% clozapine, 16.7% risperidone, 15.7% olanzapine]
0.4 [0.4–0.5]a6.0% (670) weight increased
3.8% (426) drug interaction
3.6% (398) leukopenia
0.1 [0.1–0.3]a
1.6 [1.2–2.2]a
0.8 [0.5–1.2]
2.7.5% (8400) systemic antibiotics (J01)
[13.1% moxifloxacin, 11.5% clindamycin, 11.4 ciprofloxacin]
0.8 [0.8–0.9]a8.0% (672) rash
7.9% (667) diarrhoea
7.9% (667) pruritus
0.6 [0.4–0.8]a
1.2 [0.9–1.4]
0.6 [0.5–0.8]a
3.7.4% (8225) antineoplastic agents (L01)
[11.6% paclitaxel, 6.5% docetaxel, 6.5% oxaliplatin]
1.3 [1.2–1.3]a7.3% (601) dyspnea
5.4% (441) pyrexia
5.1% (416) nausea
1.0 [0.8–1.2]
1.0 [0.8–1.3]
1.2 [0.9–1.5]
4.6.4% (7188) psychoanaleptics (N06)
[15.6% venlafaxine, 12.4% mirtazapine, 9.8% duloxetine]
0.7 [0.7–0.8]a5.9% (423) nausea
5.8% (417) dizziness
4.8% (344) drug interaction
1.1 [0.9–1.5]
1.2 [0.9–1.5]
1.2 [0.9–1.7]
5.5.1% (5689) immunostimulants (L03)
[25.0% interferon, 22.4% glatiramer, 21.9% interferon beta-1a]
0.1 [0.1–0.1]a18.0% (1022) multiple sclerosis relapse
4.7% (266) pyrexia
4.6% (260) dyspnoea
0.1 [0.0–0.3]a
1.8 [1.0–3.4]
0.7 [0.3–1.8]
6.5.1% (5676) antithrombotic agents (B01)
[20.6% rivaroxaban, 13.5% phenprocoumon, 9.9% enoxaparin]
4.6 [4.3–4.9]a6.5% (367) thrombocytopenia
6.3% (358) pulmonary embolism
3.7% (211) haemorrhage
0.7 [0.5–0.8]a
0.4 [0.3–0.5]a
1.3 [1.0–1.7]
7.4.9% (5515) immunosupressivs (L04)
[28.7% etanercept, 15.6% fingolimod, 13.1% ciclosporin]
0.6 [0.5–0.6]a4.4% (243) multiple sclerosis relapse
3.4% (189) diarrhoea
3.4% (186) nausea
0.0 [0.0–0.2]a
0.8 [0.5–1.4]
0.8 [0.5–1.4]
8.4.8% (5323) sex hormones (G03)
[12.9% dienogest/ethyinylestradiol, 11.6% drospirenone/ethinylestradiol, 7.5% ethinylestradiol/levonorgestrel]
0.1 [0.1–0.1]a11.1% (590) pulmonary embolism
8.2% (438) deep vein thrombosis
5.2% (279) unintended pregnancy
0.5 [0.3–1.1]
0.4 [0.2–1.1]
-
9.4.7% (5228) antiepileptics (N03)
[16.5% carbamazepine, 15.6% levetiracetam, 15.3% pregabalin]
0.6 [0.5–0.6]a7.5% (392) seizure
5.1% (266) dizziness
4.9% (257) hyponatriaemia
0.6 [0.4–0.9]a
1.7 [1.2–2.4]a
1.3 [0.9–1.8]
10.4.3% (4740) antiphlogistics and antirheumatics (M01)
[22.6% rofecoxib, 19.2% diclofenac, 18.4% ibuprofen]
1.7 [1.6–1.8]a6.5% (306) hypertension
6.1% (287) nausea
5.7% (269) dizziness
2.9 [2.3–3.6]a
0.7 [0.5–1.0]
0.7 [0.5–0.9]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 3 shows the relative and absolute numbers of ADR reports for the ten drug classes reported most frequently as suspected in older adults (> 65) and younger adults (19–65), with their three most frequently suspected drug substances in relative numbers, and the three most frequently reported ADRs within the respective drug class in relative and absolute numbers. For the analysis of the drug classes the second level, and for the analysis of 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 and classes as suspected (hence, multiple assignment of one report to more than one drug class is possible) and inform about several ADRs. Therefore, the number of drug substances and ADRs exceeds the number of ADR reports. The table presents the most frequently reported ADRs within the respective drug class independent of the applied drug substance. Hence, the three most frequently reported ADRs related to the respective drug class may not necessarily be identical to the three most often reported drug substances of the respective drug class. Different drug substances belonging to the same respective drug class may account for the discrepancies in ADRs between older adults and younger adults. For example, “thrombocytopenia” as the ADR most often reported in younger adults for the drug class antithrombotics was due to heparin administration in 44.9% of the “thrombocytopenia” cases. Likewise, “pulmonary embolism” was due to certoparin administration in 29.6% of the “pulmonary embolism” cases in younger adults. However, rivaroxaban accounted for only 3.3% of these “thrombocytopenia” cases and 15.9% of these “pulmonary embolism” cases although it was the drug substance suspected most often for younger adults among the drug class of antithrombotics. In older adults rivaroxaban was also the most frequently reported drug substance in the drug class of antithrombotics and accounted for 26.9% of all “gastrointestinal haemorrhage” cases, and was the most reported drug substance in “cerebral haemorrhage”, and “haemorrhage” cases