Adverse drug reactions in older patients: an Italian observational prospective hospital study

Figures & data

Table 1 Patients and length of hospitalization, subdivided according to ADR appearance and sex

	All (n = 1023)	Women (n = 520)	Men (n = 503)
Patients without ADR (% [95% CI])	65.4 (60.9–66.7)	63.1 (58.9–67.2)	67.8 (63.7–71.9)
Days of hospital stay, mean (95% CI)	12.6 (11.9–13.3)	12.6 (11.5–13.7)	12.6 (11.6–13.6)
Patients with ADR as cause of hospitalization (% [95% CI])	11.1 (9.2–13.0)	12.1 (9.3–14.9)	10.1 (7.5–12.8)
Days of hospital stay, mean (95% CI)	13.6 (11.9–15.3)	15.2 (12.6–17.8)	11.5 (9.6–13.4)
Patients with ADR during hospitalization (% [95% CI])	25.0 (22.4–27.7)	27.1 (23.3–30.9)	22.9 (19.2–26.5)
Days of hospital stay, mean (95% CI)	18.7 (17.2–20.1)	18.7 (16.8–20.6)	18.7 (16.5–20.9)

Abbreviations: ADR, adverse drug reaction; CI, confidence interval; n, number.

Table 2 ADRs causing hospital admission, grouped to the System Organ Classification of WHO-ART, and related drugs

ADRs	Drug classes*
Metabolic and nutritional disorders (41)
Hyponatremia (21)	Potassium-sparing diuretics (13); antiulcer drugs (8); ACE inhibitors (3); antidepressants (3); diuretics (3); angiotensin-2 receptor antagonists (2)
Hypokalemia (9)	Diuretics (5); ACE inhibitors (2)
Hyperkalemia (8)	ACE inhibitors (6); potassium-sparing diuretics (4)
Hypoglycemia (4)	Hypoglycemic agents (4)
Dehydration (4)	Diuretics (3)
Red blood cell disorders (16)
Anemia (14)	Antithrombotic agents (6); analgesics and antipyretics (5); antitumorals (4); corticosteroids (2)
Body as a whole/general disorders (16)
Syncope (9)	ACE inhibitors (4); diuretics (2); beta-blockers (2); calcium channel blockers (2)
Gastrointestinal system disorders (15)
Diarrhea (5)	Antibacterials (5)
Vomiting (3)	Antibacterials (2)
Platelet, bleeding and clotting disorders (12)
INR increase (10)	Antithrombotic agents (10)
Urinary system disorders (11)
Renal failure (6)	Antibacterials (5); ACE inhibitors (3); potassium-sparing diuretics (2)
Psychiatric disorders (10)
Confusion (5)	Antidepressants (2); antipsychotics (2)

Notes: Groups of ADRs that occurred in at least 10 patients are shown.

* Drug classes suspected in at least two patients are listed. Figures in parentheses indicate the number of patients.

Abbreviations: ACE, angiotensin converting enzyme; ADRs, adverse drug reactions; INR, international normalized ratio; WHO-ART, World Health Organization Adverse Reaction Terminology.

Table 3 ADRs during hospital stay, grouped according to the System Organ Classification of WHO-ART, and related drugs

ADRs	Drug classes*
Metabolic and nutritional disorders (110)
Hypokalemia (75)	Diuretics (73); antithrombotic agents (8); Potassium-sparing diuretics (3); cardiac glycosides (3)
Hyponatremia (17)	Potassium-sparing diuretics (12); diuretics (6); antiulcer agents (4)
Hyperglycemia (13)	Corticosteroids (13)
Hyperkalemia (12)	Potassium-sparing diuretics (8); corticosteroids (2); antiulcer agents (2); antithrombotic agents (2); angiotensin-2 receptor antagonists (2)
Gastrointestinal system disorders (34)
Diarrhea (15)	Antibacterials (14); antithrombotic agents (2)
Constipation (10)	Analgesics and antipyretics (6); opioids (4)
Platelet, bleeding and clotting disorders (31)
INR increase (15)	Antithrombotic agents (15); diuretics (3)
Thrombocytopenia (13)	Antithrombotic agents (13); diuretics (2)
Skin and appendages disorders (31)
Rash erythematosus (15)	Antibacterials (14); antithrombotic agents (2); diuretics (2)
Urticaria (5)	Antibacterials (2)
Hyperhidrosis (2)	Opioids (2)
Application site disorders (20)
Hematoma at the injection site (18)	Antithrombotic agents (17); analgesic/antipyretics (2); NSAIDs (2)
Red blood cell disorders (19)
Anemia (19)	Antithrombotic agents (17); analgesics and antipyretics (8); diuretics (3)

Notes: Groups of ADRs that occurred in at least 10 patients are shown.

* Drug classes suspected in at least 2 patients are listed. Figures in parentheses indicate the number of patients.

Abbreviations: ADRs, adverse drug reactions; INR, international normalized ratio; NSAIDs, nonsteroidal anti-inflammatory drugs; WHO-ART, World Health Organization Adverse Reaction Terminology.