TABLE 1.

Organs or systems affected by unknown adverse drug reactions (ADRs).

System organ class	n	%
Skin and subcutaneous tissue disorders	34	11.5
Hepatobiliary disorders	28	9.5
Cardiac disorders	28	9.5
Nervous system disorders	27	9.2
Blood and lymphatic system disorders	17	5.8
Pregnancy, puerperium and perinatal condition	17	5.8
Gastrointestinal disorders	16	5.4
Vascular disorders	16	5.4
Congenital, familial and genetic disorders	15	5.1
Respiratory, thoracic and mediastinal disorders	14	4.7
General disorders and administration site conditions	13	4.4
Musculoskeletal and connective tissue disorders	13	4.4
Infections and infestation	12	4.1
Psychiatric disorder	8	2.7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	6	2
Ear and labyrinth disorders	5	1.7
Eye disorders	5	1.7
Metabolism and nutrition disorder	5	1.7
Renal and urinary disorders	5	1.7
Immune system disorders	4	1.4
Investigations	3	1
Reproductive system and breast disorders	2	0.7
Endocrine disorders	1	0.3
Injury, poisoning and procedural complications	1	0.3
Total	295	100