Table 2.

Frequency of ADR symptoms based on the involvement of organ system at an AMC in Central India

System organ class	ADR symptoms n (%) 1980 (100)	Most common ADRs (n)
Skin and subcutaneous tissue disorder	548 (28)	Rash (231), generalised pruritus (113), fixed drug eruption (64), burning sensation (19)
Gastrointestinal disorders	365 (18)	Vomiting (91), nausea (87), abdominal discomfort (71), diarrhoea (52)
Nervous system disorder	219 (11)	Dizziness (61), headache (50), paraesthesia (17), peripheral neuropathy (12)
General disorders	193 (10)	Multi-drug resistance (35), Shivering (33), Generalised oedema (21), Weakness generalised (18)
Psychiatric disorder	129 (7)	Anxiety (33), sedation (24), drowsiness (17), psychosis (9)
Musculoskeletal and connective tissue disorders	82 (4)	Myalgia (29), tremors (17), joint pain (7)
Respiratory disorder	64 (3.2)	Cough (18), breathing difficulty (16), dyspnoea (14)
Blood and lymphatic system disorder	60 (3)	Anaemia (47), thrombocytopaenia (6)
Cardiac disorder	45 (2)	Tachycardia (19), chest pain (16), bradycardia (5)
Hepatobiliary disorder	41 (2)	Hepatotoxicity (39)
Nutritional and metabolic disorder	40 (2)	Loss of appetite (28), pallor (3), weight gain (3)
Ear disorder	31 (2)	Impaired hearing (14), tinnitus (8), vertigo (8)
Vascular disorder	31 (2)	Hypotension (16), epistaxis (4), hypertension (3)
Eye disorder	26 (1)	Impaired vision (16), eye irritation (2), lacrimation (2)
Injury, poisoning and procedural complications	25 (1)	Injection site reaction (12), extravasation (6)
Renal disorder	25 (1)	Increased serum creatinine (6), haematuria (4), dysuria (3)
Endocrine disorders	23 (1)	Gynaecomastia (8), moon face (5), hypoglycaemia (3)
Immune system disorder	19 (1)	Allergic dermatitis (8), allergic reactions (4), anaphylactic reaction (4)
Electrolyte imbalance	7 (0.35)	Hypokalemia (2), hypocalcaemia (1), hyperuricaemia (2)
Reproductive and breast disorder	7 (0.35)	Vaginal haemorrhage (2), breast tenderness (1)

ADR, adverse drug reaction; AMC, ADR monitoring centre.;