System Organ Class

Adverse drug reaction (s)

N

Blood and lymphatic system disorders

Hemiparesis

6

Thromboembophlebitis

2

Total

8

Cardiac disorder

Bradycardia

1

Hypotoni

4

Palpitation

1

Tachycardia

10

Cardiac condition

12

Total

28

Eye disorders

Conjunctivitis

1

Eye pressure

6

Ptosis eye lids

1

Pupil dilatation

1

Total

9

Gastrointestinal disorder

Diarrhea

6

Mouth swelling

10

Nausea

50

Vomiting

54

Aphonia

1

Lack of efficacy

1

Stomach pain

4

Total

126

General disorders and administration site conditions

Dizziness

3

Back pain

1

Chills

12

Dead

1

Feeling uncomfortable

1

Injection site reaction

14

Aplasia

2

Loss of consciouness

6

Temperature changes

16

Total

56

Hepatobiliary disorders

Icterus

1

Increase in transaminases

1

Liver damage

1

3

Immune system disorders

Anaphylactic schock/reaction

44

Total

44

Infection and infestations

Pyrogen reaction

1

Total

1

Injury, poisoning and procedural complications

Drug intolerance

2

Total

2

Investigations

Hypotoni

1

Disturbance of heart rhytm

1

Changes in blood pressure

17

Pulse disturbances

6

Total

25

Musculoskeletal and connective tissue disorders

Muscle tremor

3

Total

3

Nervous system disorders

Convulsions

8

Headache

2

Hemiparesis

1

Parasthesia

8

Partial half-page syndrom

1

Restlessness

2

Somnolence

4

Tremble

1

Vertigo

6

Total

33

Psychiatric disorder

Apati

1

Amnesia

1

Anxiety

4

Total

6

Renal and urinary disorders

Kidney pain

1

Oliguria

1

Total

2

Respiratory, thoracic and mediastinal disorders

Cyanosis

8

Difficulty breathing

51

Lung oedema

7

Total

66

Skin and subcutaneous disorders

Blister

23

Erythema

5

Exanthem

15

Itching

2

Oedema

   33

Skin redness

17

Urticaria

44

Total

139

Vascular disorders

Circulatory collaps/schock

42

Cerebral ischamie

1

Total

43

Total ADRs reported  for amiotrizoat natrium

594