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

Table 5: Characteristics of adverse drug reactions reported for amiotrizoat natrium used as contrast media (ATC group V08AA01) in the German Democratic Republic, 1982 to 1990.