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Table 2 Description of high quality reports concerning substances reported more than once

From: Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study

Age (years)

Sex

Suspected substance/s

Dose

ADR diagnosis

Serious*

Unexpected*

New drug and not common ADR**

Treatment duration

Time to ADR onset

Positive dechallange

Concomitant medication

Causality

assessment*

55

F

Acetylsalicylic acid/caffeine

500/50 mg

Pruritus

N

Y

N

1 dose

Hours

NR

NR

Probable

63

F

Acetylsalicylic acid

NR

Haemorrhagic gastric ulcer

Y

N

N

NR

NR

Y

Candesartan

Possible

80

F

Acetylsalicylic acid

NR

Gastrointestinal

haemorrhage

Y

N

N

8 weeks

8 weeks

Died

NR

Possible

56

F

Citalopram

60 mg

Nail disorder

N

Y

N

NR

NR

Medication continued

Folic acid

Propiomazine

Diazepam

Levothyroxine

Possible

78

F

Citalopram

Enalapril

Dextropropoxyphene

Omeprazole

Bendroflumethiazide

20 mg

15 mg

150 mg

20 mg

5 mg

Hyponatraemia

Confusion

Y

N

N

NR

NR

Medication continued

Dipyridamole

Budesonide/

formoterol

Tiotropium

Cholecalciferol/calcium

Macrogol, combinations

Vitamin B-complex

Paracetamol

Cyanocobalamin

Sodium picosulfate

Ferrous sulphate

Levothyroxine

Antacids, salt combination

Acetylcysteine

Possible

38

F

Enalapril

5 mg

Yawning

N

Y

N

3 weeks

Days

Y

N

Possible

69

F

Enalapril

20 mg

Diplopia

N

Y

N

NR

NR

Medication continued

N

Possible

35

F

Levonorgestrel

NR

Fatigue

Myalgia

N

Y

Y

N

15 months

Days

Y

Paracetamol

Tramadol

Possible

38

F

Levonorgestrel

NR

Ectopic pregnancy

Y

N

N

4 years

4 years

Y

N

Possible

49

M

Varenicline

1 mg

Thrombophlebitis

N

Y

Y

2 months

2 months

NR

Atenolol

Possible

61

F

Varenicline

2 mg

Confusion

N

Y

Y

2 weeks

NR

Y

Dipyridamole

Simvastatin

Possible

62

F

Varenicline

NR

Macula-degeneration

N

Y

Y

4 months

5 months

NR

NR

Unclassifiable

66

F

Varenicline

NR

Oedema legs

Y

Y

Y

5 weeks

4 weeks

N

Naproxen

Omeprazole

Folic acid

Possible

  1. *According to the World Health Organization (WHO)[3]
  2. **Concerning new drugs and not labelled as common in the SPC
  3. ADR, adverse drug reaction; F, female; M, male; N, no; NR, not reported; Y, yes