Blood Coagulation Factors [CS] — Common Side Effects
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| Side Effect | Total Reports | Drugs | Deaths | Hosp. | Life-Threat. |
|---|---|---|---|---|---|
| Foetal exposure during pregnancy | 40 | 1 | 0 | 26 | 1 |
| Drug ineffective | 39 | 2 | 11 | 11 | 8 |
| No adverse event | 38 | 1 | 3 | 9 | 3 |
| Off label use | 38 | 1 | 7 | 10 | 6 |
| Hypotension | 31 | 1 | 0 | 4 | 15 |
| Foetal anaemia | 27 | 1 | 0 | 27 | 0 |
| Foetal growth restriction | 27 | 1 | 0 | 27 | 0 |
| Haemorrhage in pregnancy | 26 | 1 | 0 | 26 | 0 |
| Anaphylactic shock | 25 | 1 | 0 | 8 | 18 |
| Maternal exposure during pregnancy | 25 | 1 | 0 | 16 | 1 |
| Haemorrhage foetal | 24 | 1 | 0 | 24 | 0 |
| Blood pressure increased | 22 | 1 | 0 | 1 | 10 |
| Haemorrhage | 21 | 1 | 3 | 3 | 10 |
| Hypertension | 19 | 1 | 1 | 2 | 0 |
| Anaphylactic reaction | 18 | 1 | 0 | 1 | 14 |
| Pneumonia | 18 | 1 | 0 | 2 | 1 |
| Tachycardia | 18 | 1 | 0 | 0 | 11 |
| Pleural effusion | 17 | 1 | 2 | 2 | 10 |
| Pyrexia | 17 | 1 | 0 | 8 | 3 |
| Acute kidney injury | 16 | 1 | 2 | 11 | 7 |
| Premature baby | 16 | 1 | 0 | 2 | 1 |
| Shock haemorrhagic | 16 | 1 | 4 | 5 | 14 |
| Disease recurrence | 15 | 1 | 0 | 0 | 0 |
| Infusion site thrombosis | 15 | 1 | 0 | 15 | 0 |
| Urticaria | 15 | 1 | 0 | 1 | 11 |
| Pneumothorax | 13 | 1 | 0 | 1 | 11 |
| Product use in unapproved indication | 13 | 1 | 1 | 2 | 0 |
| Congenital dysfibrinogenaemia | 12 | 1 | 0 | 12 | 0 |
| Face oedema | 12 | 1 | 0 | 1 | 10 |
| Foetal-maternal haemorrhage | 12 | 1 | 0 | 12 | 0 |