CICLOSPORIN for Off label use: Side Effects & Safety Data
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There are 9 adverse event reports in the FDA FAERS database where CICLOSPORIN was used for Off label use.
Most Reported Side Effects for CICLOSPORIN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 74 | 15.6% | 24 | 14 |
| Foetal exposure during pregnancy | 63 | 13.2% | 1 | 3 |
| Low birth weight baby | 57 | 12.0% | 1 | 3 |
| Premature baby | 54 | 11.3% | 0 | 3 |
| Acute graft versus host disease | 41 | 8.6% | 21 | 1 |
| Cytomegalovirus infection | 28 | 5.9% | 13 | 12 |
| Renal impairment | 26 | 5.5% | 7 | 12 |
| Hypertension | 24 | 5.0% | 4 | 8 |
| Pyrexia | 23 | 4.8% | 8 | 17 |
| Blood creatinine increased | 22 | 4.6% | 2 | 10 |
| Blood pressure increased | 22 | 4.6% | 3 | 4 |
| Multi-organ failure | 20 | 4.2% | 19 | 7 |
| Anaemia | 18 | 3.8% | 4 | 6 |
| Angioedema | 18 | 3.8% | 0 | 0 |
| Exposure during pregnancy | 18 | 3.8% | 0 | 5 |
Other Indications for CICLOSPORIN
Prophylaxis against graft versus host disease (95)
Immunosuppression (93)
Prophylaxis against transplant rejection (28)
Product used for unknown indication (23)
Renal transplant (21)
Immunosuppressant drug therapy (14)
Urticaria chronic (11)
Angioedema (10)
Aplastic anaemia (10)
Graft versus host disease (9)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)