Sirolimus

Common brands: Hyftor, Fyarro, Prograf, Envarsus Xr, Tacrolimus

Top reporter: Nobelpharma America, Llc

Kinase Inhibitor [EPC]mTOR Inhibitor Immunosuppressant [EPC]Corticosteroid [EPC]Calcineurin Inhibitor Immunosuppressant [EPC]Alkylating Drug [EPC]
12,953
Total Reports
6,993
Serious Reports
2,096
Death Reports
30
Reported Reactions
Death Report Ratio: High (16.18%)

Patient Demographics

Male
5,996
Female
4,527

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Sirolimus.

# Reaction Reports % of Total
1 OFF LABEL USE 1,964
16.1%
2 DRUG INEFFECTIVE 1,076
8.8%
3 PRODUCT USE IN UNAPPROVED INDICATION 774
6.4%
4 PYREXIA 517
4.2%
5 DIARRHOEA 508
4.2%
6 PNEUMONIA 471
3.9%
7 ACUTE KIDNEY INJURY 429
3.5%
8 DRUG INTERACTION 423
3.5%
9 THROMBOTIC MICROANGIOPATHY 367
3.0%
10 TRANSPLANT REJECTION 362
3.0%
11 CYTOMEGALOVIRUS INFECTION 340
2.8%
12 TOXICITY TO VARIOUS AGENTS 309
2.5%
13 DEATH 301
2.5%
14 CONDITION AGGRAVATED 300
2.5%
15 INFECTION 298
2.4%
16 NAUSEA 295
2.4%
17 SEPSIS 293
2.4%
18 DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 279
2.3%
19 RENAL IMPAIRMENT 264
2.2%
20 FATIGUE 261
2.1%
21 DISEASE PROGRESSION 252
2.1%
22 THROMBOCYTOPENIA 251
2.1%
23 NEUTROPENIA 247
2.0%
24 VOMITING 238
2.0%
25 BLOOD CREATININE INCREASED 237
1.9%
26 RESPIRATORY FAILURE 233
1.9%
27 EPSTEIN-BARR VIRUS INFECTION 230
1.9%
28 ANAEMIA 224
1.8%
29 DYSPNOEA 221
1.8%
30 MULTIPLE ORGAN DYSFUNCTION SYNDROME 220
1.8%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.