Drug Safety Information for PROTOPIC (Tacrolimus)
Safety-related Labeling Changes for PROGRAF (TACROLIMUS) Rx Drug: FDA Link
Safety-related Labeling Changes for ASTAGRAF XL (TACROLIMUS) Rx Drug: FDA Link
Safety-related Labeling Changes for ENVARSUS XR (TACROLIMUS) Rx Drug: FDA Link
Adverse Drug Reactions for PROTOPIC* (Tacrolimus)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with PROTOPIC
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Death | 1841 |
2 | Drug ineffective | 1689 |
3 | Off label use | 1633 |
4 | Diarrhoea | 1579 |
5 | Pyrexia | 1442 |
6 | Blood creatinine increased | 1108 |
7 | Pneumonia | 1039 |
8 | Sepsis | 1019 |
9 | Renal failure acute | 993 |
10 | Drug interaction | 983 |
11 | Renal failure | 969 |
12 | Transplant rejection | 963 |
13 | Vomiting | 943 |
14 | Nausea* | 936 |
15 | Cytomegalovirus infection | 915 |
16 | Renal impairment | 915 |
17 | Anaemia | 912 |
18 | Kidney transplant rejection | 813 |
19 | Acute graft versus host disease | 740 |
20 | Graft versus host disease | 735 |
* This side effect also appears in "Top 10 Side Effects of PROTOPIC " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking PROTOPIC
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Renal transplant* | 19200 |
2 | Liver transplant* | 12206 |
3 | Immunosuppression | 10082 |
4 | Prophylaxis against transplant rejection | 7156 |
5 | Product used for unknown indication | 6925 |
6 | Prophylaxis against graft versus host disease | 6310 |
7 | Rheumatoid arthritis | 3761 |
8 | Heart transplant* | 3408 |
9 | Immunosuppressant drug therapy | 3154 |
10 | Lung transplant | 2743 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for PROTOPIC
Total Reports Filed with FDA: 139656
Number of FDA Adverse Event Reports by Patient Age for PROTOPIC
Total Reports Filed with FDA: 139656*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tacrolimus (Astagraf xl, Fk 506, Envarsus xr, Prograft, Fk506, Fk-506, Hecoria, Protopic, Prograf, Tacrolimus)
Charts are based on 139656 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
Click to go back to search results and PROTOPIC Reviews and Review Summary .
Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.