Drug Safety Information for XELJANZ (Tofacitinib citrate)

FDA Safety Communication for XELJANZ (TOFACITINIB CITRATE) Rx Drug: FDA Link

Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)

Safety-related Labeling Changes for XELJANZ (TOFACITINIB CITRATE) Rx Drug: FDA Link

Required post-approval safety study:

A randomized withdrawal, double-blind, placebo-controlled trial to evaluate the efficacy and safety of tofacitinib in children from 2 to less than 18 years of age with polyarticular-course juvenile idiopathic arthritis. Due Date: 2020-02-28

Required post-approval safety study:

Controlled clinical trial to evaluate the long term safety of tofacitinib in patients with rheumatoid arthritis. The trial should include two doses of tofacitinib and an active comparator. The trial should be of sufficient size and duration to evaluate safety events of interest, including cardiovascular adverse events, opportunistic infections, and malignancy. Due Date: 2020-06-30

Original FDA Drug Approval Date for XELJANZ: 2012-11-06

Adverse Drug Reactions for XELJANZ* (Tofacitinib citrate)

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 XELJANZ
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective719
2Headache530
3Pain375
4Diarrhoea355
5Nausea354
6Fatigue340
7Arthralgia275
8Rheumatoid arthritis242
9Malaise235
10Pain in extremity223
11Condition aggravated193
12Nasopharyngitis191
13Abdominal pain upper189
14Abdominal discomfort181
15Joint swelling178
16Rash172
17Dizziness158
18Cough155
19Sinusitis155
20Dyspnoea146

* This side effect also appears in "Top 10 Side Effects of XELJANZ " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking XELJANZ
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Rheumatoid arthritis11540
2Product used for unknown indication642
3Arthritis217
4Psoriasis205
5Psoriatic arthropathy90
6Hypertension32
7Systemic lupus erythematosus28
8Crohn's disease27
9Colitis ulcerative27
10Fatigue24

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for XELJANZ

Total Reports Filed with FDA: 17393


Number of FDA Adverse Event Reports by Patient Age for XELJANZ

Total Reports Filed with FDA: 17393*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tofacitinib citrate (Xeljanz)

Charts are based on 17393 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 XELJANZ 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.