Drug Safety Information for IBRANCE (Palbociclib)

FDA Safety-related Labeling Changes for IBRANCE (PALBOCICLIB) Rx Drug: Safety Information Link

Interstitial Lung Disease/Pneumonitis Safety label updated

Required post-approval safety study:

Submit the overall survival (OS) data and results from Trial A5481008, PALOMA-2, ""A Randomized, Multicenter, Double- blind Phase 3 Study of PD- 0332991 (Oral CDK 4/6 Inhibitor) Plus Letrozole Versus Placebo Plus Letrozole for the Treatment of Postmenopausal Women with ER (+), HER2 (-) Breast Cancer Who Have Not Received Any Prior Systemic Anti-Cancer Treatment For Advanced Disease"". Due Date: 2020-11-30

Original FDA Drug Approval Date for IBRANCE: 2015-02-03

Adverse Drug Reactions for IBRANCE* (Palbociclib)

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 IBRANCE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Fatigue	110
2	Neutropenia	105
3	White blood cell count decreased	89
4	Nausea	68
5	Disease progression	39
6	Vomiting	32
7	Diarrhoea	30
8	Platelet count decreased	25
9	Alopecia	24
10	Stomatitis	23
11	Dyspnoea	22
12	Death	20
13	Thrombocytopenia	19
14	Pneumonia	18
15	Asthenia	18
16	Blood count abnormal	17
17	Dizziness	17
18	Neoplasm malignant	16
19	Haemoglobin decreased	16
20	Leukopenia	16

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

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

	Reason	# of FDA Reports
1	Breast cancer	571
2	Breast cancer metastatic	267
3	Neoplasm malignant	65
4	Breast cancer female	51
5	Product used for unknown indication	49
6	Breast cancer stage iv	32
7	Malignant melanoma	16
8	Squamous cell carcinoma	14
9	Malignant nipple neoplasm	10
10	Pancreatic carcinoma metastatic	9

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

Types of Adverse Events for IBRANCE

Total Reports Filed with FDA: 1556

Number of FDA Adverse Event Reports by Patient Age for IBRANCE

Total Reports Filed with FDA: 1556*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Palbociclib (Ibrance)

Charts are based on 1556 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.

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.