Drug Safety Information for LYNPARZA (Olaparib)

Safety-related Labeling Changes for LYNPARZA (OLAPARIB) Rx Drug: FDA Link

Safety-related Labeling Changes for LYNPARZA (OLAPARIB) Rx Drug: FDA Link

Required post-approval safety study:

Submit the progression-free survival (PFS) and molecular characteristics (patient and tumor) final report, labeling, and datasets from clinical trial D0816C00020, entitled, ""OPINION - A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed non-Germline BRCA mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy. Due Date: 2021-06-30

Original FDA Drug Approval Date for LYNPARZA: 2017-08-17

Adverse Drug Reactions for LYNPARZA* (Olaparib)

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 LYNPARZA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea43
2Fatigue25
3Vomiting22
4Diarrhoea13
5Anaemia10
6Decreased appetite8
7Dysphagia8
8Constipation8
9Asthenia7
10Off label use7
11Dizziness6
12Haemoglobin decreased6
13Thrombocytopenia6
14Cognitive disorder6
15Rash6
16Pneumonitis6
17Arthralgia6
18Death6
19Disease progression6
20Malaise5

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

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

Reason # of FDA Reports
1Ovarian cancer318
2Malignant peritoneal neoplasm19
3Brca1 gene mutation19
4Breast cancer14
5Neoplasm11
6Laryngeal cancer10
7Neoplasm malignant7
8Ovarian cancer recurrent7
9Neoplasm prostate6
10Breast cancer metastatic6

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


Types of Adverse Events for LYNPARZA

Total Reports Filed with FDA: 510


Number of FDA Adverse Event Reports by Patient Age for LYNPARZA

Total Reports Filed with FDA: 510*


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

Charts are based on 510 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 LYNPARZA 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.