Olaparib side effects

What does the patient leaflet say about side effects?

From the patient leaflet: What is the most important information I should know about Lynparza?

Lynparza may cause serious side effects, including: • Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have received previous treatment with chemotherapy, radiotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with Lynparza. MDS or AML may lead to death. Symptoms of low blood cell counts are common during treatment with Lynparza, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include: ∘ weakness ∘ weight loss ∘ fever ∘ frequent infections ∘ blood in urine or stool ∘ shortness of breath ∘ feeling very tired ∘ bruising or bleeding more easily Your healthcare provider will do blood tests to check your blood cell counts: ∘ before treatment with Lynparza ∘ every month during treatment with Lynparza ∘ weekly if you have low blood cell counts that last a long time. • Lung problems (Pneumonitis). Lynparza can cause serious lung problems that can lead to death. Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. • Blood clots (Venous Thromboembolism, [VTE]). Some people may develop a blood clot in a deep vein, usually in the leg (venous thrombosis), or a clot in the lungs (pulmonary embolism, [PE]) which may be severe or lead to death. Tell your healthcare provider right away if you have any symptoms such as pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal (tachypnea), or heart beats faster than normal (tachycardia). […]

What does the label list?

From the label: adverse reactions

Most common adverse reactions (≥10%): • as a single agent were nausea, fatigue (including asthenia), anemia, vomiting, diarrhea, decreased appetite, headache, dysgeusia, cough, neutropenia, dyspnea, dizziness, dyspepsia, leukopenia, and thrombocytopenia.

Table 2 Adverse Reactions Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. in SOLO-1 (≥10% of Patients Who Received Lynparza)

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following adverse reactions are discussed elsewhere in the labeling: • Myelodysplastic Syndrome/Acute Myeloid Leukemia [see Warnings and Precautions (5.1) ] • Pneumonitis [see Warnings and Precautions (5.2) ] • Venous Thromboembolism [see Warnings and Precautions (5.3) ] • Hepatotoxicity, Including Drug-Induced Liver Injury [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥10%): • as a single agent were nausea, fatigue (including asthenia), anemia, vomiting, diarrhea, decreased appetite, headache, dysgeusia, cough, neutropenia, dyspnea, dizziness, dyspepsia, leukopenia, and thrombocytopenia. (6.1) • in combination with bevacizumab were nausea, fatigue (including asthenia), anemia, lymphopenia, vomiting, diarrhea, neutropenia, leukopenia, urinary tract infection, and headache. ( 6.1 ) • in combination with abiraterone and prednisone or prednisolone were anemia, fatigue, nausea, diarrhea, decreased appetite, lymphopenia, dizziness, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

What do FAERS reports show?

20,798 reports list olaparib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,936 are coded as a death and 3,825 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

• 506
• 649
• 851
• 1,426
• 2,047
• 2,215
• 2,367
• 2,863
• 3,375
• 2,746
• 1,368

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The 25 most reported reactions

• Death (an outcome recorded in the report)4,729
• Malignant Neoplasm Progression2,063
• Nausea (named in the label)1,827
• Fatigue (named in the label)1,762
• Anaemia (named in the label)1,622
• Off Label Use (a use or a product term, not a reaction)934
• Vomiting (named in the label)724
• Drug Ineffective (a use or a product term, not a reaction)677
• Neuropathy Peripheral649
• Diarrhoea (named in the label)615
• Asthenia (named in the label)613
• Decreased Appetite (named in the label)543
• Disease Progression (a use or a product term, not a reaction)517
• Myelodysplastic Syndrome (named in the label)481
• Haemoglobin Decreased (named in the label)441
• Constipation (named in the label)438
• Myelosuppression432
• Headache (named in the label)404
• Platelet Count Decreased (named in the label)401
• Pain400
• Dyspnoea (named in the label)398
• Product Dose Omission Issue (a use or a product term, not a reaction)397
• Interstitial Lung Disease384
• Malaise (named in the label)383
• Renal Impairment371

What next?

Olaparib: the full record

label, generics, price, shortages, recalls

Report a side effect to the FDA

MedWatch

Side effects hub

the most reported medicines and reactions