OLAPARIB

N/A

Manufactured by AstraZeneca Pharmaceuticals LP

33,417 FDA adverse event reports analyzed

Last updated: 2026-04-14

About OLAPARIB

OLAPARIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. The most commonly reported adverse reactions for OLAPARIB include DEATH, MALIGNANT NEOPLASM PROGRESSION, NAUSEA, FATIGUE, ANAEMIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OLAPARIB.

Top Adverse Reactions

DEATH4,519 reports
MALIGNANT NEOPLASM PROGRESSION1,959 reports
NAUSEA1,694 reports
FATIGUE1,595 reports
ANAEMIA1,522 reports
OFF LABEL USE873 reports
VOMITING682 reports
DRUG INEFFECTIVE644 reports
DIARRHOEA582 reports
ASTHENIA554 reports
DECREASED APPETITE504 reports
NEUROPATHY PERIPHERAL496 reports
DISEASE PROGRESSION473 reports
MYELODYSPLASTIC SYNDROME462 reports
HAEMOGLOBIN DECREASED412 reports
CONSTIPATION392 reports
MYELOSUPPRESSION392 reports
PLATELET COUNT DECREASED382 reports
HEADACHE378 reports
INTERSTITIAL LUNG DISEASE374 reports
MALAISE370 reports
PAIN370 reports
DYSPNOEA368 reports
THROMBOCYTOPENIA348 reports
PRODUCT DOSE OMISSION ISSUE344 reports
OVARIAN CANCER RECURRENT337 reports
DIZZINESS336 reports
ACUTE MYELOID LEUKAEMIA329 reports
ARTHRALGIA328 reports
RENAL IMPAIRMENT307 reports
PRODUCT USE ISSUE301 reports
CARBOHYDRATE ANTIGEN 125 INCREASED290 reports
PANCYTOPENIA290 reports
WHITE BLOOD CELL COUNT DECREASED286 reports
PRODUCT USE IN UNAPPROVED INDICATION271 reports
PYREXIA257 reports
WEIGHT DECREASED231 reports
NEUTROPHIL COUNT DECREASED221 reports
RASH217 reports
NEUTROPENIA212 reports
TOXICITY TO VARIOUS AGENTS210 reports
ABDOMINAL PAIN209 reports
FALL207 reports
PROSTATIC SPECIFIC ANTIGEN INCREASED205 reports
METASTASES TO LIVER200 reports
ABDOMINAL PAIN UPPER185 reports
PNEUMONIA183 reports
TUMOUR MARKER INCREASED183 reports
BACK PAIN179 reports
PAIN IN EXTREMITY174 reports
COUGH172 reports
METASTASES TO BONE170 reports
ABDOMINAL DISCOMFORT169 reports
THROMBOSIS169 reports
RED BLOOD CELL COUNT DECREASED168 reports
RENAL FAILURE165 reports
BLOOD CREATININE INCREASED164 reports
MYALGIA164 reports
FULL BLOOD COUNT DECREASED158 reports
HYPERTENSION158 reports
DEHYDRATION157 reports
INSOMNIA155 reports
DYSPHAGIA152 reports
PERIPHERAL SWELLING152 reports
HAEMATOTOXICITY151 reports
NEOPLASM MALIGNANT148 reports
DYSPEPSIA146 reports
PRURITUS145 reports
DRUG INTERACTION142 reports
FEELING ABNORMAL142 reports
ILLNESS136 reports
DRUG INTOLERANCE134 reports
INTESTINAL OBSTRUCTION134 reports
PLEURAL EFFUSION133 reports
UNDERDOSE130 reports
METASTASES TO CENTRAL NERVOUS SYSTEM128 reports
ASCITES126 reports
PNEUMONITIS126 reports
COVID 19123 reports
GENERAL PHYSICAL HEALTH DETERIORATION123 reports
ABDOMINAL DISTENSION121 reports
HYPOAESTHESIA119 reports
TASTE DISORDER119 reports
URINARY TRACT INFECTION117 reports
ALOPECIA116 reports
FULL BLOOD COUNT ABNORMAL111 reports
METASTASES TO LYMPH NODES110 reports
ANXIETY109 reports
GAIT DISTURBANCE109 reports
DYSGEUSIA108 reports
BONE PAIN106 reports
MUSCLE SPASMS105 reports
SOMNOLENCE105 reports
HYPOTENSION102 reports
CEREBROVASCULAR ACCIDENT101 reports
INFECTION101 reports
BLOOD PRESSURE INCREASED96 reports
DEPRESSION96 reports
DRUG RESISTANCE95 reports
OVARIAN CANCER94 reports

Report Outcomes

Out of 19,391 classified reports for OLAPARIB:

Serious 90.5%Non-Serious 9.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female13,704 (77.7%)
Male3,944 (22.3%)

Reports by Age

Age 70245 reports
Age 68207 reports
Age 65200 reports
Age 60199 reports
Age 63195 reports
Age 72180 reports
Age 59175 reports
Age 62175 reports
Age 66173 reports
Age 71166 reports
Age 61165 reports
Age 67162 reports
Age 69162 reports
Age 75158 reports
Age 58156 reports
Age 55154 reports
Age 64154 reports
Age 50153 reports
Age 57146 reports
Age 73146 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with OLAPARIB?

This profile reflects 33,417 FDA FAERS reports that mention OLAPARIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OLAPARIB?

Frequently reported terms in FAERS include DEATH, MALIGNANT NEOPLASM PROGRESSION, NAUSEA, FATIGUE, ANAEMIA, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures OLAPARIB?

Labeling and FAERS entries often list AstraZeneca Pharmaceuticals LP in connection with OLAPARIB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.