Summary

Commonly reported side effects of olaparib include: upper respiratory tract infection, anemia, decreased hemoglobin, increased mcv, increased serum creatinine, nasopharyngitis, nausea, pharyngitis, vomiting, cough, and dyspnea. Continue reading for a comprehensive list of adverse effects.

Applies to olaparib: oral tablet.

Serious side effects of Olaparib

Along with its needed effects, olaparib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking olaparib:

More common

• Black, tarry stools
• bladder pain
• bleeding gums
• bloody or cloudy urine
• body aches or pain
• chest pain or tightness
• chills
• cough
• cough producing mucus
• diarrhea
• difficult, burning, or painful urination
• ear congestion or pain
• fast, pounding, or irregular heartbeat or pulse
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• head congestion
• headache
• hoarseness or other voice changes
• joint pain
• loss of appetite
• loss of voice
• lower back or side pain
• muscle aches and pains
• nausea
• pain or swelling in the arms or legs
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rapid shallow breathing
• runny or stuffy nose
• shivering
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swollen glands
• trouble sleeping
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Incidence not known

• Hives, itching, skin rash
• irritation
• joint stiffness or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• trouble swallowing

Other side effects of Olaparib

Some side effects of olaparib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• belching
• blistering, crusting, irritation, itching, or reddening of the skin
• blurred vision
• burning, numbness, tingling, or painful sensations
• constipation
• cracked, dry, or scaly skin
• decreased appetite
• diarrhea
• difficulty with moving
• dizziness
• dry mouth
• fear or nervousness
• flushed, dry skin
• fruit-like breath odor
• heartburn
• increased hunger
• increased thirst
• increased urination
• indigestion
• lack or loss of strength
• loss of bladder control
• loss of or change in taste
• muscle stiffness
• stomach discomfort, upset, or pain
• swelling or inflammation of the mouth
• unexplained weight loss
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

For Healthcare Professionals

Applies to olaparib: oral capsule, oral tablet.

General

The most common adverse reactions reported in 10% or greater patients were nausea (60%), fatigue (55%), anemia (36%), vomiting (32%), diarrhea (24%), decreased appetite (22%), headache (16%), dysgeusia (15%), cough (15%), neutropenia (14%), dyspnea (14%), dizziness (12%), dyspepsia (12%), leukopenia (11%), and thrombocytopenia (10%).

Cardiovascular

Very common (10% or more): Hypertension (19%)

Common (1% to 10%): Venous thrombosis^[Ref]

Dermatologic

Very common (10% or more): Dermatitis/rash (up to 15%)

Rare (0.01% to 0.1%): Angioedema, erythema nodosum^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 77%), abdominal pain/discomfort (up to 45%), vomiting (up to 40%), diarrhea (up to 37%), dyspepsia (up to 20%), constipation (28%), stomatitis (up to 11%)^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (13%)^[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 98%), elevated mean corpuscular volume (up to 89%), decreased lymphocytes (up to 77%), anemia (up to 46%), decreased absolute neutrophil count (up to 51%), decreased platelets (up to 56%), neutropenia (27%), leukopenia (25%), thrombocytopenia (14%)^[Ref]

The term neutropenia includes febrile neutropenia, granulocyte count decreased, granulocytopenia, neutropenia, neutropenic infection, neutropenic sepsis, and neutrophil count decreased.^[Ref]

Immunologic

Uncommon (0.1% to 1%): Hypersensitivity

Metabolic

Very common (10% or more): Decreased appetite (up to 30%), hypomagnesemia (14%)^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia/ myalgia, back pain (up to 19%)^[Ref]

Nervous system

Very common (10% or more): Headache (up to 26%), dysgeusia (up to 27%), dizziness (up to 20%)^[Ref]

Oncologic

Uncommon (0.1% to 1%): Myelodysplastic syndrome/Acute Myeloid Leukemia^[Ref]

Other

Very common (10% or more): Fatigue/malaise/asthenia/lethargy (up to 67%)

Common (1% to 10%): Pyrexia^[Ref]

Renal

Very common (10% or more): Increased creatinine (up to 30%)^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis/pharyngitis/upper respiratory infection (up to 43%), cough (up to 15%), dyspnea (15%)

Common (1% to 10%): Pulmonary embolism

Uncommon (0.1% to 1%): Pneumonitis

Frequency not reported: Rhinitis^[Ref]