Rubraca Side Effects

Generic name: rucaparib

Medically reviewed by Drugs.com. Last updated on Apr 13, 2025.

Note: This document provides detailed information about Rubraca.

Applies to rucaparib: oral tablet Side Effects associated with rucaparib. Some dosage forms listed on this page may not apply specifically to the brand name Rubraca.

Applies to rucaparib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to check for any problems that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment with this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not donate sperm while you are using this medicine and for at least 3 months after your last dose.

Tell your doctor if you have blood in the urine or stools, fever or chills, cough, sore throat, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of a bone marrow problem called myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

This medicine may make your skin more sensitive to sunlight. Use sunscreen or sunblock lotion and lip balm with a sun protection factor (SPF) of at least 30 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 A.M. and 3 P.M. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Rubraca

Along with its needed effects, rucaparib (the active ingredient contained in Rubraca) 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 rucaparib:

Other side effects of Rubraca

Some side effects of rucaparib 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:

For healthcare professionals

Applies to rucaparib: oral tablet.

General adverse events

The most common adverse reactions in patients with ovarian cancer were nausea, fatigue/asthenia, anemia, abdominal pain, increased ALT, increased AST, vomiting, diarrhea, decreased appetite, thrombocytopenia, dysgeusia, neutropenia, increased blood creatinine, dyspnea, dizziness, dyspepsia, photosensitivity reaction, and leukopenia.

The most common adverse reactions in patients with BRCA (breast cancer gene)-mutated metastatic castration-resistant prostate cancer (mCRPC) were fatigue/asthenia, nausea, anemia, increased ALT, increased AST, decreased appetite, rash, constipation, thrombocytopenia, vomiting, and diarrhea.^[Ref]

Cardiovascular

• Frequency not reported: ECG QT prolonged, cardiac failure, ischemic cardiovascular events, venous thromboembolism

Dermatologic

• Very common (10% or more): Rash (includes blister, blood blister, dermatitis, contact dermatitis, eczema, genital rash, palmar-plantar erythrodysesthesia syndrome, photosensitivity reaction, psoriasis, rash, maculopapular rash, pruritic rash, skin exfoliation, skin lesion, urticaria; up to 45%), photosensitivity reaction (up to 12%)
• Common (1% to 10%): Maculopapular rash, palmar-plantar erythrodysesthesia syndrome, erythema, pruritus

Pruritus was reported in 14% of patients 75 years and older compared with 9% of patients younger than 75 years.

Gastrointestinal

• Very common (10% or more): Nausea (up to 79%), abdominal pain (includes abdominal pain, abdominal distention, lower abdominal pain, upper abdominal pain; up to 48%), constipation (up to 39%), vomiting (up to 37%), diarrhea (up to 34%), stomatitis (up to 28%), dyspepsia (up to 12%)
• Common (1% to 10%): Intestinal obstruction (includes intestinal obstruction, large intestinal obstruction, small intestinal obstruction)

Genitourinary

• Frequency not reported: Urinary tract infection

Hematologic

• Very common (10% or more): Decreased leukocytes (up to 69%), decreased absolute neutrophil count (includes decreased neutrophils; up to 62%), decreased hemoglobin (up to 61%), decreased platelets (up to 47%), anemia (up to 45%), decreased lymphocytes (up to 42%), thrombocytopenia (includes decreased platelet count; up to 35%), neutropenia (up to 22%), leukopenia (includes decreased WBC count; 10%)
• Common (1% to 10%): Lymphopenia, febrile neutropenia
• Frequency not reported: Bleeding, myelosuppression

Anemia and thrombocytopenia (grade 3 or higher) were reported in 31% and 10%, respectively, of patients with moderate renal dysfunction (CrCl 30 to 59 mL/min) compared with 21% and 5%, respectively, of patients with normal renal function (CrCl greater than 90 mL/min).

The time of onset for myelosuppression (grade 3 or higher) was generally later in treatment (after 2 or more months).

Hepatic

• Very common (10% or more): Increased ALT (up to 69%), increased AST (up to 59%), increased ALT/AST (up to 39%)
• Common (1% to 10%): Increased transaminases
• Frequency not reported: Increased bilirubin

Events related to increases in ALT and AST occurred within the first few weeks of therapy, were reversible, and were rarely associated with increases in bilirubin.

Increased ALT/AST combined (grade 3 or higher) was reported in 12% of patients with moderate renal dysfunction compared with 7% of patients with normal renal function.

Hypersensitivity

• Common (1% to 10%): Hypersensitivity (include hypersensitivity, drug hypersensitivity, swelling/edema of the face, swelling/edema of the eyes/periorbital swelling, flushing, asthma, choking sensation, wheezing)

Metabolic

• Very common (10% or more): Decreased appetite (up to 28%)
• Common (1% to 10%): Hypophosphatemia, hypercholesterolemia, dehydration

Nervous system

• Very common (10% or more): Dysgeusia (up to 33%), headache (up to 22%), dizziness (up to 15%)
• Common (1% to 10%): Memory impairment
• Frequency not reported: Balance disorder

Dizziness and memory impairment were reported in 19% and 4%, respectively, of patients 75 years and older compared with 13% and 1%, respectively, of patients younger than 75 years.

Oncologic

• Common (1% to 10%): Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)

MDS/AML has occurred in patients treated with this drug. In 1594 treated patients with ovarian cancer, MDS/AML occurred in 32 patients, including those in long term follow-up; of these, 14 occurred during therapy or during the 28-day safety follow-up. The duration of therapy before the diagnosis of MDS/AML ranged from less than 2 to about 72 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents.

In a study of patients with a germline and/or somatic BRCA mutation, MDS/AML occurred in 9 out of 129 patients treated with this drug. The duration of therapy in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.

Other

• Very common (10% or more): Fatigue (includes fatigue, asthenia, lethargy; up to 74%), decreased phosphate (up to 68%), increased alkaline phosphatase (up to 44%), increased triglycerides (up to 42%), increased cholesterol (up to 39%), decreased sodium (up to 38%), pyrexia (up to 15%), peripheral edema (up to 12%)
• Frequency not reported: Decreased weight, sepsis

Fatigue/asthenia (grade 3 or higher) was reported in 13% of patients with moderate renal dysfunction compared with 8% of patients with normal renal function.

Psychiatric

• Very common (10% or more): Insomnia (up to 19%), depression (up to 11%)

Renal

• Very common (10% or more): Increased blood creatinine (up to 96%)
• Common (1% to 10%): Acute kidney injury
• Frequency not reported: Renal failure

Increases in serum creatinine, primarily mild to moderate (grade 1 or 2), were observed in 20% of patients within the first few weeks of therapy. These increases in serum creatinine were clinically asymptomatic.

Increased blood creatinine was reported in 33% of patients 75 years and older compared with 18% of patients younger than 75 years.

Respiratory

• Very common (10% or more): Nasopharyngitis/upper respiratory tract infection (up to 29%), dyspnea (up to 17%)
• Frequency not reported: Acute respiratory distress syndrome, pneumonia

See also:

Frequently asked questions

• What type of cancer is Rubraca used to treat?

Further information

Rubraca side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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