Cladribine Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 27, 2024.

Applies to cladribine: oral tablet.

Other dosage forms:

• intravenous solution

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Malignancy. Treatment with cladribine may increase the risk of malignancy.

Cladribine is contraindicated in patients with current malignancy.

In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of cladribine on an individual patient basis.

Follow standard cancer screening guidelines in patients treated with cladribine.Risk of Teratogenicity. Cladribine is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm.

Malformations and embryolethality occurred in animals.

Exclude pregnancy before the start of treatment with cladribine in females of reproductive potential.

Advise females and males of reproductive potential to use effective contraception during cladribine dosing and for 6 months after the last dose in each treatment course.

Stop cladribine if the patient becomes pregnant.

Serious side effects of cladribine

Along with its needed effects, cladribine 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 cladribine:

More common side effects

• body aches or pain
• chills
• cough
• ear congestion
• fast heartbeat
• fever
• headache
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• loss of voice
• lower back or side pain
• painful or difficult urination
• redness of the skin
• runny or stuffy nose
• sneezing
• sore throat
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing
• unusual tiredness or weakness

Less common side effects

• blurred vision
• cough producing mucus
• discouragement
• dizziness
• feeling sad or empty
• lack of appetite
• loss of interest or pleasure
• nervousness
• pounding in the ears
• slow heartbeat
• trouble concentrating
• trouble sleeping

Rare side effects

• burning or stinging of the skin
• confusion
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• seizures
• stiff neck
• vomiting

Incidence not known

• blistering, peeling, loosening of the skin
• chest pain
• diarrhea
• muscle pain
• red skin lesions, often with a purple center
• red, irritated eyes
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• unusual bleeding or bruising

Other side effects of cladribine

Some side effects of cladribine 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 side effects

• back pain
• difficulty in moving
• muscle stiffness
• trouble sleeping

Less common side effects

• thinning or loss of hair

For healthcare professionals

Applies to cladribine: intravenous solution, oral tablet.

Hematologic adverse events

• Very common (10% or more): Neutropenia, thrombocytopenia, anemia, purpura
• Common (1% to 10%): Febrile neutropenia
• Uncommon (0.1% to 1%): Bone marrow suppression with prolonged pancytopenia, aplastic anemia, hypereosinophilia, myelodysplastic syndrome
• Postmarketing reports: Hemolytic anemia, febrile neutropenia^[Ref]

Renal

• Common (1% to 10%): Renal impairment, renal failure

Gastrointestinal

• Very common (10% or more): Nausea (28%), anorexia (17%), vomiting (13%), diarrhea (10%)
• Common (1% to 10%): Constipation, abdominal pain, flatulence
• Uncommon (0.1% to 1%): Mucositis^[Ref]

Dermatologic

• Very common (10% or more): Rash (28%), diaphoresis, pruritus
• Common (1% to 10%): Hyperhidrosis, petechiae, ecchymosis, urticaria
• Uncommon (0.1% to 1%): Stevens-Johnson syndrome, toxic skin eruption, toxic epidermal necrolysis
• Rare (less than 0.1%): Alopecia^[Ref]

Nervous system

• Very common (10% or more): Headache
• Common (1% to 10%): Dizziness, somnolence
• Uncommon (0.1% to 1%): Depressed level of consciousness, neurological toxicity (including peripheral sensory neuropathy, motor neuropathy (paralysis), polyneuropathy, paraparesis)^[Ref]

Local

• Very common (10% or more): Administration site reaction^[Ref]

Metabolic

• Common (1% to 10%): Weight loss
• Uncommon (0.1% to 1%): Tumor lysis syndrome, metabolic acidosis^[Ref]

Cardiovascular

• Common (1% to 10%): Edema, tachycardia, myocardial ischemia, peripheral edema
• Rare (less than 0.1%): Heart failure, arrhythmia, heart murmur, hypotension, thrombosis^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, myalgia
• Uncommon (0.1% to 1%): Muscular weakness, paraparesis^[Ref]

Respiratory

• Very common (10% or more): Cough
• Common (1% to 10%): Pulmonary interstitial infiltrates (including lung infiltration, interstitial lung disease, pneumonitis and pulmonary fibrosis), abnormal breath sounds, abnormal chest sounds, dyspnea, rales^[Ref]

Hypersensitivity

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

Hepatic

• Uncommon (0.1% to 1%): Increases in bilirubin, increases in transaminases, jaundice^[Ref]

Immunologic

• Very common (10% or more): Infection (unspecified) (up to 28%)
• Common (1% to 10%): Bacteremia, cellulitis, localized infection, pneumonia, septic shock, serious infection, opportunistic infection^[Ref]

Ocular

• Postmarketing reports: Conjunctivitis^[Ref]

Other

• Very common (10% or more): Fatigue, pyrexia, pain
• Common (1% to 10%): Asthenia, chills, malaise, localized edema, chills^[Ref]

Oncologic

• Postmarketing reports: Secondary malignancies^[Ref]

Psychiatric

• Common (1% to 10%): Confusion, anxiety, insomnia^[Ref]

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Further information

Cladribine 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.

Medical Disclaimer