Cladribine Novaplus Side Effects

Generic Name: cladribine

Note: This page contains information about the side effects of cladribine. Some of the dosage forms included on this document may not apply to the brand name Cladribine Novaplus.

Not all side effects for Cladribine Novaplus may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to cladribine: intravenous solution

Along with its needed effects, cladribine (the active ingredient contained in Cladribine Novaplus) may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests.

Also, because of the way cancer medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer. Discuss these possible effects with your doctor.

You should check with your doctor immediately if any of these side effects occur when taking cladribine:

More common
  • Black, tarry stools
  • blood in urine
  • cough or hoarseness, accompanied by fever or chills
  • fever
  • lower back or side pain, accompanied by fever or chills
  • painful or difficult urination, accompanied by fever or chills
  • pinpoint red spots on skin
  • unusual bleeding or bruising

If any of the following side effects occur while taking cladribine, check with your doctor or nurse as soon as possible:

More common
  • Skin rash
Less common
  • Pain or redness at place of injection
  • shortness of breath
  • stomach pain
  • swelling of feet or lower legs
  • unusually fast heartbeat

This medicine may also cause the following side effects that your doctor will watch out for:

More common
  • Anemia
  • low white cell counts in blood

Some of the side effects that can occur with cladribine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Headache
  • loss of appetite
  • nausea
  • unusual tiredness
  • vomiting
Less common
  • Constipation
  • diarrhea
  • dizziness
  • general feeling of discomfort or illness
  • itching
  • muscle or joint pain
  • sweating
  • trouble in sleeping
  • weakness

For Healthcare Professionals

Applies to cladribine: intravenous solution


Very common (10% or more): Neutropenia (up to 70%), anemia (up to 37%), thrombocytopenia (up to 12%)
Common (1% to 10%): Febrile neutropenia (8%)
Postmarketing reports: Bone marrow suppression with pancytopenia, aplastic anemia, hemolytic anemia, myelodysplastic syndrome


Postmarketing reports: Acute renal failure, renal impairment


Very common (10% or more): Nausea (22%)
Common (1% to 10%): Vomiting (9%), diarrhea (7%), constipation (4%), abdominal pain (4%), flatulence (1%)


Very common (10% or more): Rash (16%)
Common (1% to 10%): Hyperhidrosis (3%), petechiae (2%), pruritus (2%), ecchymosis (2%)
Postmarketing reports: Urticaria, hypereosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis

Nervous system

Very common (10% or more): Headache (14%)
Common (1% to 10%): Dizziness (6%)
Postmarketing reports: Depressed level of consciousness, neurological toxicity (including peripheral sensory neuropathy, motor neuropathy, polyneuropathy, paraparesis)

Profound (proximal > distal) extremity motor weakness has been described in some patients who received relatively large doses of 0.45 to 0.52 mg/kg per day. Some affected patients were unable to walk and experienced numbness, paresthesia, and hyperesthesia. Nerve conduction velocity studies in affected patients showed markedly decreased compound muscle action potential amplitude, absent or delayed F-wave and H-reflex responses, and (per EMG) polyphasic potentials without evidence of myopathic changes. Overall, the findings were consistent with a symmetric axonal peripheral polyneuropathy with prominent motor involvement.


Very common (10% or more): Administration site reaction (11%)


Postmarketing reports: Tumor lysis syndrome


Common (1% to 10%): Tachycardia (2%)


Common (1% to 10%): Myalgia (6%), pain (6%), arthralgia (6%), muscular weakness (1%)


Common (1% to 10%): Cough (7%), dyspnea (5%), abnormal breath sounds (4%), rales (1%)
Postmarketing reports: Pulmonary interstitial infiltrates (including lung infiltration, interstitial lung disease, pneumonitis and pulmonary fibrosis)


Postmarketing reports: Hypersensitivity


Postmarketing reports: Increased bilirubin, increased transaminases


Very common (10% or more): Infection (up to 28%)
Common (1% to 10%): Serious infection (up to 6%)
Postmarketing reports: Septic shock, opportunistic infections


Postmarketing reports: Conjunctivitis


Very common (10% or more): Pyrexia (33%), fatigue (31%),
Common (1% to 10%): Decreased appetite (8%), asthenia (6%), malaise (5%), chills (2%), peripheral edema (2%), contusion (1%)

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