Cerubidine (Daunorubicin Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Dose-limiting toxicity includes myelosuppression and cardiotoxicity (See WARNINGS). Other reactions include:

Cutaneous

Reversible alopecia occurs in most patients. Rash, contact dermatitis and urticaria have occurred rarely.

Gastrointestinal

Acute nausea and vomiting occur but are usually mild. Antiemetic therapy may be of some help. Mucositis may occur 3 to 7 days after administration. Diarrhea and abdominal pain have occasionally been reported.

Local

If extravasation occurs during administration, severe local tissue necrosis, severe cellulitis, thrombophlebitis, or painful induration can result.

Acute Reactions

Rarely, anaphylactoid reaction, fever, and chills can occur. Hyperuricemia may occur, especially in patients with leukemia, and serum uric acid levels should be monitored.

REPORTS OF SUSPECTED CERUBIDINE SIDE EFFECTS / ADVERSE REACTIONS

Possible Cerubidine side effects / adverse reactions in 59 year old male

Reported by a physician from United States on 2011-10-04

Patient: 59 year old male

Reactions: Status Epilepticus, Pyrexia

Suspect drug(s):
Cerubidine
    Dosage: 70 mg, qd
    Indication: Acute Leukaemia
    Start date: 2008-11-14
    End date: 2008-11-16

Mylotarg
    Dosage: 12 mg, qd
    Indication: Acute Leukaemia
    Start date: 2008-11-17
    End date: 2008-11-17

Ciprofloxacin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Cytarabine
    Dosage: 400 mg, qd
    Indication: Acute Myeloid Leukaemia
    Start date: 2008-11-14
    End date: 2008-11-17

Other drugs received by patient: Gentamicin; Rocephin

Possible Cerubidine side effects / adverse reactions in 56 year old male

Reported by a physician from France on 2011-10-04

Patient: 56 year old male

Reactions: Septic Shock

Adverse event resulted in: death, life threatening event

Suspect drug(s):
Cytarabine
    Dosage: 200 mg/m2, 1x/day
    Indication: Acute Myeloid Leukaemia
    Start date: 2010-08-13
    End date: 2010-08-19

Gemtuzumab Ozogamicin
    Dosage: 6 mg/m2, 1x/day
    Indication: Acute Myeloid Leukaemia
    Start date: 2010-08-16
    End date: 2010-08-16

Cerubidine
    Dosage: 60 mg/m2, 1x/day
    Indication: Acute Myeloid Leukaemia
    Start date: 2010-08-13
    End date: 2010-08-15

Possible Cerubidine side effects / adverse reactions in 53 year old male

Reported by a physician from France on 2011-10-10

Patient: 53 year old male

Reactions: Paraesthesia Oral, Cranial Nerve Disorder, Peripheral Sensory Neuropathy, Viith Nerve Paralysis, Lyme Disease

Adverse event resulted in: hospitalization

Suspect drug(s):
Gemtuzumab Ozogamicin
    Dosage: 6 mg/m2 once a day
    Start date: 2010-08-20
    End date: 2011-08-20

Cytarabine
    Dosage: 100 mg, unknown frequency
    Start date: 2010-06-01

Cerubidine
    Dosage: 60 mg/m2, 1x/day
    Indication: Acute Leukaemia
    Start date: 2010-06-04
    End date: 2010-06-06

Cerubidine
    Dosage: unk
    Start date: 2010-07-20
    End date: 2010-07-21

Gemtuzumab Ozogamicin
    Dosage: 6 mg/m2, 1x/day
    Indication: Acute Leukaemia
    Start date: 2010-06-07
    End date: 2010-06-07

Cytarabine
    Dosage: 50 mg/m2, unk
    Start date: 2010-07-20
    End date: 2010-07-26

Cytarabine
    Dosage: 200 mg/m2, 1x/day
    Start date: 2010-06-04
    End date: 2010-06-10

Prednisolone
    Dosage: unk
    Start date: 2010-06-01

Cytarabine
    Dosage: 1000 mg/kg, 2x/day
    Indication: Leukaemia
    Start date: 2010-08-17
    End date: 2010-08-22

Mitoxantrone
    Dosage: 12 mg/m2, 1x/day
    Start date: 2010-08-17
    End date: 2010-08-18

Methotrexate Sodium
    Dosage: unk
    Start date: 2010-06-01

Other drugs received by patient: Lercanidipine; Micardis