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Adriamycin PFS Side Effects

Generic name: doxorubicin

Medically reviewed by Last updated on May 30, 2023.

Note: This document contains side effect information about doxorubicin. Some dosage forms listed on this page may not apply to the brand name Adriamycin PFS.

Applies to doxorubicin: intravenous powder for solution, intravenous solution.


Intravenous route (Solution; Powder for Solution)

Myocardial damage can occur with DOXOrubicin hydrochloride with incidences from 1% to 20% for cumulative doses from 300 to 500 mg/m(2) when DOXOrubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with DOXOrubicin hydrochloride. Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including DOXOrubicin hydrochloride. Extravasation of DOXOrubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. Immediately terminate the drug, and apply ice to the affected area. Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur.

Serious side effects of Adriamycin PFS

Along with its needed effects, doxorubicin (the active ingredient contained in Adriamycin PFS) 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 or nurse immediately if any of the following side effects occur while taking doxorubicin:

Less common


Other side effects of Adriamycin PFS

Some side effects of doxorubicin 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

Less common

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, Check with your doctor immediately if you notice the following side effects:

For Healthcare Professionals

Applies to doxorubicin: compounding powder, intravenous powder for injection, intravenous solution.


Common (1% to 10%): Cardiomyopathy, decreased LVEF, ECG changes (e.g., sinus tachycardia, tachyarrhythmia, ventricular tachycardia, bradycardia, bundle branch block), congestive heart failure

Very rare (less than 0.01%): Pericarditis, myocarditis

Postmarketing reports: Cardiogenic shock, phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism[Ref]


Very common (10% or more): Leucopenia (60% to 80%)

Common (1% to 10%): Bone marrow suppression

Uncommon (0.1% to 1%): Thrombocytopenia[Ref]


Common (1% to 10%): Alopecia

Rare (less than 0.1%): Urticaria, exanthema, local erythematous reactions along the vein which was used for the injection, hyperpigmentation of skin and nails, onycholysis

Postmarketing reports: Oncolysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia[Ref]


Very common (10% or more): Nausea and vomiting (20% to 85%), stomatitis (up to 80%), diarrhea (12%)

Common (1% to 10%): Mucositis

Uncommon (0.1% to 1%): Ulceration and necrosis of the colon, especially the cecum (in combination with cytarabine)[Ref]


Frequency not reported: Extravasation, tissue necrosis[Ref]


Rare (0.01% to 0.1%): Anaphylactic reactions[Ref]


Rare (0.01% to 0.1%): Renal insufficiency[Ref]


Rare (0.01% to 0.1%): Shivering, fever

Frequency not reported: Radiation recall

Postmarketing reports: Malaise, asthenia, fever, chills[Ref]


Common (1% to 10%): Secondary malignancies[Ref]


Rare (0.01% to 0.1%): Conjunctivitis

Postmarketing reports: Keratitis, lacrimation[Ref]


Common (1% to 10%): Local reactions (chemical cystitis) may occur with intravesical treatment

Rare (less than 0.1%): Bladder contracture

Frequency not reported: Amenorrhea[Ref]


Common (1% to 10%): Anorexia

Frequency not reported: Hyperuricemia, tumor lysis syndrome

Postmarketing reports: Weight gain[Ref]


Postmarketing reports: Increased alanine aminotransferase, increased aspartate aminotransferase[Ref]


Common (1% to 10%): Dyspnea

Frequency not reported: Bronchospasm, cough, epistaxis, pneumonia, nasopharyngitis, upper respiratory tract infection[Ref]

Nervous system

Rare (0.01% to 0.1%): Dizziness

Postmarketing reports: Peripheral sensory and motor neuropathy, seizures, coma[Ref]

Frequently asked questions


1. Product Information. Adriamycin PFS (doxorubicin). Pharmacia and Upjohn. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.