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Adriamycin PFS

Last reviewed on RxList: 6/8/2018
Adriamycin PFS Side Effects Center

Last reviewed on RxList 6/8/2018

Adriamycin PFS (doxorubicin hydrochloride) Injection is a cancer (antineoplastic) medication used to treat many types of cancer. The brand name Adriamycin PFS is discontinued in the U.S. Generic forms may be available. Common side effects of Adriamycin PFS (doxorubicin hydrochloride) include:

Adriamycin PFS (doxorubicin hydrochloride) may give a reddish color to urine, tears, and sweat that may last up to several days. This is a normal side effect of Adriamycin PFS (doxorubicin hydrochloride) and should not be mistaken for blood in your urine. Temporary hair loss may occur. Normal hair growth should return after treatment with Adriamycin PFS has ended. Tell your doctor if you have serious side effects of Adriamycin PFS including:

  • cough,
  • hoarseness,
  • persistent diarrhea,
  • redness,
  • flushing of face,
  • eye itching,
  • unusual tiredness,
  • joint pain,
  • pain in the lower back/side/stomach/abdomen,
  • painful or difficult urination,
  • black/tarry stools,
  • bloody mucus or discharge in stools,
  • fast or irregular heartbeat,
  • shortness of breath,
  • dizziness,
  • swelling of ankles or feet, or
  • decreased urination.

Doxorubicin is given intravenously under physician supervision. Dose is determined by clinical factors. Tell your doctor if you have had previous treatment with doxorubicin, doxorubicin liposomal, daunorubicin, daunorubicin liposomal, idarubicin, or mitoxantrone. Doxorubicin may interact with paclitaxel, progesterone, verapamil, cyclosporine, cyclophosphamide, phenobarbital, phenytoin, streptozocin, or "live" vaccines. Tell your doctor all medications you use. Doxorubicin is not recommended for use during pregnancy. It may harm a fetus. Men and women should use two forms of birth control (e.g., condoms and birth control pills) while being treated with this medication and for some time afterward. Consult your doctor to discuss birth control. This medication passes into breast milk. Because of the potential risk to the infant, breastfeeding while using this drug is not recommended.

Our Adriamycin PFS (doxorubicin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Adriamycin PFS Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

  • pain, blisters, or skin sores where the injection was given;
  • missed menstrual periods;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or
  • signs of heart problems--fast heartbeats, shortness of breath (even with mild exertion), swelling in your ankles or feet.

Doxorubicin may cause your urine to turn a reddish-orange color. This side effect by itself is usually not harmful. However, call your doctor if you also have upper stomach pain, clay-colored stools, or jaundice (yellowing of your skin or the whites of your eyes).

Common side effects may include:

  • nausea, vomiting; or
  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Adriamycin PFS (Doxorubicin hydrochloride)

Adriamycin PFS Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling.

  • Cardiomyopathy and Arrhythmias [see WARNINGS AND PRECAUTIONS]
  • Secondary Malignancies [see WARNINGS AND PRECAUTIONS]
  • Extravasation and Tissue Necrosis [see WARNINGS AND PRECAUTIONS]
  • Severe Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Radiation Sensitization and Radiation Recall [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience In Breast Cancer

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety data below were collected from 1492 women who received doxorubicin at a dose of 60 mg/m² and cyclophosphamide at a dose of 600 mg/m² (AC) every 3 weeks for 4 cycles for the adjuvant treatment of axillary lymph node positive breast cancer. The median number of cycles received was 4. Selected adverse reactions reported in this study are provided in Table 1. No treatment-related deaths were reported in patients on either arm of the study.

Table 1: Selected Adverse Reactions in Patients with Early Breast Cancer Involving Axillary Lymph Nodes

Adverse reactions, % of patients AC*
N=1492
Conventional CMF
N=739
Leukopenia
Grade 3 (1,000 to 1,999 /mm³) 3.4 9.4
Grade 4 (<1000 /mm³) 0.3 0.3
Thrombocytopenia
Grade 3 (25,000 to 49,999 /mm³) 0 0
Grade 4 (<25,000 /mm³) 0.1 3 0
Shock, sepsis 2 1
Systemic infection 2 1
Vomiting
Vomiting <12 hours 34 25
Vomiting >12 hours 37 12
Intractable 5 2
Alopecia 92 71
Cardiac dysfunction
Asymptomatic 0.2 0.1
Transient 0.1 0
Symptomatic 0.1 0
* Includes pooled data from patients who received either AC alone for 4 cycles, or who were treated with AC for 4 cycles followed by 3 cycles of CMF

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of doxorubicin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac - cardiogenic shock

Cutaneous - Skin and nail hyperpigmentation, oncolysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia

Gastrointestinal - Nausea, mucositis, stomatitis, necrotizing colitis, typhlitis, gastric erosions, gastrointestinal tract bleeding, hematochezia, esophagitis, anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of the oral mucosa

Hypersensitivity - Anaphylaxis

Laboratory Abnormalities -Increased alanine aminotransferase, increased aspartate aminotransferase

Neurological - Peripheral sensory and motor neuropathy, seizures, coma

Ocular - Conjunctivitis, keratitis, lacrimation

Vascular - Phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism

Other - Malaise/asthenia, fever, chills, weight gain

Read the entire FDA prescribing information for Adriamycin PFS (Doxorubicin hydrochloride)

Related Resources for Adriamycin PFS

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Read the Adriamycin PFS User Reviews »

© Adriamycin PFS Patient Information is supplied by Cerner Multum, Inc. and Adriamycin PFS Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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