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Adriamycin PFS

Last reviewed on RxList: 9/11/2008
Adriamycin PFS Side Effects Center

Last reviewed on RxList 02/16/2017

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:

  • nausea and vomiting (may be severe),
  • diarrhea,
  • loss of appetite,
  • missed menstrual periods,
  • darkening of your skin or nails,
  • weakness,
  • tiredness,
  • eye redness, or
  • puffy eyelids.

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 any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • pain, burning, irritation, or skin changes where the injection was given;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain (especially in your face and midsection);
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fast, slow, or uneven heartbeats;
  • anxiety, sweating, severe shortness of breath, wheezing, gasping for breath;
  • chest pain, sudden cough, cough with foamy mucus, rapid breathing, coughing up blood;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth, weak pulse, overactive reflexes, confusion, fainting;
  • muscle weakness, tightness, or contraction;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects may include:

  • missed menstrual periods;
  • darkening of your skin or nails;
  • temporary hair loss;
  • feeling weak or tired;
  • mild nausea, diarrhea; or
  • eye redness, puffy eyelids.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. 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

Dose limiting toxicities of therapy are myelosuppression and cardiotoxicity. Other reactions reported are:

Cardiotoxicity - (See WARNINGS.)

Cutaneous- Reversible complete alopecia occurs in most cases. Hyperpigmentation of nailbeds and dermal creases, primarily in pediatric patients, and onycholysis have been reported in a few cases. Radiation recall reaction has occurred with doxorubicin administration. Rash, itching, or photosensitivity may occur.

Gastrointestinal-Acute nausea and vomiting occurs frequently and may be severe. This may be alleviated by antiemetic therapy. Mucositis (stomatitis and esophagitis) may occur within 5 to 10 of beginning therapy, and most patients recover from this adverse event within another 5 to 10 days. The effect may be severe leading to ulceration and represents a site of origin for severe infections. The dosage regimen consisting of administration of doxorubicin on three successive days results in greater incidence and severity of mucositis. Ulceration and necrosis of the colon, especially the cecum, may occur leading to bleeding or severe infections which can be fatal. This reaction has been reported in patients with acute non-lymphocytic leukemia treated with a 3-day course of doxorubicin combined with cytarabine. Anorexia, abdominal pain, dehydration, diarrhea, and hyperpigmentation of the oral mucosa have been occasionally reported.

Hematologic - (See WARNINGS.)

Hypersensitivity - Fever, chills and urticaria have been reported occasionally. Anaphylaxis may occur. A case of apparent cross sensitivity to lincomycin has been reported.

Neurological- Peripheral neurotoxicity in the form of local-regional sensory and/or motor disturbances have been reported in patients treated intra-arterially with doxorubicin, mostly in combination with cisplatin. Animal studies have demonstrated seizures and coma in rodents and dogs treated with intra-carotid doxorubicin. Seizures and coma have been reported in patients treated with doxorubicin in combination with cisplatin or vincristine.

Ocular - Conjunctivitis, keratitis, and lacrimation occur rarely.

Other - Malaise/asthenia have been reported.

Adverse Reactions in Patients with Early Breast Cancer Receiving Doxorubicin-Containing Adjuvant Therapy: Safety data were collected from approximately 2300 women who participated in a randomized, open-label trial (NSABP B-15) evaluating the use of AC versus CMF in the treatment of early breast cancer involving axillary lymph nodes. In the safety analysis, the follow-up data from all patients receiving AC were combined (N=1492 evaluable patients) and compared with data from patients receiving conventional CMF (i.e., oral cyclophosphamide; N=739 evaluable patients). The most relevant adverse events reported in this study are provided in Table 2.

Table 2. Relevant Adverse Events in Patients with Early Breast Cancer Involving Axillary Lymph Nodes

  AC* Conventional CMF
  N=1492 N=739
Treatment administration
  Mean number of cycles 3.8 5.5
  Total cycles 5676 4068
Adverse events, % of patients
  Leukopenia    
  Grade 3 (1,000-1,999 /mm3) 3.4 9.4
  Grade 4 (<1000 /mm3) 0.3 0.3
Thrombocytopenia
  Grade 3 (25,000-49,999 /mm3) 0 0.3
  Grade 4 (<25,000 /mm3) 0.1 0
  Shock, sepsis 1.5 0.9
  Systemic infection 2.4 1.2
Nausea and vomiting
  Nausea only 15.5 42.8
  Vomiting ≤ 12 hours 34.4 25.2
  Vomiting >12 hours 36.8 12.0
  Intractable 4.7 1.6
  Alopecia 92.4 71.4
  Partial 22.9 56.3
  Complete 69.5 15.1
Weight loss
  5-10% 6.2 5.7
  >10% 2.4 2.8
Weight gain
  5-10% 10.6 27.9
  >10% 3.8 14.3
Cardiac function
  Asymptomatic 0.2 0.1
  Transient 0.1 0
  Symptomatic 0.1 0
  Treatment-related death 0 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

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

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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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