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Last reviewed on RxList: 3/20/2017
Cosmegen Side Effects Center

Last reviewed on RxList 3/28/2016

Cosmegen (dactinomycin) for Injection is a cancer (antineoplastic) medication used to treat different types of cancers that affect the kidneys, uterus, testicles, bones, muscles, joints, and soft tissues. Cosmegen is also used to treat solid tumors. Cosmegen is available in generic form. Common side effects of Cosmegen include

  • nausea or vomiting (may be severe)
  • stomach pain
  • loss of appetite
  • diarrhea
  • acne
  • pain/redness at the injection site
  • tiredness
  • muscle pain
  • rectal pain or bleeding
  • numbness or tingly feeling around your mouth
  • fast or slow heart rate
  • muscle tightness or contraction
  • overactive reflexes
  • hair loss
  • dry or cracked skin
  • chapped lips, or
  • skin rash

The dosage of Cosmegen varies depending on the tolerance of the patient, the size and location of the tumor, and the use of other forms of therapy. Other drugs may interact with Cosmegen. Tell your doctor all medications and supplements you use. Cosmegen is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. To avoid pregnancy, both males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor to discuss birth control. It is unknown if this drug passes into breast milk. It may have undesirable effects on a nursing infant. Breastfeeding while using Cosmegen is not recommended.

Our Cosmegen (dactinomycin) For Injection 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.

Cosmegen 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.

Call your doctor at once if you have a serious side effect such as:

  • pain, swelling, burning, irritation, or skin changes where the injection was given;
  • fever, chills, body aches, diarrhea, flu symptoms, sores in your mouth and throat;
  • swelling or tenderness in your upper stomach, weight gain, dark urine, jaundice (yellowing of the skin or eyes);
  • feeling short of breath, urinating less than usual or not at all;
  • chest pain, dry cough, wheezing;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • any wound that will not heal; or
  • redness or your skin or the inside of your mouth and throat (if you are also receiving radiation treatment).

Less serious side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;
  • tired feeling, muscle pain;
  • rectal pain or bleeding;
  • numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;
  • hair loss;
  • dry or cracked skin, chapped lips; or
  • acne, mild skin rash.

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 Cosmegen (Dactinomycin for Injection)

Cosmegen Professional Information


Toxic effects (excepting nausea and vomiting) usually do not become apparent until two to four days after a course of therapy is stopped, and may not peak until one to two weeks have elapsed. Deaths have been reported. However, adverse reactions are usually reversible on discontinuance of therapy. They include the following:

Miscellaneous: Sepsis (including neutropenic sepsis) with fatal outcome, infection, malaise, fatigue, lethargy, fever, myalgia, proctitis, hypocalcemia and growth retardation.

Oral: cheilitis, dysphagia, esophagitis, ulcerative stomatitis, pharyngitis.

Lung: pneumonitis.

Gastrointestinal: anorexia, nausea, vomiting, abdominal pain, diarrhea, gastrointestinal ulceration. Nausea and vomiting, which occur early during the first few hours after administration, may be alleviated by the administration of anti-emetics.

Hepatic: liver toxicity including liver function test abnormalities, ascites, hepatomegaly, hepatitis, hepatic failure with reports of death, hepatic veno-occlusive disease which may be associated with intravascular clotting disorder and multi-organ failure (see PRECAUTIONS, Veno-occlusive Disease).

Hematologic: anemia, even to the point of aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia, neutropenia, febrile neutropenia. Platelet and white cell counts should be performed frequently to detect severe hematopoietic depression. If either count markedly decreases, the drug should be withheld to allow marrow recovery. This often takes up to three weeks.

Dermatologic: alopecia, skin eruptions, acne, erythema multiforme, flare-up of erythema or increased pigmentation of previously irradiated skin. Toxic Epidermal Necrolysis (TEN) and Stevens Johnson Syndrome (SJS) have been observed from postmarketing experience.

Soft tissues: Dactinomycin is extremely corrosive. If extravasation occurs during intravenous use, severe damage to soft tissues will occur. In at least one instance, this has led to contracture of the arms. Epidermolysis, erythema, and edema, at times severe, have been reported with regional limb perfusion.

Laboratory Tests

Many abnormalities of renal, hepatic, and bone marrow function have been reported in patients with neoplastic diseases receiving COSMEGEN. Renal, hepatic, and bone marrow functions should be assessed frequently.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or

Read the entire FDA prescribing information for Cosmegen (Dactinomycin for Injection)

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

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