Cosmegen Side Effects Center

Last updated on RxList: 5/19/2022
Cosmegen Side Effects Center

What Is Cosmegen?

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.

What Are Side Effects of Cosmegen?

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

Dosage for Cosmegen

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.

What Drugs, Substances, or Supplements Interact with Cosmegen?

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.

Cosmegen During Pregnancy or Breastfeeding

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.

Additional Information

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.


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Cosmegen Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • swelling or tenderness in your stomach (upper right side), rapid weight gain;
  • swelling in your arms or legs;
  • dark urine, jaundice (yellowing of the skin or eyes);
  • redness of your skin or the inside of your mouth and throat (if you are also receiving radiation treatment);
  • sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
  • blisters, ulcers, or other skin changes where an injection was given; or
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

  • hair loss;
  • fever, infections, low blood cell counts;
  • rash;
  • trouble swallowing;
  • nausea, vomiting; or
  • tiredness.

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 Professional Information


The following serious adverse reactions are described elsewhere in the labeling:

  • Secondary Malignancy and Leukemia [see WARNINGS AND PRECAUTIONS]
  • Veno-occlusive Disease [see WARNINGS AND PRECAUTIONS]
  • Extravasation [see WARNINGS AND PRECAUTIONS]
  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Immunizations [see WARNINGS AND PRECAUTIONS]
  • Severe Mucocutaneous Reactions [see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Potentiation of Radiation Toxicity and Radiation Recall [see WARNINGS AND PRECAUTIONS]

Common adverse reactions are: infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, and hepatotoxicity.

The following adverse reactions have been identified in clinical studies or postmarketing reports. Because some of these reactions were 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.

Infections: infections including sepsis with fatal outcome

Hematologic: anemia, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia, neutropenia, febrile neutropenia, disseminated intravascular coagulation

Immune system: hypersensitivity

Metabolism and nutrition: anorexia, hypocalcemia, tumor lysis syndrome

Nervous system: peripheral neuropathy

Ocular: optic neuropathy

Vascular: thrombophlebitis, hemorrhage Respiratory, thoracic and mediastinal: pneumonitis, pneumothorax

Gastrointestinal: nausea, vomiting, abdominal pain, diarrhea, constipation, gastrointestinal ulceration, cheilitis, dysphagia, esophagitis, ulcerative stomatitis, ascites, proctitis, mucositis

Hepatobiliary: liver function test abnormalities, hepatomegaly, hepatitis, hepatic failure with reports of death, hepatic veno-occlusive disease

Dermatologic: alopecia, rash, dermatitis, acne, erythema multiforme, Stevens Johnson Syndrome, radiation recall, toxic epidermal necrolysis Musculoskeletal and connective tissue: myalgia, growth retardation

Renal and urinary: renal impairment, renal failure

General: fatigue, fever, malaise


No Information Provided

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

© 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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