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Cosmegen Side Effects

Generic Name: dactinomycin

Medically reviewed by Drugs.com. Last updated on June 10, 2020.

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

For the Consumer

Applies to dactinomycin: intravenous powder for solution

Side effects requiring immediate medical attention

Along with its needed effects, dactinomycin (the active ingredient contained in Cosmegen) 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 dactinomycin:

More common

  • Black, tarry stools
  • blood in the urine or stools
  • chills
  • cough
  • diarrhea (continuing)
  • difficulty with swallowing
  • fever
  • heartburn
  • hoarseness
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on the skin
  • sores in the mouth and on the lips
  • stomach pain (continuing)
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • body aches or pain
  • chapped, red, or swollen lips
  • confusion
  • congestion
  • cough
  • difficulty with breathing
  • difficulty with moving
  • difficulty with swallowing
  • dryness or soreness of the throat
  • flushing or redness of the skin
  • irregular heartbeat
  • joint pain or swelling
  • muscle ache, pains, or stiffness
  • muscle cramps in the hands, arms, feet, legs, or face
  • numbness and tingling around the mouth, fingertips, or feet
  • pain at the injection site
  • runny nose
  • scaling, redness, burning, pain, or other signs of inflammation of the lips
  • seizures
  • slow growth
  • stomach cramps
  • swelling of the feet or lower legs
  • tender, swollen glands in the neck
  • tremor
  • unusually warm skin
  • voice changes
  • yellow eyes or skin

Side effects not requiring immediate medical attention

Some side effects of dactinomycin 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

  • Darkening of the skin
  • general feeling of discomfort or weakness
  • nausea
  • skin rash or acne
  • unusual feeling of dullness or sluggishness
  • vomiting

For Healthcare Professionals

Applies to dactinomycin: intravenous powder for injection

Gastrointestinal

Frequency not reported: Proctitis, cheilitis, dysphagia, esophagitis, ulcerative stomatitis, nausea, vomiting, abdominal pain, diarrhea, GI ulceration, nausea, vomiting[Ref]

Hepatic

Frequency not reported: Liver function test abnormalities, ascites, hepatomegaly, hepatitis, hepatic failure, hepatic veno-occlusive disease (VOD)[Ref]

Hematologic

Frequency not reported: Anemia, aplastic anemia, agranulocytosis, leukopenia, neutropenia, febrile neutropenia, thrombocytopenia, pancytopenia, reticulocytopenia, disseminated intravascular coagulation[Ref]

Dermatologic

Frequency not reported: Alopecia, skin eruptions, acne, erythema multiforme, flare-up of erythema, increased pigmentation of previously irradiated skin

Postmarketing reports: Toxic epidermal necrolysis (TEN), Stevens Johnson Syndrome (SJS)[Ref]

Local

Very rare (less than 0.01%): Contracture of the arms

Frequency not reported: Extravasation, severe damage to soft tissue, epidermolysis, erythema, edema[Ref]

Metabolic

Frequency not reported: Hypocalcemia, anorexia, hypocalcemia, tumor lysis syndrome (TLS)[Ref]

Musculoskeletal

Frequency not reported: Myalgia, growth retardation[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Cardiovascular

Postmarketing reports: Thrombophlebitis, hemorrhage[Ref]

Oncologic

Frequency not reported: Secondary malignancy (e.g., leukemia)[Ref]

Immunologic

Frequency not reported: Sepsis (e.g., neutropenic sepsis), infection[Ref]

Ocular

Frequency not reported: Optic neuropathy[Ref]

Respiratory

Frequency not reported: Pharyngitis, pneumonitis

Postmarketing reports: Pneumothorax[Ref]

Other

Frequency not reported: Malaise, fatigue, lethargy, fever, radiation toxicity, radiation recall[Ref]

Nervous system

Frequency not reported: Peripheral neuropathy[Ref]

Renal

Frequency not reported: Renal toxicity

Postmarketing reports: Renal failure[Ref]

References

1. "Product Information. Cosmegen (dactinomycin)." Merck & Co, Inc, West Point, PA.

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.