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Firmagon Side Effects

Generic Name: degarelix

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

For the Consumer

Applies to degarelix: subcutaneous powder for solution

Along with its needed effects, degarelix (the active ingredient contained in Firmagon) 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 degarelix:

More Common

  • Back pain
  • blurred vision
  • dizziness
  • fever
  • flushing or redness of the skin
  • hard lump
  • headache
  • nervousness
  • pain
  • pounding in the ears
  • slow or fast heartbeat
  • small lumps under the skin
  • swelling
  • unusually warm skin

Less Common

  • Bladder pain
  • bloody or cloudy urine
  • chills
  • decrease in testicle size
  • decreased interest in sexual intercourse
  • difficult, burning, or painful urination
  • difficulty in moving
  • frequent urge to urinate
  • inability to have or keep an erection
  • increased sweating
  • loss in sexual ability, desire, drive, or performance
  • lower back or side pain
  • muscle pain or stiffness
  • pain in the joints

Rare

Some side effects of degarelix 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

  • Difficulty having a bowel movement (stool)
  • feeling of warmth
  • increased weight
  • redness of the face, neck, arms, and occasionally, upper chest
  • sudden sweating
  • unusual tiredness or weakness

Less Common

For Healthcare Professionals

Applies to degarelix: subcutaneous powder for injection

Hepatic

Very common (10% or more): Increased liver transaminases (47%), increased gamma-glutamyltransferase (10%)

Uncommon (0.1% to 1%): Increased bilirubin, increased alkaline phosphatase[Ref]

Other

Very common (10% or more): Injection site reaction (including pain, erythema, swelling, induration, nodule; 44%), pyrexia (10%), fatigue (10%)

Common (1% to 10%): Chills, asthenia, influenza-like illness[Ref]

Hematologic

Very common (10% or more): Decreased hematocrit (40%), decreased hemoglobin (15%)

Common (1% to 10%): Anemia

Rare (less than 0.1%): Neutropenic fever[Ref]

Cardiovascular

Very common (10% or more): Hot flush (26%), QT/QTc interval prolongation (20%)

Common (1% to 10%): Hypertension

Uncommon (0.1% to 1%): Cardiac arrhythmia (including atrial fibrillation), palpitations, vasovagal reaction (including hypotension)

Rare (less than 0.1%): Myocardial infarction, cardiac failure[Ref]

Renal

Very common (10% or more): Abnormal BUN (15%)

Common (1% to 10%): Abnormal creatinine level

Uncommon (0.1% to 1%): Renal impairment[Ref]

Metabolic

Very common (10% or more): Increased weight (11%), decreased weight (10%)

Common (1% to 10%): Abnormal potassium level

Uncommon (0.1% to 1%): Hyperglycemia/diabetes mellitus, increased cholesterol, decreased appetite, blood calcium changes[Ref]

Immunologic

Very common (10% or more): Antibody formation (10%)[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis (including night sweats), rash

Uncommon (0.1% to 1%): Urticaria, skin hyperpigmentation, skin nodule, alopecia, pruritus, erythema[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, constipation, diarrhea

Uncommon (0.1% to 1%): Vomiting, abdominal pain, abdominal discomfort, dry mouth[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, gynecomastia, testicular atrophy, erectile dysfunction

Uncommon (0.1% to 1%): Pollakiuria, micturition urgency, dysuria, nocturia, incontinence, testicular pain, breast pain, pelvic pain, genital irritation, ejaculation failure[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, musculoskeletal pain and discomfort

Uncommon (0.1% to 1%): Osteoporosis/osteopenia, arthralgia, muscular weakness, muscle spasms, joint swelling/stiffness[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Mental impairment, hypoesthesia[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Loss of/decreased libido, depression[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reaction

Postmarketing reports: Anaphylaxis, angioedema[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Firmagon (degarelix)." Ferring Pharmaceuticals Inc, Tarrytown, NY.

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.

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