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Camcevi Side Effects

Generic name: leuprolide

Medically reviewed by Drugs.com. Last updated on Aug 25, 2022.

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

Applies to leuprolide: emulsion, powder for suspension 1 month, powder for suspension 3 month, powder for suspension 4 month, powder for suspension 6 month, solution.

Serious side effects of Camcevi

Along with its needed effects, leuprolide (the active ingredient contained in Camcevi) 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 immediately if any of the following side effects occur while taking leuprolide:

For adults

Less common

Rare

  • Bone, muscle, or joint pain
  • chest tightness
  • fainting
  • fast or irregular breathing
  • numbness or tingling of the hands or feet
  • puffiness or swelling of the eyelids or around the eyes
  • skin rash, hives, or itching
  • sudden, severe decrease in blood pressure and collapse
  • trouble breathing

For males only (adults)

More common

  • Arm, back, or jaw pain
  • bloody or cloudy urine
  • blurred vision
  • bone pain
  • chest pain or discomfort
  • difficult, burning, or painful urination
  • difficulty with moving
  • dizziness
  • frequent urge to urinate
  • headache
  • increased urge to urinate during the night
  • muscle pain or stiffness
  • nausea
  • nervousness
  • pain in the arms or legs
  • pain in the joints
  • pale skin
  • pounding in the ears
  • slow or fast heartbeat
  • sweating
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • waking to urinate at night

Rare

  • Pain in the groin or legs (especially in the calves)

Incidence not known

  • Altered mental status
  • anxiety
  • blurred vision
  • burning, numbness, tingling, or painful sensations
  • chest pain
  • cold, clammy, pale skin
  • confusion
  • dizziness or lightheadedness
  • double vision
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • irregular heartbeat
  • loss of consciousness
  • seizures
  • thoughts or attempts at killing oneself
  • unexplained weight loss
  • unsteadiness or awkwardness
  • visual changes
  • weakness in the arms, hands, legs, or feet

For females only (adults)

Rare

  • Anxiety
  • deepening of voice
  • increased hair growth
  • mental depression
  • mood changes

For children

More common

  • Body aches or pain
  • chest tightness
  • chills
  • cough
  • cough producing mucus
  • difficulty in breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • muscle aches
  • noisy breathing
  • pain or redness at the injection site
  • runny or stuffy nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness

Less common

  • Irritability
  • mood or mental changes

Rare

  • Burning, itching, or swelling at the injection site

Incidence not known

  • Blurred vision
  • change in ability to see colors, especially blue or yellow
  • nausea and vomiting
  • seizures
  • severe headache

For females only (children)—expected in first few weeks

Rare

Other side effects of Camcevi

Some side effects of leuprolide 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:

For adults

More common

Less common

  • Bleeding, bruising, burning, itching, pain, redness, or swelling at the injection site
  • decreased interest in sexual intercourse
  • swelling of the feet or lower legs
  • swelling or increased tenderness of the breasts
  • trouble sleeping
  • weight gain

For females only (adults)

More common

  • Light, irregular vaginal bleeding
  • stopping of menstrual periods

Less common

  • Burning, dryness, or itching of the vagina
  • pelvic pain

For males only (adults)

More common

  • Back pain
  • chills
  • constipation
  • cough
  • diarrhea
  • fever
  • general feeling of discomfort or illness
  • loss of appetite
  • pain or discomfort at the injection site
  • redness of the face, neck, arms, and occasionally, upper chest
  • runny nose
  • shivering
  • sore throat
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common

  • Decreased size of the testicles
  • inability to have or keep an erection

Incidence not known

  • Increased sensitivity of the skin to sunlight
  • redness or other discoloration of the skin
  • severe sunburn

For children

More common

  • Constipation
  • feeling of warmth
  • redness of the face, neck, arms and occasionally, upper chest
  • stomach pain

For Healthcare Professionals

Applies to leuprolide: intramuscular kit, intramuscular powder for injection, intramuscular powder for injection extended release, subcutaneous emulsion, subcutaneous implant, subcutaneous kit, subcutaneous powder for injection extended release, subcutaneous solution.

General

The most commonly reported side effects were hot flashes, hyperhidrosis, emotional lability/depression, nausea/vomiting, and pain.[Ref]

Cardiovascular

Very common (10% or more): ECG changes (19%), ischemia (19%), hot flush

Common (1% to 10%): Edema, hypertension, murmur, phlebitis, thrombosis, arrhythmias, angina, myocardial infarction

Frequency not reported: Cardiovascular collapse, palpitations, tachycardia

Postmarketing reports: Deep vein thrombosis, hypotension, pulmonary embolism[Ref]

Dermatologic

Very common (10% or more): Hyperhidrosis (up to 98%), hair loss (18%)

Common (1% to 10%): Alopecia, skin rash, acne, itching, dry skin, ecchymosis, pruritus, photosensitivity, clamminess, night sweats, skin pigmentation, skin reactions, skin/mucous membrane reaction

Frequency not reported: Hair disorder, nail disorder[Ref]

Endocrine

Very common (10% or more): Hot flashes (up to 98%)

Very rare (less than 0.01%): Pituitary apoplexy

Frequency not reported: Androgen-like effect, transient increase in serum testosterone concentrations during the first 2 days of therapy, initial flare of symptoms with management of endometriosis/'flare' phenomenon[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (up to 25%), altered bowel function (up to 14%), constipation (up to 14%), diarrhea (up to 14%)

Common (1% to 10%): dyspepsia, gastroenteritis/colitis, dysphagia, flatulence, gastrointestinal (GI) bleeding, GI disturbance, peptic ulcer, rectal polyps

Frequency not reported: Dry mouth, GI distress[Ref]

Genitourinary

Very common (10% or more): Vaginal dryness (37%), vaginitis (up to 28%), breast tenderness (14%), libido decreased, erectile dysfunction, testicular atrophy

Common (1% to 10%): Breast changes, breast enlargement, breast pain, breast soreness/tenderness, menstrual disorders, urinary frequency/urgency, hematuria, urinary tract infection, ovarian hyperstimulation, testicular soreness/pain, penile disorder, vaginal hemorrhage, gynecomastia, decrease in testicular size, impotence

Frequency not reported: Dysuria, lactation, urinary tract obstruction[Ref]

Hematologic

Common (1% to 10%): Anemia

Frequency not reported: Decreased red blood cell count (RBC)/hematocrit/hemoglobin, thrombocytopenia, leucopenia

Postmarketing reports: Decreased white blood cell count (WBC)[Ref]

Hepatic

Common (1% to 10%): Increased liver enzymes

Frequency not reported: Hepatitis, hepatomegaly, jaundice

Postmarketing reports: Hepatic dysfunction, serious liver injury[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, hypersensitivity reactions

Postmarketing reports: Anaphylactic reactions (e.g., rash, pruritus, urticaria, wheezing or interstitial pneumonitis, anaphylactic reactions)[Ref]

Immunologic

Frequency not reported: Flu syndrome[Ref]

Local

Frequency not reported: Erythema, ecchymosis, induration, abscess, pain, swelling, nodules, ulcers, irritation, necrosis at the site of injection[Ref]

Metabolic

Very common (10% or more): Weight gain/loss (up to 13%)

Common (1% to 10%): Anorexia

Frequency not reported: Appetite changes

Frequency not reported: Thirst

Postmarketing reports: Diabetes[Ref]

Musculoskeletal

Common (1% to 10%): Bone/joint pain, myalgia, ankylosing spondylosis, arthritis, blurred disc margins, bone fracture, joint disorder, leg cramps, muscle stiffness, muscle weakness/tenderness, pelvic fibrosis, spasms/cramps

Uncommon (0.1% to 1%): Myalgia, weakness of lower extremities

Frequency not reported: Backache, muscle atrophy, limb pain, loss of bone mineral density

Postmarketing reports: Joint/muscle pain, spinal fracture/paralysis, tenosynovitis-like symptoms[Ref]

Nervous system

Very common (10% or more): Headache (sometimes severe [up to 65%])), migraine (up to 65%), asthenia (up to 18%), dizziness/lightheadedness (up to 16%), vertigo (up to 16%)

Common (1% to 10%): Memory disorder, neuromuscular disorder, paresthesia

Very rare (less than 0.01%): Pituitary apoplexy (following initial administration in patients with pituitary adenoma)

Frequency not reported: Convulsions, syncope, taste perversion

Postmarketing reports: Peripheral neuropathy, stroke, symptoms consistent with fibromyalgia, sudden headache, transient ischemic attack[Ref]

Ocular

Frequency not reported: Conjunctivitis, ophthalmologic disorders, visual impairment

Postmarketing reports: Ophthalmoplegia, visual changes[Ref]

Other

Very common (10% or more): Pain (up to 24%), general pain (up to 19%)

Common (1% to 10%): Tinnitus, edema peripheral

Frequency not reported: Body odor, disturbance of smell/taste

Postmarketing reports: Hearing disorder[Ref]

Psychiatric

Very common (10% or more): Depression (up to 31%), emotional lability (up to 31%), insomnia/sleep disorder (up to 31%), decreased libido (up to 11%)

Common (1% to 10%): Anxiety, nervousness, mood changes, increased libido

Frequency not reported: Delusions

Postmarketing reports: Altered mental status, suicidal ideation, suicide attempt[Ref]

Renal

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

Respiratory

Common (1% to 10%): Dyspnea, sinus congestion, chest tightness, decreased breathing sounds, hemoptysis, pleuritic chest pain, pulmonary infiltrate, rales/rhonchi, rhinitis, strep throat, wheezing/bronchitis, pulmonary edema, pulmonary embolism

Frequency not reported: Interstitial lung disease (ILD)

Postmarketing reports: Shortness of breath, symptoms consistent with asthmatic process[Ref]

Frequently asked questions

References

1. "Product Information. Lupron (leuprolide)." TAP Pharmaceuticals Inc (2002):

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

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

4. "Product Information. Eligard (leuprolide)." sanofi-aventis (2019):

5. "Product Information. Camcevi (leuprolide)." Accord Biopharma Inc (2022):

6. "Product Information. Fensolvi (leuprolide)." Tolmar Pharmaceuticals (2022):

7. "Product Information. Lupron Depot-Gyn (leuprolide)." TAP Pharmaceuticals Inc (2020):

8. "Product Information. Lupron Depot-Ped (leuprolide)." AbbVie US LLC (2022):

9. "Product Information. Viadur (leuprolide)." Bayer Pharmaceutical Inc (2006):

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.