Leuprolide / Norethindrone Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 15, 2024.

Applies to leuprolide / norethindrone: powder for suspension 1 month, powder for suspension 3 month, tablet.

Precautions

It is very important that your doctor check the your progress at regular visits to make sure that this medicine is working properly.

You should not receive this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control (eg, diaphragm with spermicide, condoms with spermicide, IUD) to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine can cause your bone mineral density to decrease, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.

Using this medicine may increase your risk of having seizures. Check with your doctor right away if you start to have muscle spasm or jerking of the arms or legs, sudden loss of consciousness, or loss of bladder control.

This medicine may cause depression. Check with your doctor right away if you have discouragement, feeling sad or empty, irritability, lack or appetite, loss of interest or pleasure, tiredness, trouble concentrating, or trouble sleeping.

Call your doctor right away if you have sudden loss of vision, double vision, bulging eyes, or a migraine headache.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects

Along with its needed effects, leuprolide/norethindrone 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 leuprolide / norethindrone:

Other side effects

Some side effects of leuprolide / norethindrone 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 healthcare professionals

Applies to leuprolide / norethindrone: oral and injectable kit.

General adverse events

The most common adverse reactions leading to discontinuation of therapy included hot flashes (4%), emotional lability (4%), depression (4%) and acne (2%).

The most common adverse reaction observed were hot flashes and headaches.^[Ref]

Cardiovascular

Leuprolide-Norethindrone:

• Very common (10% or more): Hot flashes/sweats (up to 87%)

Leuprolide:

• Very common (10% or more): Hot flashes/sweats (98%)
• Postmarketing reports: Hypotension, hypertension, serious venous and arterial thrombotic and thromboembolic events (deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack^[Ref]

Dermatologic

Leuprolide-Norethindrone:

• Very common (10% or more): Androgen-like effects (acne, alopecia) (up to 18%), skin/mucous membrane reaction (up to 11%)

Leuprolide:

• Common (1% to 10%): Androgen-like effects (acne, alopecia) (4%), skin/mucous membrane reaction (4%)^[Ref]

Gastrointestinal

Leuprolide-Norethindrone:

• Very common (10% or more): Altered bowel function (constipation, diarrhea) (up to 15%), nausea/vomiting (up to 29%)
• Common (1% to 10%): GI disturbances (dyspepsia, flatulence) (up to 7%), changes in appetite (6%)

Leuprolide:

• Very common (10% or more): Nausea/vomiting (25%), altered bowel function (constipation, diarrhea) (14%)
• Common (1% to 10%): Changes in appetite (4%)%), GI disturbances (dyspepsia, flatulence) (4%)^[Ref]

Genitourinary

Leuprolide-Norethindrone:

• Very common (10% or more): Vaginitis (up to 15%%), breast changes/pain/tenderness (up to 13%)
• Common (1% to 10%): Menstrual disorders (5%)
• Frequency not reported: Urinary tract infection

Leuprolide:

• Very common (10% or more): Vaginitis (20%)
• Common (1% to 10%): Breast changes/pain/tenderness (6%), menstrual disorders (2%)^[Ref]

Hematologic

Leuprolide:

• Postmarketing reports: Decreased white blood count^[Ref]

Hepatic

Leuprolide:

• Postmarketing reports: Serious liver injury

Leuprolide-Norethindrone:

• Common (1% to 10%): Elevated SGPT (at least twice the upper limit) (2%), elevated GGT (1.5%)^[Ref]

Hypersensitivity

Leuprolide-Norethindrone:

• Postmarketing reports: Allergic reactions (anaphylactic, rash, urticaria, photosensitivity)^[Ref]

Local

Leuprolide-Norethindrone:

• Common (1% to 10%): Injection site reaction (up to 9%)

Leuprolide:

• Common (1% to 10%): Injection site reaction (2%)
• Postmarketing reports: Localized reactions including induration and abscess at the site of injection^[Ref]

Metabolic

Leuprolide-Norethindrone:

• Very common (10% or more): Weight gain (up to 13%)
• Common (1% to 10%): Edema (up to 9%), elevated SGPT (at least twice the upper limit) (2%), elevated GGT (1.5%)
• Frequency not reported: Increased total cholesterol (greater than 240 mg/dL), decreased HDL cholesterol (less than 40 mg/dL), increased LDL cholesterol (greater than 160 mg/dL), increased LDL/HDL ratio (greater than 4), increased triglycerides (greater than 200 mg/dL)

Leuprolide:

• Common (1% to 10%): Weight gain (12%)^[Ref]

Musculoskeletal

Leuprolide:

• Postmarketing reports: Spinal fracture, tenosynovitis-like symptoms, symptoms consistent with fibromyalgia^[Ref]

Nervous system

Leuprolide-Norethindrone:

• Very common (10% or more): Headache/migraine (up to 51%), insomnia/sleep disorders (up to 15%), dizziness/vertigo (up to 11%)
• Common (1% to 10%): Neuromuscular disorder (leg cramps, paraesthesia) (up to 9%), decreased libido (up to 7%), memory disorder (up to 4%)

Leuprolide:

• Very common (10% or more): Headache/migraine (65%), insomnia/sleep disorders (31%), dizziness/vertigo (16%), decreased libido (10%)
• Common (1% to 10%): Memory disorder (6%), neuromuscular disorder (leg cramps, paraesthesia) (2%)
• Postmarketing reports: Pituitary apoplexy, convulsion, peripheral neuropathy, paralysis^[Ref]

Other

Leuprolide-Norethindrone:

• Very common (10% or more): Pain (up to 29%), asthenia (up to 18%)

Leuprolide:

• Very common (10% or more): Pain (24%), asthenia (18%)

Psychiatric

Leuprolide-Norethindrone:

• Very common (10% or more): Depression/emotional lability (up to 34%), nervousness/anxiety (up to 11%)

Leuprolide:

• Very common (10% or more): Depression/emotional lability (31%)
• Common (1% to 10%): Nervousness/anxiety (8%)
• Postmarketing reports: Mood swings, suicidal ideation and attempt^[Ref]

Renal

Leuprolide-Norethindrone:

• Frequency not reported: Renal calculus^[Ref]

Respiratory

Leuprolide:

• Postmarketing reports: Symptoms consistent with an asthmatic process^[Ref]

See also:

Further information

Leuprolide/norethindrone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer