Lopreeza Side Effects
Generic name: estradiol / norethindrone
Medically reviewed by Drugs.com. Last updated on May 27, 2024.
Note: This document provides detailed information about Lopreeza Side Effects associated with estradiol / norethindrone. Some dosage forms listed on this page may not apply specifically to the brand name Lopreeza.
Applies to estradiol / norethindrone: oral tablet.
Other dosage forms:
Important warnings
This medicine can cause some serious health issues
Serious side effects of Lopreeza
Along with its needed effects, estradiol/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 immediately if any of the following side effects occur while taking estradiol / norethindrone:
More common side effects
- body aches or pain
- chills or fever
- cold or flu-like symptoms
- difficulty breathing
- headache
- itching of the vagina or genital area
- non-menstrual vaginal bleeding
- pain during sexual intercourse
- thick, white vaginal discharge with no odor or with a mild odor
- unusual tiredness or weakness
Incidence not known
- blistering, peeling, or loosening of the skin
- breast tenderness
- change in vaginal discharge
- change in vision
- chest pain, discomfort, or tightness
- clay-colored stools
- clear or bloody discharge from the nipple
- confusion
- dark urine
- difficulty speaking
- difficulty swallowing
- dizziness or lightheadedness
- double vision
- fainting
- fast heartbeat
- inability to move the arms, legs, or facial muscles
- inability to speak
- joint or muscle pain
- loss of appetite
- lump in the breast or under the arm
- nausea and vomiting
- noisy breathing
- pain in the ankles or knees
- pain or discomfort in the arms, jaw, back, or neck
- pain or feeling of pressure in the pelvis
- pain, redness, or swelling in the arm or leg
- painful, red lumps under the skin, mostly on the legs
- pains in the stomach, side, or abdomen, possibly radiating to the back
- problems with memory or speech
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- redness or swelling of the breast
- skin rash, hives, or itching
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain
- sweating
- trouble breathing
- trouble recognizing objects
- trouble thinking and planning
- trouble walking
- unexpected or excess milk flow from the breasts
Other side effects of Lopreeza
Some side effects of estradiol / 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:
More common side effects
- back pain
- cramps
- crying
- euphoria
- mental depression
- paranoia
- quick to react or overreact emotionally
- rapidly changing moods
- trouble sleeping
- weakness
- weight gain
Incidence not known
- changes in appetite
- changes in sexual ability, desire, drive, or performance
- excess air or gas in the stomach or intestines
- increased hair growth, especially on the face
- patchy brown or dark brown discoloration of the skin
- trouble wearing contact lenses
For healthcare professionals
Applies to estradiol / norethindrone: oral tablet, transdermal film extended release.
General adverse events
The most common adverse events were vaginal bleeding and breast pain/tenderness. Vaginal bleeding usually occurred in the first months of treatment. Breast pain usually disappeared after a few months of therapy.[Ref]
Genitourinary
- Very common (10% or more): Vaginal hemorrhage (26%), breast pain (24%), post-menopausal bleeding (11%), endometrial thickening (10%), breast tenderness, menstruation irregular
- Common (1% to 10%): Ovarian cyst, uterine fibroid, breast edema, breast enlargement, uterine fibroids aggravated, uterine fibroids recurrence, uterine fibroids
- Uncommon (0.1% to 1%): Endometrial hyperplasia, dysmenorrhea
- Rare (less than 0.1%): Fallopian tube cysts, endocervical polyps
- Postmarketing reports: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, increase in size of uterine leiomyomata, change in amount of cervical secretion, changes in cervical ectropion, pre-menstrual-like syndrome, cystitis-like syndrome, nipple discharge, galactorrhea, fibrocystic breast changes, vulvovaginal pruritus[Ref]
Nervous system
- Very common (10% or more): Headache (22%)
- Common (1% to 10%): Migraine or migraine aggravated, dizziness
- Rare (less than 0.1%): Paresthesia
- Postmarketing reports: Dizziness, exacerbation of epilepsy, dementia, chorea, stroke[Ref]
Cardiovascular
- Common (1% to 10%): Blood pressure increase
- Uncommon (0.1% to 1%): Thrombophlebitis superficial, venous thromboembolism
- Rare (less than 0.1%): Thrombophlebitis deep, deep venous thromboembolism
- Postmarketing reports: Deep and superficial vein thrombosis, thrombophlebitis, myocardial infarction, stroke, hypertension aggravated[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (11%)
- Common (1% to 10%): Gastroenteritis, diarrhea, abdominal pain, abdominal distention, abdominal discomfort
- Uncommon (0.1% to 1%): Flatulence, bloating
- Postmarketing reports: Vomiting, abdominal cramps, pancreatitis, dyspepsia[Ref]
Psychiatric
- Common (1% to 10%): Insomnia, emotional lability, depression or depression aggravated
- Uncommon (0.1% to 1%): Nervousness, changes in libido
- Postmarketing reports: Mental depression, mood disturbances, irritability, anxiety[Ref]
Other
- Very common (10% or more): Accidental injury (17%)
- Common (1% to 10%): Weight increase, weight decreased, edema peripheral, pain, asthenia
- Uncommon (0.1% to 1%): Drug ineffective
- Postmarketing reports: Fatigue, edema[Ref]
Musculoskeletal
- Very common (10% or more): Back pain (10%)
- Common (1% to 10%): Pain in extremity, leg cramps[Ref]
Immunologic
- Very common (10% or more): Nasopharyngitis (21%), upper respiratory tract infection (18%), sinusitis (15%)
- Common (1% to 10%): Infection viral, moniliasis genital, genital candidiasis or vaginitis[Ref]
Dermatologic
- Common (1% to 10%): Acne, rash, pruritus, dry skin
- Uncommon (0.1% to 1%): Alopecia, hirsutism, urticaria, skin reactions, skin discoloration
- Postmarketing reports: Chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, seborrhea, skin rash, seborrhea, angioneurotic edema[Ref]
Oncologic
- Uncommon (0.1% to 1%): Breast cancer
- Rare (less than 0.1%): Uterine leiomyoma
- Postmarketing reports: Ovarian cancer, endometrial cancer[Ref]
Hypersensitivity
- Uncommon (0.1% to 1%): Hypersensitivity
- Rare (less than 0.1%): Allergic reaction
- Postmarketing reports: Anaphylactoid/anaphylactic reactions[Ref]
Respiratory
- Rare (less than 0.1%): Pulmonary embolism, asthma
- Postmarketing reports: Exacerbation of asthma[Ref]
Hepatic
- Uncommon (0.1% to 1%): Gallbladder disease, gallstones, transaminases increased
- Rare (less than 0.1%): Cholelithiasis
- Postmarketing reports: Cholestatic jaundice, gallbladder disease, cholelithiasis aggravated, cholelithiasis recurrence[Ref]
Metabolic
- Common (1% to 10%): Fluid retention
- Postmarketing reports: Changes in appetite, increased triglycerides[Ref]
Ocular
- Postmarketing reports: Retinal vascular thrombosis, intolerance to contact lenses, visual disturbances[Ref]
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2017) "Product Information. Activella (estradiol-norethindrone)." Gemini Laboratories
4. (2017) "Product Information. Lopreeza (estradiol-norethindrone)." Amneal Pharmaceuticals
5. (2017) "Product Information. Mimvey (estradiol-norethindrone)." Teva Pharmaceuticals USA
6. (2017) "Product Information. Amabelz (estradiol-norethindrone)." Lupin Pharmaceuticals Inc
More about Lopreeza (estradiol / norethindrone)
- Check interactions
- Compare alternatives
- Drug images
- Dosage information
- During pregnancy
- Drug class: sex hormone combinations
Patient resources
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Professional resources
Other brands
CombiPatch, Activella, Mimvey, Amabelz, Etyqa
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Further information
Lopreeza 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.
Some side effects may not be reported. You may report them to the FDA.