Alora
- Generic Name: estradiol transdermal system
- Brand Name: Alora
Alora (Estradiol Transdermal System) side effects drug center
Alora Side Effects Center
What Is Alora?
Alora (estradiol transdermal system) is a form of estrogen, a female sex hormone, used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Alora also reduces urgency or irritation of urination. Alora skin patches are also used to treat ovarian disorders, infertility, and abnormal vaginal bleeding. Some estradiol skin patches are used to prevent postmenopausal osteoporosis.
What Are Side Effects of Alora?
Common side effects of Alora include:
- skin redness or irritation at the application site,
- nausea,
- vomiting,
- upset stomach,
- bloating,
- constipation,
- breast swelling and tenderness,
- nipple discharge,
- headache,
- weight changes,
- acne or skin color changes,
- increased facial hair,
- thinning scalp hair,
- back pain,
- joint pain,
- cold symptoms (stuffy nose, sneezing, sinus pain, sore throat),
- changes in your menstrual periods, or
- break-through bleeding.
Tell your doctor if you have serious side effects of Alora including:
- chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, sudden vision changes, problems with speech or balance;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- pain, swelling, or tenderness in your stomach;
- jaundice (yellowing of the skin or eyes);
- a lump in your breast;
- numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Dosage for Alora
Alora should be administered twice weekly, as instructed. The adhesive side of the Alora system should be placed on a clean, dry area of skin, usually on the lower abdomen.
What Drugs, Substances, or Supplements Interact with Alora?
Alora may interact with St. John's wort, phenobarbital, blood thinners, ritonavir, carbamazepine, antibiotics, or antifungal medications. Tell your doctor all medications and supplements you use.
Alora During Pregnancy and Breastfeeding
Alora must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding.
Additional Information
Our Alora (estradiol transdermal system) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Alora Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Remove the skin patch and call your doctor at once if you have:
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
- signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
- swelling or tenderness in your stomach;
- jaundice (yellowing of the skin or eyes);
- unusual vaginal bleeding, pelvic pain;
- a breast lump;
- memory problems, confusion, unusual behavior; or
- high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.
Common side effects may include:
- headache, back pain;
- stuffy nose, sinus pain, sore throat;
- vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
- bloating, stomach cramps, nausea, vomiting;
- breast pain;
- redness or irritation where the patch was worn;
- thinning scalp hair; or
- fluid retention (swelling, rapid weight gain).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Alora (Estradiol Transdermal System)
Alora Professional Information
SIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOXED WARNING and WARNINGS AND PRECAUTIONS].
- Malignant Neoplasms [see BOXED WARNING and WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions for Alora 0.025 mg/day, 0.05 mg/day, and 0.075 mg/day transdermal systems versus placebo, each applied twice weekly, were evaluated in a 2-year randomized, parallel-group, double-blind, double-dummy, placebo-controlled multicenter trial for the prevention of osteoporosis in 355 hysterectomized postmenopausal women [see Clinical Studies]. Adverse reactions with an incidence greater than 2% and greater than placebo, are shown in Table 1
Table 1 : Adverse Reactions for Alora 0.025 mg/day, 0.05 mg/day, and 0.075 mg/day Transdermal Systems, Occurring at Greater than 2% (and greater than Placebo) in a Two-Year Prevention of Osteoporosis Trial (data are expressed as N and (%) of treatment group).
| Body System | Placebo (N = 87) | Alora 0.025 mg/day (N = 89) | Alora 0.05 mg/day (N = 90) | Alora 0.075 mg/day (N = 89) |
| Preferred Term | n (%) | n (%) | n (%) | n (%) |
| Body As A Whole | ||||
| Asthenia | 4 (4.6) | 7 (7.9) | -- | -- |
| Cyst | 3 (3.4) | -- | 6 (6.7) | -- |
| Infection Fungal | 1 (11) | 3 (3.4) | 9 (10) | 4 (4.5) |
| Pain Abdominal | 4 (4.6) | 7 (7.9) | 5 (5.6) | -- |
| Pain Back | 5 (5.7) | -- | -- | 7 (7.9) |
| Cardiovascular Hypertension Migraine | 3 (3.4) 2 (2.3) | 6 (6.7) | -- | 6 (6.7) |
| Digestive | ||||
| Dyspepsia | 1 (11) | 8 (9) | 4 (4.4) | 3 (3.4) |
| Gastroenteritis | 2 (2.3) | 3 (3.4) | 4 (4.4) | 3 (3.4) |
| Nausea | 3 (3.4) | 6 (6.7) | 5 (5.6) | -- |
| Nervous | ||||
| Dizziness | 0 (0) | -- | 7 (7.8) | 4 (4.5) |
| Skin | ||||
| Hirsutism | 0 (0) | 2 (2.2) | 2 (2.2) | 4 (4.5) |
| Pruritus | 4 (4.6) | -- | -- | 6 (6.7) |
| Rash | 5 (5.7) | 6 (6.7) | 8 (8.9) | -- |
| Urogenital | ||||
| Breast Enlargement | 3 (3.4) | -- | -- | 6 (6.7) |
| Leukorrhea | 1 (11) | 3 (3.4) | 2 (2.2) | 4 (4.5) |
| Pain Breast | 7 (8) | 13 (14.6) | 16 (17.8) | 31 (34.8) |
| --represents exclusion of data that was less than 2% or less than placebo. | ||||
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Alora. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Genitourinary system: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, dysmenorrhea, metrorrhagia, menorrhagia, amenorrhea, vaginitis, including vaginal candidiasis, vulvovaginal dryness, vulvovaginal pruritus, endometrial cancer.
Breast: Pain, tenderness, enlargement, swelling, breast cancer, nipple pain, galactorrhea.
Cardiovascular: Hot flushes, palpitations, tachycardia, increase in blood pressure, deep venous thrombosis, pulmonary embolism.
Gastrointestinal: Nausea, vomiting, abdominal pain, abdominal distention, flatulence, diarrhea, gallbladder disease, pancreatitis.
Skin: Rash, pruritus, alopecia, erythema nodosum, hemorrhagic eruption, hyperhidrosis, hirsutism, application site reaction.
Eyes: Blurred vision, visual impairment.
Central nervous system: Headache, migraine, dizziness, insomnia, anxiety, mental depression, nervousness, mood swings, irritability, hypoaesthesia, paresthesia, somnolence, loss of libido.
Miscellaneous: Increase or decrease in weight, reduced carbohydrate tolerance, arthalgias, back pain, increased triglycerides, increased cholesterol, exacerbation of asthma, vertigo.
Read the entire FDA prescribing information for Alora (Estradiol Transdermal System)
&Copy; Alora Patient Information is supplied by Cerner Multum, Inc. and Alora Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.