Alora
FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex »
"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Dyspareunia"...
Read the FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sex article »
Alora
Alora Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Alora (estradiol transdermal system) is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. It 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. It is a form of estrogen, a female sex hormone. Common side effects include skin redness/irritation at the application site, nausea/vomiting, bloating, breast tenderness, headache, or weight changes.
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. 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 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. 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.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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Alora in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- pain or swelling in your lower leg;
- abnormal vaginal bleeding;
- pain, swelling, or tenderness in your stomach;
- jaundice (yellowing of the skin or eyes); or
- a lump in your breast.
Less serious side effects may include:
- nausea, vomiting, loss of appetite;
- swollen breasts;
- acne or skin color changes;
- decreased sex drive, impotence, or difficulty having an orgasm;
- migraine headaches or dizziness;
- vaginal pain, dryness, or discomfort;
- swelling of your ankles or feet;
- depression; or
- changes in your menstrual periods, break-through bleeding.
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) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Alora FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
See BOXED WARNINGS, WARNINGS and PRECAUTIONS.
Because clinical trials are conducted under widely varying conditions, adverse reaction 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Incidence of adverse events > 2% of each treatment group is given in Table 5.
Table 5: Incidence of Adverse Events > 2% for Alora (estradiol transdermal system) and
Placebo Systems (data are expressed as N and (%) of treatment group)
| Body System Preferred Term | Placeboa (N=87) |
Alora (estradiol transdermal system) a 0.025 mg/day (N=89) |
Alora (estradiol transdermal system) a 0.05 mg/day (N=90) |
Alora (estradiol transdermal system) a 0.075 mg/day (N=89) |
Alora (estradiol transdermal system) b 0.1 mg/day (N=174) |
| Body As A Whole | |||||
| Accidental Injury | 4 (4.6) | 6 (6.7) | 8 (8.9) | 4 (4.5) | 9 (5.2) |
| Allergic Reaction | 2 (2.3) | 4 (4.5) | 4 (4.4) | 2 (2.2) | 1 (0.6) |
| Asthenia | 4 (4.6) | 7 (7.9) | 4 (4.4) | 0 (0) | 4 (2.3) |
| Cyst | 3 (3.4) | 0 (0) | 6 (6.7) | 3 (3.4) | 0 (0) |
| Flu Syndrome | 9 (10.3) | 8 (9) | 12 (13.3) | 9 (10.1) | 6 (3.4) |
| Headache | 11 (12.6) | 10 (11.2) | 8 (8.9) | 5 (5.6) | 37 (21.3) |
| Infection | 2 (2.3) | 2 (2.2) | 3 (3.3) | 3 (3.4) | 2 (1.1) |
| Infection Fungal | 1 (1.1) | 3 (3.4) | 9 (10) | 4 (4.5) | 0 (0) |
| Pain | 11 (12.6) | 9 (10.1) | 5 (5.6) | 6 (6.7) | 16 (9.2) |
| Pain Abdominal | 4 (4.6) | 7 (7.9) | 5 (5.6) | 1 (1.1) | 5 (2.9) |
| Pain Back | 5 (5.7) | 5 (5.6) | 3 (3.3) | 7 (7.9) | 11 (6.3) |
| Pain Chest | 4 (4.6) | 4 (4.5) | 2 (2.2) | 1 (1.1) | 2 (1.1) |
| Cardiovascular | |||||
| Hypertension | 3 (3.4) | 3 (3.4) | 3 (3.3) | 6 (6.7) | 0 (0) |
| Migraine | 2 (2.3) | 6 (6.7) | 2 (2.2) | 0 (0) | 2 (1.1) |
| Vasodilation | 13 (14.9) | 6 (6.7) | 2 (2.2) | 1 (1.1) | 0 (0) |
| Digestive | |||||
| Constipation | 4 (4.6) | 3 (3.4) | 6 (6.7) | 1 (1.1) | 3 (1.7) |
| Diarrhea | 2 (2.3) | 1 (1.1) | 3 (3.3) | 2 (2.2) | 5 (2.9) |
| Dyspepsia | 1 (1.1) | 8 (9) | 4 (4.4) | 3 (3.4) | 2 (1.1) |
| Flatulence | 5 (5.7) | 1 (1.1) | 2 (2.2) | 3 (3.4) | 8 (4.6) |
| Gastroenteritis | 2 (2.3) | 3 (3.4) | 4 (4.4) | 3 (3.4) | 0 (0) |
| Nausea | 3 (3.4) | 6 (6.7) | 5 (5.6) | 3 (3.4) | 7 (4) |
| Metabolic And Nutritional | |||||
| Edema Peripheral | 4 (4.6) | 3 (3.4) | 4 (4.4) | 3 (3.4) | 3 (1.7) |
| Weight Increased | 4 (4.6) | 3 (3.4) | 2 (2.2) | 4 (4.5) | 1 (0.6) |
| Musculoskeletal | |||||
| Arthralgia | 12 (13.8) | 5 (5.6) | 10 (11.1) | 11 (12.4) | 2 (1.1) |
| Bone Fracture Spontaneous | 7 (8) | 1 (1.1) | 3 (3.3) | 0 (0) | 0 (0) |
| Joint Disorder | 2 (2.3) | 4 (4.5) | 4 (4.4) | 1 (1.1) | 0 (0) |
| Myalgia | 4 (4.6) | 3 (3.4) | 2 (2.2) | 5 (5.6) | 3 (1.7) |
| Nervous | |||||
| Anxiety | 3 (3.4) | 0 (0) | 9 (10) | 2 (2.2) | 3 (1.7) |
| Depression | 8 (9.2) | 1 (1.1) | 3 (3.3) | 1 (1.1) | 6 (3.4) |
| Dizziness | 0 (0) | 1 (1.1) | 7 (7.8) | 4 (4.5) | 1 (0.6) |
| Hypesthesia | 2 (2.3) | 3 (3.4) | 3 (3.3) | 0 (0) | 0 (0) |
| Insomnia | 7 (8) | 4 (4.5) | 2 (2.2) | 1 (1.1) | 8 (4.6) |
| Respiratory | |||||
| Asthma | 1 (1.1) | 3 (3.4) | 3 (3.3) | 1 (1.1) | 2 (1.1) |
| Bronchitis | 6 (6.9) | 7 (7.9) | 4 (4.4) | 4 (4.5) | 6 (3.4) |
| Cough Increased | 2 (2.3) | 1 (1.1) | 4 (4.4) | 1 (1.1) | 6 (3.4) |
| Infection Respiratory | 23 (26.4) | 22 (24.7) | 22 (24.4) | 19 (21.3) | 28 (16.1) |
| Pharyngitis | 1 (1.1) | 4 (4.5) | 2 (2.2) | 2 (2.2) | 4 (2.3) |
| Pneumonia | 4 (4.6) | 4 (4.5) | 4 (4.4) | 1 (1.1) | 1 (0.6) |
| Sinusitis | 16 (18.4) | 9 (10.1) | 11 (12.2) | 6 (6.7) | 13 (7.5) |
| Skin | |||||
| Application Site Reaction | 51 (58.6) | 47 (52.8) | 51 (56.7) | 49 (55.1) | 10 (5.7) |
| Hirsutism | 0 (0) | 2 (2.2) | 2 (2.2) | 4 (4.5) | 1 (0.6) |
| Pruritus | 4 (4.6) | 2 (2.2) | 1 (1.1) | 6 (6.7) | 9 (5.2) |
| Rash | 5 (5.7) | 6 (6.7) | 8 (8.9) | 4 (4.5) | 5 (2.9) |
| Special Senses | |||||
| Conjunctivitis | 2 (2.3) | 2 (2.2) | 3 (3.3) | 2 (2.2) | 0 (0) |
| Otitis Media | 2 (2.3) | 3 (3.4) | 2 (2.2) | 1 (1.1) | 0 (0) |
| Urogenital | |||||
| Breast Enlargement | 3 (3.4) | 1 (1.1) | 2 (2.2) | 6 (6.7) | 4 (2.3) |
| Infection Urinary Tract | 2 (2.3) | 5 (5.6) | 4 (4.4) | 2 (2.2) | 3 (1.7) |
| Leukorrhea | 1 (1.1) | 3 (3.4) | 2 (2.2) | 4 (4.5) | 3 (1.7) |
| Neoplasm Breast | 6 (6.9) | 3 (3.4) | 5 (5.6) | 1 (1.1) | 3 (1.7) |
| Pain Breast | 7 (8) | 13 (14.6) | 16 (17.8) | 31 (34.8) | 12 (6.9) |
| Vaginitis | 6 (6.9) | 0 (0) | 3 (3.3) | 0 (0) | 14 (8) |
| Vaginal Bleedingc | 4 (12.9) | NA | 6 (8.7) | NA | 29 (33.3) |
| a - Adverse events for the three lower Alora (estradiol transdermal system) doses
and placebo were obtained from the two-year prevention of osteoporosis study
b - Adverse events for the highest Alora (estradiol transdermal system) doses were obtained from two 12-week studies of the treatment of menopausal symptoms c - Data reported for women with partially or fully intact uteri in the menopausal symptom study only (N=31 for Placebo; N=69 for Alora (estradiol transdermal system) 0.05 mg/day and N=87 for Alora (estradiol transdermal system) 0.1 mg/day) NA - data not available |
|||||
The following additional adverse reactions have been reported with estrogens and/or progestin therapy:
- Genitourinary system. Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.
- Breasts. Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
- Cardiovascular. Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
- Gastrointestinal. Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gall bladder disease; pancreatitis; enlargement of hepatic hemangiomas.
- Skin. Chloasma or melasma, which may persist when drug is discontinued; erythema multiform; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus; rash.
- Eyes.Retinal vascular thrombosis; intolerance to contact lenses.
- Central nervous system.Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia.
- Miscellaneous.Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; anaphylactoid/anaphylactic reactions including urticaria and angioedema; hypocalcemia; exacerbation of asthma; increased triglycerides.
Read the entire FDA prescribing information for Alora (Estradiol Transdermal System) »
Additional Alora Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Women's Health
Find out what women really need.
Updated & New
