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Alora

Last reviewed on RxList: 1/30/2017
Alora Side Effects Center

Last reviewed on RxList 01/25/2017

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. 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).

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.

Alora Consumer Information

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, 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);
  • unusual vaginal bleeding;
  • 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).

Less serious side effects may include:

  • upset stomach, bloating, constipation;
  • acne or skin color changes, increased facial hair, thinning scalp hair;
  • mild headache, back pain, joint pain;
  • cold symptoms such as stuffy nose, sneezing, sinus pain, sore throat;
  • breast swelling and tenderness, nipple discharge; 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)

Alora Professional Information

SIDE EFFECTS

See BOXED WARNINGS and 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.

The following additional adverse reactions have been reported with estrogens and/or progestin therapy:

  1. Genitourinary system. Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea; 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.
  2. Breasts. Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
  3. Cardiovascular. Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
  4. Gastrointestinal. Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gall bladder disease; pancreatitis; enlargement of hepatic hemangiomas.
  5. Skin. Chloasma or melasma, which may persist when drug is discontinued; erythema multiform; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus; rash.
  6. Eyes. Retinal vascular thrombosis; intolerance to contact lenses.
  7. Central nervous system. Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia.
  8. 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.

Table 5: Incidence of Adverse Events > 2% for Alora and Placebo Systems (data are expressed as N and (%) of treatment group).

Body System
Preferred Term
Placeboa
(N = 87)
Aloraa 0.025 mg/day
(N = 89)
Aloraa 0.05 mg/day
(N = 90)
Aloraa 0.075 mg/day
(N = 89)
Alorab 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 doses and placebo were obtained from the 2-year prevention of osteoporosis study
b Adverse events for the highest Alora 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 0.05 mg/day and N = 87 for Alora 0.1 mg/day)
NA - data not available

Read the entire FDA prescribing information for Alora (Estradiol Transdermal System)

Related Resources for Alora

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© 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.

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