EstroGel
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"March 14, 2013 -- Hormone replacement therapy is the most effective treatment for symptoms like hot flashes, and the benefits are likely to outweigh the risks, major medical societies say.
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EstroGel
EstroGel Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
EstroGel (estradiol) Gel is an estrogen hormone used to treat vasomotor, vulvar and vaginal atrophy symptoms due to menopause. EstroGel should not be used to prevent cardiovascular disease or dementia. Common side effects of EstroGel include nausea, swollen breasts, acne, vaginal pain, dryness, decreased sex drive, weight gain, headaches, dizziness, depression, and vaginal discharge.
The recommended dosage of EstroGel is 1.25 g. St. John's wort, blood thinners, ritonavir, carbamazepine, erythromycin, Ketozole, and itraconazole may interact with EstroGel. Tell your doctor all medications you take. Children should avoid coming into contact with EstroGel. Do not use EstroGel if you are pregnant or breastfeeding.
Our EstroGel (estradiol) Gel 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.
EstroGel 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.
Stop using estradiol topical and 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, headache, confusion, or problems with vision, speech, or balance;
- pain, swelling, warmth, or redness in one or both legs;
- 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;
- vaginal pain, dryness, or discomfort, decreased sex drive, or difficulty having an orgasm;
- swelling, weight gain;
- migraine headaches, dizziness, depression; or
- break-through bleeding, vaginal itching or discharge.
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 EstroGel (Estradiol Gel) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
EstroGel Overview - Patient Information: Side Effects
Nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.
This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.
A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for EstroGel (Estradiol Gel)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
EstroGel 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 event 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.
EstroGel (estradiol gel) 1.25 g was studied in 2 well-controlled 12-week clinical trials. Incidence of adverse events ≥ 5 percent for 1.25 g EstroGel (estradiol gel) and placebo is given below in Table 4.
TABLE 4: Incidence of Treatment-emergent Signs and Symptoms
≥ 5 Percent By COSTART Body System and by Descending Frequency of Occurrence
in the EstroGel (estradiol gel) Treatment Group for the Intent-to-Treat Safety Population in
2 Well-controlled Clinical Studies (Expressed as Percent of Treatment Group)
| Body System/Treatment-emergent Signs and Symptoms |
EstroGel 1.25 g day (n=168) |
Placebo (n=73) |
| BODY AS A WHOLE | ||
| Headache | 20.2 | 17.8 |
| Infection* | 17.3 | 6.8 |
| Pain† | 7.1 | 11.0 |
| Abdominal pain | 7.7 | 1.4 |
| Back pain | 4.8 | 4.1 |
| Flu syndrome | 5.4 | 1.4 |
| Asthenia | 4.8 | 4.1 |
| CARDIOVASCULAR SYSTEM | ||
| Palpitations | 0.6 | 1.4 |
| DIGESTIVE SYSTEM | ||
| Nausea | 6.0 | 4.1 |
| Flatulence | 6.5 | 5.5 |
| Diarrhea | 4.2 | 0.0 |
| METABOLIC and NUTRITIONAL SYSTEMS | ||
| Weight gain | 2.4 | 0.0 |
| NERVOUS SYSTEM | ||
| Nervousness | 2.4 | 1.4 |
| Depression | 3.0 | 2.7 |
| Anxiety | 1.8 | 0.0 |
| RESPIRATORY SYSTEM | ||
| Sinusitis | 3.6 | 1.4 |
| Rhinitis | 2.4 | 6.8 |
| SKIN AND APPENDAGES | ||
| Rash‡ | 7.1 | 5.5 |
| Pruritus‡ | 4.8 | 2.7 |
| Application-site reaction | 0.6 | 0.0 |
| UROGENITAL | ||
| Breast pain | 12.5 | 9.6 |
| Metrorrhagia | 3.0 | 0.0 |
| Endometrial disorder§ | 1.8 | 1.4 |
| Vaginitis | 8.9 | 4.1 |
| Pap smear suspicious|| | 5.4 | 2.7 |
| Vaginal hemorrhage | 1.2 | 0.0 |
| *Infection: upper respiratory infection, common cold, eye
infection. †Pain: generalized and extremity aches/pains, cramps. ‡Rash and pruritus: more than half of the EstroGel (estradiol gel) -treated patients who had pruritus reported itching at a body site other than the arms or reported generalized itching or itching skin. Similarly, most of the EstroGel (estradiol gel) -treated patients with rash had rash on 1 or more areas of the body in addition to the arms. §Endometrial disorder: proliferative endometrium, benign endometrial disorders. || Pap smear suspicious: atypical squamous cells of undetermined significance, inflammatory changes, epithelial cell abnormality. |
||
The following additional adverse events have been reported with estrogen and/or progestin therapy.
- Genitourinary system: abnormal uterine bleeding/spotting; dysmenorrhea/pelvic pain; 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 gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas
- Skin: chloasma or melasma, that may persist when drug is discontinued; erythema multiforme; 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; exacerbation of chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia
- Miscellaneous: increase or decrease in weight; glucose intolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia (preexisting condition); exacerbation of asthma; increased triglycerides
Read the entire FDA prescribing information for EstroGel (Estradiol Gel) »
Additional EstroGel Information
EstroGel - User Reviews
EstroGel User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication EstroGel sorted by most helpful.
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.
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