Activella Side Effects
Generic Name: estradiol / norethindrone
Note: This page contains information about the side effects of estradiol / norethindrone. Some of the dosage forms included on this document may not apply to the brand name Activella.
Not all side effects for Activella may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to estradiol / norethindrone: oral tablet
Other dosage forms:
In addition to its needed effects, some unwanted effects may be caused by estradiol / norethindrone. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking estradiol / norethindrone:More common
- Body aches or pain
- chills or fever
- cold or flu-like symptoms
- difficulty breathing
- itching of the vagina or genital area
- nonmenstrual vaginal bleeding
- pain during sexual intercourse
- thick, white vaginal discharge with no odor or with a mild odor
- unusual tiredness or weakness
- Abdominal or stomach pain
- blistering, peeling, or loosening of the skin
- change in vaginal discharge
- chest pain, discomfort, or tightness in chest
- clay-colored stools
- clear or bloody discharge from the nipple
- dark urine
- difficulty speaking
- difficulty swallowing
- dizziness or lightheadedness
- double vision
- 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
- sudden shortness of breath or troubled breathing
- trouble recognizing objects
- trouble thinking and planning
- trouble walking
Some of the side effects that can occur with estradiol / norethindrone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Back pain
- breast pain
- mental depression
- quick to react or overreact emotionally
- rapidly changing moods
- trouble sleeping
- weight gain
- 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
Gastrointestinal side effects have included nausea (8% to 11%), abdominal pain (6% to 7%), diarrhea (4% to 5%), flatulence (4% to 5%), and dyspepsia (1% to 5%).
General side effects have included headache (18% to 20%), asthenia (8% to 12%), back pain (9% to 11%), flu syndrome (5% to 9%), pain (4% to 6%), and accidental injury (4% to 5%). Postmarketing side effects include increased weight.
Genitourinary side effects have included breast pain (25% to 31%), dysmenorrhea (20% to 21%), vaginitis (6% to 13%), menstrual disorder (6% to 12%), suspicious Papanicolaou smear (4% to 8%), and leukorrhea (5%). Endometrial thickening (10% to 4%) and vaginal hemorrhage (26% to 12%) have also been reported. Postmarketing side effects include endometrial hyperplasia, endocervical polyp, uterine leiomyomata, fallopian tube cyst, uterine spasms, and breast cancer.
Local side effects have included reactions at the application site (2% to 6%).
Psychiatric side effects have included nervousness (3% to 6%) and depression (3% to 6%).
Respiratory side effects have included rhinitis (7% to 13%), respiratory disorder (7% to 12%), pharyngitis (4% to 10%), and sinusitis (4% to 9%).
Cardiovascular side effects include postmarketing reports of hypertension and varicose veins.
Dermatologic side effects include postmarketing reports of skin discoloration.
Hepatic side effects include postmarketing reports of jaundice cholestatic, cholelithiasis, gall bladder disorder, and increased transaminases.
Hypersensitivity side effects include postmarketing reports of angioedema and hypersensitivity.
Nervous system side effects include postmarketing reports of affect lability, libido disorder, migraine, vertigo, and paraesthesia.
More about Activella (estradiol / norethindrone)
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