Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years. Keep this product out of reach of children. If overdose does occur, get medical help right away or call a poison control center.
Junel Fe 1/20 Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 3, 2022.
Note: This document contains side effect information about ethinyl estradiol / norethindrone. Some dosage forms listed on this page may not apply to the brand name Junel Fe 1/20.
Applies to ethinyl estradiol / norethindrone: oral capsule liquid filled, oral tablet, oral tablet chewable. Other dosage forms:
Warning
Oral route (Tablet)
Junel®, Loestrin®, Microgestin®, Tri-Legest®: Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.Femhrt®: Estrogen alone or with a progestin should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke, DVT, pulmonary embolism, myocardial infarction, and invasive breast cancer have been reported with estrogen plus progestin therapy. Increased risks of stroke and DVT have been reported with estrogen-alone therapy, along with increased risk for endometrial cancer in a woman with a uterus who uses unopposed estrogens. An increased risk of probable dementia in postmenopausal women aged 65 and older has been reported with estrogen alone and with estrogen plus progestin therapy. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration possible.
Serious side effects of Junel Fe 1/20
Along with its needed effects, ethinyl estradiol/norethindrone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol/norethindrone:
Incidence not known
- Absent, missed, or irregular menstrual periods
- anxiety
- change in vision
- changes in skin color
- chest pain or discomfort
- chills
- clay-colored stools
- constipation
- cough
- dark urine
- diarrhea
- dizziness or lightheadedness
- fainting
- fast heartbeat
- fever
- headache
- hives or welts
- itching skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
- nausea
- pain or discomfort in the arms, jaw, back, or neck
- pain, tenderness, or swelling of the foot or leg
- pains in the chest, groin, or legs, especially in the calves of the legs
- pounding in the ears
- rash
- redness of the skin
- severe headaches of sudden onset
- slow or fast heartbeat
- stomach pain
- sudden loss of coordination or slurred speech
- sweating
- troubled breathing
- unusual tiredness or weakness
- vomiting
- vomiting of blood
Other side effects of Junel Fe 1/20
Some side effects of ethinyl estradiol/norethindrone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Bloating
- blotchy spots on the exposed skin
- breast enlargement or tenderness
- discouragement
- feeling sad or empty
- irritability
- itching of the vagina or outside genitals
- loss of interest or pleasure
- pain during sexual intercourse
- stomach cramps
- thick, white curd-like vaginal discharge without odor or with mild odor
- tiredness
- trouble concentrating
- trouble sleeping
- trouble wearing contact lenses
For Healthcare Professionals
Applies to ethinyl estradiol / norethindrone: oral capsule, oral tablet, oral tablet chewable.
General
The most frequently reported side effects were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, abdominal pain, mood changes, bacterial vaginitis, acne, irregular uterine bleeding, and weight gain. [Ref]
Genitourinary
Common (1% to 10%): Vaginal candidiasis, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal/irregular bleeding, metrorrhagia, irregular menstruation, menorrhagia, vaginal hemorrhage, breast pain, dysmenorrhea, vaginal hemorrhage, dysfunctional uterine bleeding
Frequency not reported: Ovarian vein thrombosis, vaginitis, amenorrhea, breakthrough bleeding, breast enlargement, breast secretion, cervical erosion changed, cervical secretion, menstrual flow changed, diminution in lactation, spotting, temporary infertility after discontinuation of treatment, premenstrual syndrome, uterine fibroid disease exacerbated
Postmarketing reports: Vaginal infection, pollakiuria, dysuria, ovarian cyst, pelvic pain, ovarian cyst rupture, pelvic fluid collection, nipple pain, nipple discharge, galactorrhea, fibrocystic breast change, breast disorder, breast mass, uterine leiomyomata size increased, cervical ectropion changed, endometrial hyperplasia, ovarian cyst, uterine enlargement [Ref]
Cardiovascular
Uncommon (0.1% to 1%): Blood pressure increased
Frequency not reported: Deep vein thrombosis, myocardial infarction, hypertension, arterial thromboembolism, thrombophlebitis
Postmarketing reports: Coronary artery thrombosis, palpitation, tachycardia, angina pectoris, hot flush, heart rate irregular [Ref]
Gastrointestinal
Common (1% to 10%): Nausea/vomiting, abdominal pain
Frequency not reported: Abdominal cramps, bloating, colitis, dyspepsia, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, mesenteric thrombosis
Postmarketing reports: Constipation, pancreatitis [Ref]
Nervous system
Common (1% to 10%): Headache
Frequency not reported: Migraine, dizziness, cerebral hemorrhage, cerebral thrombosis
Postmarketing reports: Loss of consciousness, hyperesthesia, paresthesia, hypoesthesia, somnolence, sensory disturbance, transient ischemic attack, ischemic stroke, chorea, epilepsy exacerbated, dementia, hemiparesis [Ref]
Oncologic
Frequency not reported: Hepatic adenoma, hepatic carcinoma, benign liver tumor
Endocrine
Postmarketing reports: Hypothyroidism, hyperthyroidism [Ref]
Psychiatric
Common (1% to 10%): Mood swing, depression, mood changed, anxiety
Frequency not reported: Nervousness
Postmarketing reports: Insomnia, suicidal ideation, panic attack, libido changed, homicidal ideation, dissociation, bipolar disorder, mood disturbed, irritability [Ref]
Dermatologic
Common (1% to 10%): Acne
Frequency not reported: Hirsutism, loss of scalp hair, melasma, chloasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, photosensitivity, pruritus
Postmarketing reports: Alopecia, generalized rash, allergic rash, skin discoloration, urticaria, angioedema, night sweats, angioedema, hirsutism, skin burning sensation, generalized erythema [Ref]
Hepatic
Frequency not reported: Liver disease, gallbladder disease, cholestatic jaundice, Budd-Chiari syndrome
Hematologic
Postmarketing reports: Anemia [Ref]
Immunologic
Postmarketing reports: Hypersensitivity reaction, anaphylactic/anaphylactoid reaction [Ref]
Ocular
Frequency not reported: Corneal curvature change/steepening, contact lens intolerance, cataracts, retinal thrombosis
Postmarketing reports: Vision blurred, vision impaired, corneal thinning, fungal infection, transient blindness [Ref]
Respiratory
Frequency not reported: Pulmonary embolism
Postmarketing reports: Asthma exacerbated, dyspnea [Ref]
Musculoskeletal
Frequency not reported: Leg cramp, backache
Postmarketing reports: Myalgia, arthralgia, back pain [Ref]
Metabolic
Common (1% to 10%): Weight fluctuation
Frequency not reported: Tolerance to carbohydrates reduced
Postmarketing reports: Appetite increased, appetite decreased, diabetes mellitus, hypoglycemia, hypocalcemia, triglycerides increased, blood glucose abnormal [Ref]
Other
Common (1% to 10%): Cervical smear abnormal, weight gain, edema
Frequency not reported: Fatigue, porphyria, Vitamin B6 deficient
Postmarketing reports: Weight decreased, peripheral edema, malaise, chest pain [Ref]
Renal
Frequency not reported: Renal function impaired
Postmarketing reports: Cystitis-like syndrome [Ref]
More about Junel Fe 1 / 20 (ethinyl estradiol / norethindrone)
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- Pricing & coupons
- Reviews (895)
- Drug images
- Dosage information
- During pregnancy
- Drug class: contraceptives
Patient resources
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Professional resources
Related treatment guides
References
1. “Product Information. femhrt (ethinyl estradiol-norethindrone).” Parke-Davis
2. “Product Information. Estrostep Fe (ethinyl estradiol-norethindrone).” Parke-Davis (2002):
3. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
4. Cerner Multum, Inc. “Australian Product Information.” O 0
5. “Product Information. Loestrin 24 Fe (ethinyl estradiol-norethindrone).” Warner Chilcott Laboratories (2017):
6. “Product Information. Briellyn (ethinyl estradiol-norethindrone).” Glenmark Pharmaceuticals Inc (2017):
7. “Product Information. Femcon FE (ethinyl estradiol-norethindrone).” Actavis (formerly Abrika Pharmaceuticals LLP) (2017):
8. “Product Information. Lo Loestrin Fe (ethinyl estradiol-norethindrone).” Warner Chilcott Laboratories (2017):
9. “Product Information. Lo Minastrin Fe (ethinyl estradiol-norethindrone).” Warner Chilcott Laboratories (2017):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
Junel FE – Uses, Side Effects, and More
Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years. Keep this product out of reach of children. If overdose does occur, get medical help right away or call a poison control center.
Warnings:
Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years. Keep this product out of reach of children. If overdose does occur, get medical help right away or call a poison control center.
Uses
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: norethindrone (a progestin) and ethinyl estradiol (an estrogen). There is a small amount of iron (ferrous fumarate) in each of the 7 inactive tablets taken during the fourth week. The inactive pills do not contain any hormones. These tablets are meant to keep you in the habit of taking 1 tablet each day and do not have enough iron to treat iron deficiency.Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne.Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
How to use Junel FE
Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on when to take your pills and what to do if you miss a dose. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily. Pick a time of day that is easy for you to remember, and take your pill at the same time each day.
If you are taking the chewable tablet, you may either swallow it whole or chew it thoroughly and swallow.
It is very important to continue taking this medication exactly as prescribed by your doctor. Follow the package instructions to find the first tablet, start with the first tablet in the pack, and take them in the correct order. Do not skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual.
Vomiting or diarrhea can prevent your birth control pills from working well. If you have vomiting or diarrhea, you may need to use a back-up birth control method (such as condoms, spermicide). Follow the directions in the Patient Information Leaflet and check with your doctor or pharmacist for more details.
Taking this medication after your evening meal or at bedtime may help if you have any stomach upset or nausea with the medication. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart. Ask your doctor or pharmacist if you have any questions.
Your pill pack contains 21 pills with active medication. It also contains 7 reminder pills with iron. Take one active pill (with hormones) once daily for 21 days in a row. Take one inactive pill (with iron) once daily for 7 days in a row after you have taken the last active pill unless otherwise directed by your doctor. You should have your period during the fourth week of the pack. After you have taken the last iron tablet in the pack, start a new pack the next day whether or not you have your period. If you do not get your period, consult your doctor.
If you are taking certain medications (such as levodopa, levothyroxine, penicillamine, tetracyclines, quinolones such as ciprofloxacin) that can interact with iron, ask your doctor whether you should throw away the reminder pills (iron tablets) each day rather than taking them. Iron can decrease the effect of these medications.
If this is the first time you are using this medication and you are not switching from another form of hormonal birth control (such as patch, other birth control pills), take the first tablet in the pack on the first Sunday following the beginning of your menstrual period or on the first day of your period. If your period begins on a Sunday, begin taking this medication on that day. For the first cycle of use only, use an additional form of non-hormonal birth control (such as condoms, spermicide) for the first 7 days to prevent pregnancy until the medication has enough time to work. If you start on the first day of your period, you do not need to use back-up birth control the first week.
Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (such as patch, other birth control pills) to this product. If any information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.
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