Aftera

Name: Aftera

What are some other side effects of Aftera?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach or throwing up.
  • Breast soreness.
  • Dizziness.
  • Period (menstrual) changes.
  • Belly pain.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Aftera or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aftera. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

For Healthcare Professionals

Applies to levonorgestrel: intrauterine device, oral tablet, subcutaneous implant

General

The most commonly reported adverse effects are alterations of menstrual bleeding patterns, nausea, abdominal/pelvic pain, headache/migraine, dizziness, fatigue, amenorrhea, ovarian cysts, genital discharge, acne/seborrhea, breast tenderness, and vulvovaginitis.[Ref]

Genitourinary

Very common (10% or more): Irregular menstrual bleeding (67%), infrequent menstrual bleeding (up to 57%), ovarian cyst (31.2%), menstrual changes (up to 31.9%), decreased uterine bleeding (23.4%), prolonged menstrual bleeding (22%), vulvovaginitis (20.2%), amenorrhea (18.4%), genital discharge (up to 14.9%), heavier menstrual bleeding (13.8%),vaginal infections (13.6%), vulvovaginal infections (13.3%), lighter menstrual bleeding (12.5%), increased scheduled uterine bleeding (11.9%), breast tenderness (10.7%)
Common (1% to 10%): Dysmenorrhea, breast pain/discomfort, upper genital tract infection, genital tract bleeding, pelvic inflammatory disease, endometritis, dyspareunia, pelvic discomfort/pain, delay of menses more than 7 days, vaginal discharge, bleeding not related to menses
Uncommon (0.1% to 1%): Uterine spasm, cervicitis/Papanicolaou smear normal class II, change in vaginal secretion
Rare (less than 0.1%): Uterine perforation
Frequency not reported: Breast enlargement, vaginal candidiasis, changes in cervical erosion, changes in cervical secretion, ectopic pregnancy
Postmarketing reports: Oligomenorrhea, irregular menstruation[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 23.1%), abdominal/pelvic pain (up to 22.6%)
Common (1% to 10%): Diarrhea, vomiting
Uncommon (0.1% to 1%): Abdominal distension
Frequency not reported: Bloating, abdominal cramps[Ref]

Other

Very common (10% or more): Fatigue (16.9%)
Common (1% to 10%): Partial/complete IUS expulsion, weight increased
Uncommon (0.1% to 1%): Edema, change in body weight
Very rare (less than 0.01%): Face edema
Frequency not reported: Decreased weight, sepsis, group A streptococcal sepsis
Postmarketing reports: IUS breakage, procedural bleeding[Ref]

Nervous system

Very common (10% or more): Headache (up to 16.8%), dizziness (11.2%)
Common (1% to 10%): Migraine
Postmarketing reports: Stroke, syncope, IUS insertion related vasovagal reaction or seizure[Ref]

Psychiatric

Common (1% to 10%): Depression/depressed mood, mood changes, mood swings, decreased libido, nervousness
Frequency not reported: Changes in libido[Ref]

Dermatologic

Very common (10% or more): Acne/seborrhea (15%)
Common (1% to 10%): Alopecia, hirsutism
Uncommon (0.1% to 1%): Pruritus, eczema, pigmentation changes/hyperpigmentation
Rare (less than 0.1%): Rash, urticaria
Frequency not reported: Chloasma, melasma
Postmarketing reports: Angioedema[Ref]

Cardiovascular

Postmarketing reports: Increased blood pressure, arterial/venous thrombotic events, pulmonary emboli, deep vein thrombosis, stroke[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Oncologic

Frequency not reported: Benign/malignant liver tumors
Postmarketing reports: Breast cancer[Ref]

Ocular

Frequency not reported: Contact lens intolerance[Ref]

Metabolic

Frequency not reported: Diabetes mellitus[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction
Postmarketing reports: Hypersensitivity reactions[Ref]

Some side effects of Aftera may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Levonorgestrel Breastfeeding Warnings

Contraceptive use of this drug does not adversely affect the content or volume of breast milk nor the growth and development of the infant. Reports have demonstrated that approximately 0.1% of the maternal dose is transferred to the infant during breastfeeding, resulting in detectable steroid levels in infant plasma. However, there are no reports of adverse effects in infants breastfed by mothers taking progestin-only contraceptives. Isolated postmarketing cases of decreased milk production have been reported.

Use is considered acceptable. Excreted into human milk: Yes Comments: -This drug has been used without apparent harmful effects in the nursing infant. -When taken as a postcoital contraceptive, breastfeeding can resume 3 to 4 hours following each dose. -Uterine bleeding and perforation may be increased in lactating women using an intrauterine system.

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