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Fallback Solo Side Effects

Generic Name: levonorgestrel

Note: This page contains information about the side effects of levonorgestrel. Some of the dosage forms included on this document may not apply to the brand name Fallback Solo.

For the Consumer

Applies to levonorgestrel: oral tablet

In addition to its needed effects, some unwanted effects may be caused by levonorgestrel (the active ingredient contained in Fallback Solo). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking levonorgestrel:

More common:
  • Heavy or light menstrual bleeding
Incidence not known:
  • Absent missed or irregular menstrual periods
  • cramps
  • irregular menstruation
  • pain
  • pain in the pelvis
  • stopping of menstrual bleeding

Minor Side Effects

Some of the side effects that can occur with levonorgestrel 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:
  • Abdominal or stomach pain
  • dizziness
  • headache
  • nausea
  • tenderness of the breasts
  • unusual tiredness or weakness
  • vomiting
Less common:
  • Diarrhea

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]

References

1. "Product Information. Liletta (levonorgestrel)." Actavis Pharma, Inc., Parsippany, NJ.

2. "Product Information. Plan B (levonorgestrel)." Women's Capital Corporation, Bellevue, WA.

3. "Product Information. Mirena (levonorgestrel)." Berlex Laboratories, Richmond, CA.

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. "Product Information. Skyla (levonorgestrel)." Bayer Pharmaceutical Inc, West Haven, CT.

6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Not all side effects for Fallback Solo may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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