Fallback Solo Side Effects
Generic name: levonorgestrel
Medically reviewed by Drugs.com. Last updated on Mar 17, 2024.
Note: This document contains side effect information about levonorgestrel. Some dosage forms listed on this page may not apply to the brand name Fallback Solo.
Applies to levonorgestrel: intrauterine insert extended release. Other dosage forms:
Serious side effects of Fallback Solo
Along with its needed effects, levonorgestrel (the active ingredient contained in Fallback Solo) 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 or nurse immediately if any of the following side effects occur while taking levonorgestrel:
More common
- Absent, missed, or irregular menstrual periods
- longer or heavier menstrual periods
- mild bloating
- stomach or pelvic pain or spasm
- stopping of menstrual bleeding
- unusually heavy or unexpected menstrual bleeding
- uterine bleeding between menstrual periods
- vaginal bleeding or spotting
Less common
- Blurred vision
- cramps
- dizziness
- headache
- heavy bleeding
- itching of the vagina or genital area
- nervousness
- pain
- pain during sexual intercourse
- pale skin
- pounding in the ears
- slow or fast heartbeat
- swelling
- thick, white vaginal discharge with mild or no odor
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- white or brownish vaginal discharge
Rare
- Chills
- confusion
- dizziness, lightheadedness, fainting
- fast heartbeat
- fast, weak pulse
- fever
- pale, cold, clammy skin
- rapid, shallow breathing
- sudden increase in stomach or shoulder pain
- sweating
- unusual or large amount of vaginal bleeding
Incidence not known
- Clear or bloody discharge from the nipple
- dimpling of the breast skin
- dull or aching stomach pain
- foul-smelling vaginal discharge
- increased blood pressure
- increased urge to urinate
- inverted nipple
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lump in the breast or under the arm
- pain during urination
- persistent crusting or scaling of the nipple
- redness or swelling of the breast
- severe stomach pain or cramping
- sharp pain on insertion
- shivering fever
- sores on the skin of the breast that does not heal
Other side effects of Fallback Solo
Some side effects of levonorgestrel 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:
More common
- Blemishes on the skin
- breast pain or discomfort
- dandruff
- depression
- nausea or vomiting
- oily skin
- pimples
Less common
- Back pain
- breast tenderness
- decreased interest in sexual intercourse
- full or bloated feeling
- hair loss
- hives or welts, itching, or rash
- increased hair growth, especially on the face
- increased weight
- loss in sexual ability, desire, drive, or performance
- pressure in the stomach
- redness of the skin
- skin rash, encrusted, scaly, and oozing
- swelling of the stomach area
- thinning of the hair
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]
Frequently asked questions
- Can Plan B make your period late or cause bleeding?
- Can you drink alcohol after taking Plan B?
- How effective is Plan B and how late can you take it?
- What's the weight limit for Plan B?
- How many times can you take Plan B?
- Mirena, Kyleena, Skyla & Liletta - What's the difference?
More about Fallback Solo (levonorgestrel)
- Check interactions
- Compare alternatives
- Reviews (1)
- Drug images
- Latest FDA alerts (1)
- Dosage information
- During pregnancy
- Drug class: contraceptives
- En español
Patient resources
Other brands
Mirena, Plan B One-Step, Kyleena, Liletta, ... +17 more
Professional resources
Other brands
Mirena, Plan B One-Step, Kyleena, Liletta, ... +2 more
Related treatment guides
References
1. Product Information. Mirena (levonorgestrel). Berlex Laboratories. 2003.
2. Product Information. Plan B (levonorgestrel). Women's Capital Corporation. 2003.
3. Cerner Multum, Inc. UK Summary of Product Characteristics.
4. Cerner Multum, Inc. Australian Product Information.
5. Product Information. Skyla (levonorgestrel). Bayer Pharmaceutical Inc. 2013.
6. Product Information. Liletta (levonorgestrel). Actavis Pharma, Inc. 2016.
7. Product Information. Kyleena (levonorgestrel). Bayer Pharmaceutical Inc. 2018.
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.