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Levonorgestrel Side Effects

Common Levonorgestrel Side Effects


The most commonly reported Levonorgestrel side effects (click to view or check a box to report):

Nausea (34)
Vomiting (20)
Pulmonary Embolism (19)
Abdominal Pain (19)
Dizziness (18)
Headache (18)
Device Dislocation (16)
Pregnancy On Oral Contraceptive (14)
Abortion Spontaneous (13)
Abdominal Pain Upper (13)
Metrorrhagia (13)
Vaginal Haemorrhage (13)
Amenorrhoea (13)
Pregnancy With Contraceptive Device (12)
Ectopic Pregnancy (11)
Maternal Exposure During Pregnancy (11)
Breast Cancer Female (11)
Pregnancy After Post Coital Contraception (11)
Unintended Pregnancy (11)
Pain (11)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Levonorgestrel Side Effects Reported to FDA

The following Levonorgestrel reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Levonorgestrel on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Pregnancy With Contraceptive Device, Maternal Exposure During Pregnancy
This is a report of a 26-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: contraception, who was treated with Levonorgestrel (dosage: NA, start time: NS), combined with:
  • Medroxyprogesterone /00115202/
and developed a serious reaction and side effect(s). The consumer presented with:
  • Pregnancy With Contraceptive Device
  • Maternal Exposure During Pregnancy
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levonorgestrel treatment in female patients, resulting in pregnancy with contraceptive device side effect.

Adnexa Uteri Mass, Ovarian Germ Cell Teratoma Benign
This report suggests a potential Levonorgestrel Adnexa Uteri Mass, Ovarian Germ Cell Teratoma Benign side effect(s) that can have serious consequences. A 25-year-old female patient (weight: NA) from IE was diagnosed with the following symptoms/conditions: menorrhagia and used Levonorgestrel (dosage: 20 Mcg/24hr, Cont) starting NS. Soon after starting Levonorgestrel the patient began experiencing various side effects, including:
  • Adnexa Uteri Mass
  • Ovarian Germ Cell Teratoma Benign
Drugs used concurrently: NA. Although Levonorgestrel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as adnexa uteri mass, may still occur.

Ovarian Cyst Ruptured, Abdominal Pain, Asthenia, Dizziness, Vaginal Discharge, Abdominal Distension
This Ovarian Cyst Ruptured, Abdominal Pain, Asthenia, Dizziness, Vaginal Discharge, Abdominal Distension problem was reported by a consumer or non-health professional from US. A 21-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On Oct 06, 2012 this consumer started treatment with Levonorgestrel (dosage: 20 Mcg/24hr, Cont). The following drugs were being taken at the same time: NA. When commencing Levonorgestrel, the patient experienced the following unwanted symptoms/side effects:
  • Ovarian Cyst Ruptured
  • Abdominal Pain
  • Asthenia
  • Dizziness
  • Vaginal Discharge
  • Abdominal Distension
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as ovarian cyst ruptured, may become evident only after a product is in use by the general population.

Pulmonary Embolism, Myocardial Infarction
This is a report of a 44-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: contraception and was treated with Levonorgestrel (dosage: NA) starting Oct 11, 2011. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Pulmonary Embolism
  • Myocardial Infarction
The patient was hospitalized. This opens a possibility that Levonorgestrel treatment could cause the above reactions, including pulmonary embolism, and some female subjects may be more susceptible.


Hypoaesthesia
A 51-year-old female patient (weight: NA) from US with the following symptoms/conditions: contraception,asthma started Levonorgestrel And Ethinyl Estradiol Tablets Usp treatment (dosage: NA) on Aug 11, 2013. Soon after starting Levonorgestrel And Ethinyl Estradiol Tablets Usp treatment, the subject experienced various side effects, including:
  • Hypoaesthesia
Concurrently used drugs:
  • Advair (Allergies)
  • Flovent (Allergies)
This finding indicates that some female patients could be more vulnerable to Levonorgestrel And Ethinyl Estradiol Tablets Usp.

Depression
A 40-year-old female patient from US (weight: NA) experienced symptoms, such as: NA and was treated with Levonorgestrel And Ethinyl Estradiol Tablets Usp(dosage: NA). The treatment was initiated on 201308. After that a consumer reported the following side effect(s):
  • Depression
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Levonorgestrel And Ethinyl Estradiol Tablets Usp efficacy: NA.

Mood Altered, Crying
In this report, Levonorgestrel And Ethinyl Estradiol Tablets Usp was administered for the following condition: menstrual disorder.A 12-year-old female consumer from US (weight: NA) started Levonorgestrel And Ethinyl Estradiol Tablets Usp treatment (dosage: Taking 2 Tablets Daily. (strength Per Tablet 0.15 Mg/0.03 Mg)) on 201305.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Mood Altered
  • Crying
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Levonorgestrel And Ethinyl Estradiol Tablets Usp treatment could be related to the listed above side effect(s).

Uterine Perforation, Abdominal Pain Lower, Device Difficult To Use, Infertility Female, Ovarian Cyst
This is a report of the following Levonorgestrel side effect(s):
  • Uterine Perforation
  • Abdominal Pain Lower
  • Device Difficult To Use
  • Infertility Female
  • Ovarian Cyst
A 31-year-old female patient from CA (weight: NA) presented with the following condition: NA and received a treatment with Levonorgestrel (dosage: 20 Mcg/24hr, Cont) starting: NS.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Levonorgestrel treatment could be associated with the listed above side effect(s).

Uterine Perforation, Peritonitis, Sepsis
This Levonorgestrel report was submitted by a 28-year-old female consumer from US (weight: NA). The patient was diagnosed with: contraception and Levonorgestrel was administered (dosage: Unk, Cont) starting: NS. The consumer developed a set of symptoms:
  • Uterine Perforation
  • Peritonitis
  • Sepsis
Other drugs used simultaneously:
  • Prednisone
  • Hydroxychloroquine
The patient was hospitalized.Those unexpected symptoms could be linked to a Levonorgestrel treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Deep Vein Thrombosis
This is a report of a possible correlation between Levonorgestrel use and the following symptoms/side effect(s):
  • Deep Vein Thrombosis
which could contribute to an assessment of Levonorgestrel risk profile.A 30-year-old female consumer from US (weight: NA) was suffering from NA and was treated with Levonorgestrel (dosage: NA) starting Feb 01, 2013.Other concurrent medications:
  • Isotretinoin (60 Mg A Day Po)


Pregnancy With Contraceptive Device, Vaginal Haemorrhage, Maternal Exposure During Pregnancy
A 30-year-old female patient from AU (weight: NA) presented with the following symptoms: contraception and after a treatment with Levonorgestrel (dosage: Unk) experienced the following side effect(s):
  • Pregnancy With Contraceptive Device
  • Vaginal Haemorrhage
  • Maternal Exposure During Pregnancy
The treatment was started on Nov 17, 2005. Levonorgestrel was used in combination with the following drugs: NA.This report could alert potential Levonorgestrel consumers.

Pregnancy With Contraceptive Device, Maternal Exposure During Pregnancy
In this report, a 41-year-old female patient from AU (weight: NA) was affected by a possible Levonorgestrel side effect.The patient was diagnosed with contraception. After a treatment with Levonorgestrel (dosage: Unk, start date: NS), the patient experienced the following side effect(s):
  • Pregnancy With Contraceptive Device
  • Maternal Exposure During Pregnancy
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Levonorgestrel treatment.

Pregnancy With Contraceptive Device, Maternal Exposure During Pregnancy
This is a report of a 41-year-old female patient from AU (weight: NA), who used Levonorgestrel (dosage: Unk) for a treatment of contraception. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Pregnancy With Contraceptive Device
  • Maternal Exposure During Pregnancy
The following drugs could possibly have interacted with the Levonorgestrel treatment NA.Taken together, these observations suggest that a Levonorgestrel treatment could be related to side effect(s), such as Pregnancy With Contraceptive Device, Maternal Exposure During Pregnancy.

Vulvovaginitis Streptococcal, Vulvovaginal Discomfort, Beta Haemolytic Streptococcal Infection, Tonsillitis, Vulvovaginal Candidiasis, Procedural Pain
This vulvovaginitis streptococcal side effect was reported by a physician from AU. A 23-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception,routine health maintenance,headache,back pain. The patient was prescribed Levonorgestrel (lcs, 12?g/d, 28x30) (dosage: 12 ?g (daily Dose), Cont, Intra-uterine), which was started on Apr 20, 2010. Concurrently used drugs:
  • Inner Health Plus (1 Df (daily Dose), Bid, Oral)
  • Aspirin (600 Mg, Prn)
  • Panadeine Plus (Unk)
When starting to take Levonorgestrel (lcs, 12?g/d, 28x30) the consumer reported the following symptoms:
  • Vulvovaginitis Streptococcal
  • Vulvovaginal Discomfort
  • Beta Haemolytic Streptococcal Infection
  • Tonsillitis
  • Vulvovaginal Candidiasis
  • Procedural Pain
The patient was hospitalized. These side effects may potentially be related to Levonorgestrel (lcs, 12?g/d, 28x30).

Device Dislocation, Pregnancy With Contraceptive Device, Cervicitis Streptococcal, Escherichia Test Positive
This is a Levonorgestrel side effect report of a 30-year-old female patient (weight:NA) from PL, suffering from the following symptoms/conditions: contraception, who was treated with Levonorgestrel (dosage:20 Mcg/24hr, Cont, start time: NS), combined with: NA., and developed a serious reaction and a device dislocation side effect. The patient presented with:
  • Device Dislocation
  • Pregnancy With Contraceptive Device
  • Cervicitis Streptococcal
  • Escherichia Test Positive
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Levonorgestrel treatment in female patients suffering from contraception, resulting in device dislocation.

Device Dislocation, Pregnancy With Contraceptive Device, Abdominal Pain
This report suggests a potential Levonorgestrel device dislocation side effect(s) that can have serious consequences. A 26-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): NA and used Levonorgestrel (dosage: Unk Unk, Cont) starting NS. Soon after starting Levonorgestrel the patient began experiencing various side effects, including:
  • Device Dislocation
  • Pregnancy With Contraceptive Device
  • Abdominal Pain
Drugs used concurrently:NA. Although Levonorgestrel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as device dislocation, may still occur.

Abortion Induced, Exposure During Pregnancy, Headache
This abortion induced problem was reported by a health professional from CZ. A 32-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): post coital contraception.On Dec 19, 2011 a consumer started treatment with Levonorgestrel (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Levonorgestrel, the patient experienced the following unwanted symptoms /side effects:
  • Abortion Induced
  • Exposure During Pregnancy
  • Headache
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as abortion induced, may become evident only after a product is in use by the general population.

Complication Of Device Insertion
This is a Levonorgestrel Iud 52 Mg Bayer side effect report of a 17-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: contraception and was treated with Levonorgestrel Iud 52 Mg Bayer (dosage: 52 Mg X1 Intra-uterine) starting Feb 22, 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Complication Of Device Insertion
This opens a possibility that Levonorgestrel Iud 52 Mg Bayer could cause complication of device insertion and that some female patients may be more susceptible.

Device Difficult To Use, Vaginal Haemorrhage, Complication Of Device Insertion, Procedural Pain
A 41-year-old female patient (weight: NA) from SE with the following symptoms: NA started Levonorgestrel treatment (dosage: Unk) on NS. Soon after starting Levonorgestrel treatment, the consumer experienced several side effects, including:
  • Device Difficult To Use
  • Vaginal Haemorrhage
  • Complication Of Device Insertion
  • Procedural Pain
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Levonorgestrel side effects, such as device difficult to use.

Genital Haemorrhage, Coital Bleeding, Procedural Pain
This genital haemorrhage side effect was reported by a consumer or non-health professional from SE. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Levonorgestrel (dosage: Unk), which was started on NS. Concurrently used drugs: NA..When starting to take Levonorgestrel the consumer reported symptoms, such as:
  • Genital Haemorrhage
  • Coital Bleeding
  • Procedural Pain
These side effects may potentially be related to Levonorgestrel.

Device Dislocation, Device Difficult To Use
This is a report of a 35-year-old female patient (weight: NA) from SE, suffering from the following symptoms/conditions: NA, who was treated with Levonorgestrel (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Device Dislocation
  • Device Difficult To Use
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levonorgestrel treatment in female patients, resulting in device dislocation side effect.

Device Dislocation, Medical Device Pain
This report suggests a potential Levonorgestrel Device Dislocation, Medical Device Pain side effect(s) that can have serious consequences. A 42-year-old female patient (weight: NA) from SE was diagnosed with the following symptoms/conditions: NA and used Levonorgestrel (dosage: Unk) starting NS. Soon after starting Levonorgestrel the patient began experiencing various side effects, including:
  • Device Dislocation
  • Medical Device Pain
Drugs used concurrently: NA. Although Levonorgestrel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as device dislocation, may still occur.

Dehydration, Nausea, Abdominal Tenderness, Chills, Headache, Dysuria, Pollakiuria, Constipation, Blood Glucose Decreased
This Dehydration, Nausea, Abdominal Tenderness, Chills, Headache, Dysuria, Pollakiuria, Constipation, Blood Glucose Decreased problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On 201210 this consumer started treatment with Levonorgestrel And Ethinyl Estradiol (dosage: Unk Df, Unk). The following drugs were being taken at the same time:
  • Symbicort (Budesonide/formoterol 160/4.5 Mcg/inh Bid)
  • Synthroid (75 Ug, Qd)
When commencing Levonorgestrel And Ethinyl Estradiol, the patient experienced the following unwanted symptoms/side effects:
  • Dehydration
  • Nausea
  • Abdominal Tenderness
  • Chills
  • Headache
  • Dysuria
  • Pollakiuria
  • Constipation
  • Blood Glucose Decreased
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as dehydration, may become evident only after a product is in use by the general population.

Hepatitis Cholestatic, Hypersensitivity
This is a report of a 18-year-old female patient (weight: NA) from DE. The patient developed the following symptoms/conditions: contraception and was treated with Levonorgestrel And Ethinyl Estradiol (dosage: NA) starting 201110. Concurrently used drugs:
  • Enalapril
  • Uro-tablinen
Soon after that, the consumer experienced the following side effects:
  • Hepatitis Cholestatic
  • Hypersensitivity
The patient was hospitalized. This opens a possibility that Levonorgestrel And Ethinyl Estradiol treatment could cause the above reactions, including hepatitis cholestatic, and some female subjects may be more susceptible.

Device Dislocation
A 33-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Levonorgestrel treatment (dosage: NA) on NS. Soon after starting Levonorgestrel treatment, the subject experienced various side effects, including:
  • Device Dislocation
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Levonorgestrel.

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Top 10 Levonorgestrel Side Effects for Women

Women Side EffectsReports
Nausea 34
Vomiting 20
Abdominal Pain 19
Pulmonary Embolism 19
Dizziness 18
Headache 18
Device Dislocation 16
Pregnancy On Oral Contraceptive 14
Abdominal Pain Upper 13
Abortion Spontaneous 13

Top 10 Levonorgestrel Side Effects for Men

Men Side EffectsReports
Congenital Naevus 1
Congenital Pyelocaliectasis 1
Foetal Exposure During Pregnancy 1
Maternal Exposure During Pregnancy 1

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Levonorgestrel Side Effects

    Did You Have a Levonorgestrel Side Effect?

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    How Effective is Levonorgestrel for You?

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    Levonorgestrel Safety Alerts, Active Ingredients, Usage Information

    NDC0378-6550
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameLEVONORGESTREL AND ETHINYL ESTRADIOL
    Nameethinyl estradiol and levonorgestrel
    Dosage FormKIT
    Route
    On market since20130816
    LabelerMylan Pharmaceuticals Inc.
    Active Ingredient(s)
    Strength(s)
    Unit(s)
    Pharma Class

    More About Levonorgestrel

    Side Effects reported to FDA: 377

    Levonorgestrel safety alerts: 2012 2002 2000

    Reported deaths: 10

    Reported hospitalizations: 50

    Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw

     

    [Posted 06/06/2012]

    AUDIENCE: Consumer, Pharmacy

    ISSUE: Sandoz notified the public that it issued a voluntary recall of 10 lots of its generic oral contraceptive Introvale in the US, following a recent report of a packaging flaw. A consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.

    The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012. 

    BACKGROUND: Introvale is an extended-cycle oral contraceptive. Sandoz is not aware of any reports of related adverse events.

    RECOMMENDATION: If a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and contact their healthcare professional.

    Healthcare professionals and patients are encouraged to report adverse events, side effects, or quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [06/05/2012 - Press Release - Sandoz]

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