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Levonorgestrel Side Effects

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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.

Levonorgestrel Side Effects Reported to FDA



Levonorgestrel Side Effect Report#9925285
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 health 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): Pregnancy With Contraceptive Device, Maternal Exposure During Pregnancy 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.
Levonorgestrel Side Effect Report#9863454
Adnexa Uteri Mass, Ovarian Germ Cell Teratoma Benign
This report suggests a potential Levonorgestrel Adnexa Uteri Mass 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. After starting Levonorgestrel the patient began experiencing various side effects, including: Adnexa Uteri Mass, Ovarian Germ Cell Teratoma BenignAdditional 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.
Levonorgestrel Side Effect Report#9706724
Ovarian Cyst Ruptured, Ovarian Cyst, Abdominal Pain, Asthenia, Dizziness, Vaginal Discharge, Abdominal Distension
This Ovarian Cyst Ruptured 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 using Levonorgestrel, the patient experienced the following unwanted symptoms/side effects: Ovarian Cyst Ruptured, Ovarian Cyst, Abdominal Pain, Asthenia, Dizziness, Vaginal Discharge, Abdominal DistensionAlthough 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.
Levonorgestrel Side Effect Report#9652021
Pulmonary Embolism, Myocardial Infarction
This Pulmonary Embolism side effect was reported by a pharmacist from US. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Levonorgestrel (drug dosage: NA), which was initiated on
Oct 11, 2011. Concurrently used drugs: NA..After starting to take Levonorgestrel the consumer reported adverse symptoms, such as: Pulmonary Embolism, Myocardial InfarctionThese side effects may potentially be related to Levonorgestrel. The patient was hospitalized.
Levonorgestrel Side Effect Report#9631793
Hypoaesthesia
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception,asthma, who was treated with Levonorgestrel And Ethinyl Estradiol Tablets Usp (dosage: NA, start time:
Aug 11, 2013), combined with:
  • Advair (Allergies)
  • Flovent (Allergies)
and developed a serious reaction and side effect(s): Hypoaesthesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levonorgestrel And Ethinyl Estradiol Tablets Usp treatment in female patients, resulting in Hypoaesthesia side effect.
Levonorgestrel Side Effect Report#9631790
Depression
This report suggests a potential Levonorgestrel And Ethinyl Estradiol Tablets Usp Depression side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Levonorgestrel And Ethinyl Estradiol Tablets Usp (dosage: NA) starting 201308. After starting Levonorgestrel And Ethinyl Estradiol Tablets Usp the patient began experiencing various side effects, including: DepressionAdditional drugs used concurrently: NA. Although Levonorgestrel And Ethinyl Estradiol Tablets Usp demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Depression, may still occur.
Levonorgestrel Side Effect Report#9631789
Mood Altered, Crying
This Mood Altered problem was reported by a consumer or non-health professional from US. A 12-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: menstrual disorder. On 201305 this consumer started treatment with Levonorgestrel And Ethinyl Estradiol Tablets Usp (dosage: Taking 2 Tablets Daily. (strength Per Tablet 0.15 Mg/0.03 Mg)). The following drugs were being taken at the same time: NA. When using Levonorgestrel And Ethinyl Estradiol Tablets Usp, the patient experienced the following unwanted symptoms/side effects: Mood Altered, CryingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Mood Altered, may become evident only after a product is in use by the general population.
Levonorgestrel Side Effect Report#9623137
Uterine Perforation, Abdominal Pain Lower, Device Difficult To Use, Infertility Female, Ovarian Cyst
This Uterine Perforation side effect was reported by a physician from CA. A 31-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Levonorgestrel (drug dosage: 20 Mcg/24hr, Cont), which was initiated on NS. Concurrently used drugs: NA..After starting to take Levonorgestrel the consumer reported adverse symptoms, such as: Uterine Perforation, Abdominal Pain Lower, Device Difficult To Use, Infertility Female, Ovarian CystThese side effects may potentially be related to Levonorgestrel.
Levonorgestrel Side Effect Report#9516489
Uterine Perforation, Peritonitis, Sepsis
This is a report of a 28-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Levonorgestrel (dosage: Unk, Cont, start time: NS), combined with:
  • Prednisone
  • Hydroxychloroquine
and developed a serious reaction and side effect(s): Uterine Perforation, Peritonitis, Sepsis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levonorgestrel treatment in female patients, resulting in Uterine Perforation side effect. The patient was hospitalized.
Levonorgestrel Side Effect Report#9442552
Deep Vein Thrombosis
This report suggests a potential Levonorgestrel Deep Vein Thrombosis side effect(s) that can have serious consequences. A 30-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Levonorgestrel (dosage: NA) starting
Feb 01, 2013. After starting Levonorgestrel the patient began experiencing various side effects, including: Deep Vein ThrombosisAdditional drugs used concurrently:
  • Isotretinoin (60 Mg A Day Po)
Although Levonorgestrel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Deep Vein Thrombosis, may still occur.
Levonorgestrel Side Effect Report#9385864
Pregnancy With Contraceptive Device, Vaginal Haemorrhage, Maternal Exposure During Pregnancy
This Pregnancy With Contraceptive Device problem was reported by a health professional from AU. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Nov 17, 2005 this consumer started treatment with Levonorgestrel (dosage: Unk). The following drugs were being taken at the same time: NA. When using Levonorgestrel, the patient experienced the following unwanted symptoms/side effects: Pregnancy With Contraceptive Device, Vaginal Haemorrhage, Maternal Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pregnancy With Contraceptive Device, may become evident only after a product is in use by the general population.
Levonorgestrel Side Effect Report#9385857
Pregnancy With Contraceptive Device, Maternal Exposure During Pregnancy
This Pregnancy With Contraceptive Device side effect was reported by a health professional from AU. A 41-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Levonorgestrel (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Levonorgestrel the consumer reported adverse symptoms, such as: Pregnancy With Contraceptive Device, Maternal Exposure During PregnancyThese side effects may potentially be related to Levonorgestrel.
Levonorgestrel Side Effect Report#9385852
Pregnancy With Contraceptive Device, Maternal Exposure During Pregnancy
This is a report of a 41-year-old female patient (weight: NA) from AU, suffering from the following health symptoms/conditions: contraception, who was treated with Levonorgestrel (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pregnancy With Contraceptive Device, Maternal Exposure During Pregnancy 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.
Levonorgestrel Side Effect Report#9370345
Vulvovaginitis Streptococcal, Vulvovaginal Discomfort, Beta Haemolytic Streptococcal Infection, Tonsillitis, Vulvovaginal Candidiasis, Procedural Pain
This report suggests a potential Levonorgestrel (lcs, 12?g/d, 28x30) Vulvovaginitis Streptococcal side effect(s) that can have serious consequences. A 23-year-old female patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: contraception,routine health maintenance,headache,back pain and used Levonorgestrel (lcs, 12?g/d, 28x30) (dosage: 12 ?g (daily Dose), Cont, Intra-uterine) starting
Apr 20, 2010. After starting Levonorgestrel (lcs, 12?g/d, 28x30) the patient began experiencing various side effects, including: Vulvovaginitis Streptococcal, Vulvovaginal Discomfort, Beta Haemolytic Streptococcal Infection, Tonsillitis, Vulvovaginal Candidiasis, Procedural PainAdditional drugs used concurrently:
  • Inner Health Plus (1 Df (daily Dose), Bid, Oral)
  • Aspirin (600 Mg, Prn)
  • Panadeine Plus (Unk)
The patient was hospitalized. Although Levonorgestrel (lcs, 12?g/d, 28x30) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vulvovaginitis Streptococcal, may still occur.
Levonorgestrel Side Effect Report#9230554
Device Dislocation, Device Dislocation, Pregnancy With Contraceptive Device, Cervicitis Streptococcal, Escherichia Test Positive
This Device Dislocation problem was reported by a health professional from PL. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On NS this consumer started treatment with Levonorgestrel (dosage: 20 Mcg/24hr, Cont). The following drugs were being taken at the same time: NA. When using Levonorgestrel, the patient experienced the following unwanted symptoms/side effects: Device Dislocation, Device Dislocation, Pregnancy With Contraceptive Device, Cervicitis Streptococcal, Escherichia Test PositiveAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Device Dislocation, may become evident only after a product is in use by the general population.
Levonorgestrel Side Effect Report#9153458
Device Dislocation, Pregnancy With Contraceptive Device, Abdominal Pain
This Device Dislocation side effect was reported by a physician from US. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Levonorgestrel (drug dosage: Unk Unk, Cont), which was initiated on NS. Concurrently used drugs: NA..After starting to take Levonorgestrel the consumer reported adverse symptoms, such as: Device Dislocation, Pregnancy With Contraceptive Device, Abdominal PainThese side effects may potentially be related to Levonorgestrel.
Levonorgestrel Side Effect Report#9128567
Abortion Induced, Exposure During Pregnancy, Headache
This is a report of a 32-year-old female patient (weight: NA) from CZ, suffering from the following health symptoms/conditions: post coital contraception, who was treated with Levonorgestrel (dosage: NA, start time:
Dec 19, 2011), combined with: NA. and developed a serious reaction and side effect(s): Abortion Induced, Exposure During Pregnancy, Headache after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levonorgestrel treatment in female patients, resulting in Abortion Induced side effect.
Levonorgestrel Side Effect Report#9123100
Complication Of Device Insertion
This report suggests a potential Levonorgestrel Iud 52 Mg Bayer Complication Of Device Insertion side effect(s) that can have serious consequences. A 17-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception and used Levonorgestrel Iud 52 Mg Bayer (dosage: 52 Mg X1 Intra-uterine) starting
Feb 22, 2013. After starting Levonorgestrel Iud 52 Mg Bayer the patient began experiencing various side effects, including: Complication Of Device InsertionAdditional drugs used concurrently: NA. Although Levonorgestrel Iud 52 Mg Bayer demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Complication Of Device Insertion, may still occur.
Levonorgestrel Side Effect Report#9097178
Device Difficult To Use, Vaginal Haemorrhage, Complication Of Device Insertion, Procedural Pain
This Device Difficult To Use problem was reported by a consumer or non-health professional from SE. A 41-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Levonorgestrel (dosage: Unk). The following drugs were being taken at the same time: NA. When using Levonorgestrel, the patient experienced the following unwanted symptoms/side effects: Device Difficult To Use, Vaginal Haemorrhage, Complication Of Device Insertion, Procedural PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Device Difficult To Use, may become evident only after a product is in use by the general population.
Levonorgestrel Side Effect Report#9060594
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 (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Levonorgestrel the consumer reported adverse symptoms, such as: Genital Haemorrhage, Coital Bleeding, Procedural PainThese side effects may potentially be related to Levonorgestrel.
Levonorgestrel Side Effect Report#9060591
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 health 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): Device Dislocation, Device Difficult To Use 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.
Levonorgestrel Side Effect Report#9060590
Device Dislocation, Medical Device Pain
This report suggests a potential Levonorgestrel Device Dislocation 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. After starting Levonorgestrel the patient began experiencing various side effects, including: Device Dislocation, Medical Device PainAdditional 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.
Levonorgestrel Side Effect Report#9059467
Dehydration, Nausea, Abdominal Tenderness, Chills, Headache, Dysuria, Pollakiuria, Constipation, Blood Glucose Decreased
This Dehydration 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 using Levonorgestrel And Ethinyl Estradiol, the patient experienced the following unwanted symptoms/side effects: Dehydration, Nausea, Abdominal Tenderness, Chills, Headache, Dysuria, Pollakiuria, Constipation, Blood Glucose DecreasedThe 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.
Levonorgestrel Side Effect Report#9056116
Hepatitis Cholestatic, Hypersensitivity
This Hepatitis Cholestatic side effect was reported by a physician from DE. A 18-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Levonorgestrel And Ethinyl Estradiol (drug dosage: NA), which was initiated on 201110. Concurrently used drugs:
  • Enalapril
  • Uro-tablinen
.After starting to take Levonorgestrel And Ethinyl Estradiol the consumer reported adverse symptoms, such as: Hepatitis Cholestatic, HypersensitivityThese side effects may potentially be related to Levonorgestrel And Ethinyl Estradiol. The patient was hospitalized.
Levonorgestrel Side Effect Report#9017186
Device Dislocation, Device Dislocation
This is a report of a 33-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Levonorgestrel (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Device Dislocation, Device Dislocation 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.


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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.


What are common 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

What are common Levonorgestrel Side Effects for Men?

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

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

    Discuss Levonorgestrel Side Effects

    Did You Have a Levonorgestrel Side Effect?

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    How Effective is Levonorgestrel for You?

    Exceeded Expectations
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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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