Common Mirena Side Effects


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

Device Expulsion (12203)
Device Dislocation (4760)
Vaginal Haemorrhage (3382)
Abdominal Pain (3195)
Pregnancy With Contraceptive Device (2959)
Intra-uterine Contraceptive Device Expelled (2461)
Abdominal Pain Lower (2324)
Procedural Pain (2261)
Pain (2202)
Genital Haemorrhage (2193)
Uterine Perforation (2155)
Iucd Complication (2016)
Amenorrhoea (1911)
Pelvic Pain (1296)
Menorrhagia (1257)
Uterine Rupture (1152)
Nausea (1150)
Device Difficult To Use (1079)
Headache (999)
Post Procedural Haemorrhage (978)

➢ 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.

Mirena Side Effects Reported to FDA



Mirena Side Effect Report#9999240
Insomnia, Anxiety
This is a report of a 35-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Mirena Iud (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Insomnia, Anxiety after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirena Iud treatment in female patients, resulting in Insomnia side effect.
Mirena Side Effect Report#9999197
Pruritus, Anal Pruritus, Depression, Mood Swings, Middle Ear Effusion, Insomnia, Arthralgia, Nausea, Influenza Like Illness
This report suggests a potential Mirena Iud Pruritus side effect(s) that can have serious consequences. A 36-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Mirena Iud (dosage: NA) starting NS. After starting Mirena Iud the patient began experiencing various side effects, including: Pruritus, Anal Pruritus, Depression, Mood Swings, Middle Ear Effusion, Insomnia, Arthralgia, Nausea, Influenza Like IllnessAdditional drugs used concurrently: NA. Although Mirena Iud demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pruritus, may still occur.
Mirena Side Effect Report#9996088
Device Dislocation
This Device Dislocation problem was reported by a consumer or non-health professional from US. A 29-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Jan 28, 2014 this consumer started treatment with Mirena (dosage: 20 Mcg/24hr, Cont). The following drugs were being taken at the same time: NA. When using Mirena, the patient experienced the following unwanted symptoms/side effects: Device DislocationAlthough 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.
Mirena Side Effect Report#9995600
Device Issue, Device Deployment Issue, Discomfort
This Device Issue side effect was reported by a physician from US. A 35-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Mirena (drug dosage: 20 Mcg/24hr, Cont), which was initiated on
Mar 04, 2014. Concurrently used drugs: NA..After starting to take Mirena the consumer reported adverse symptoms, such as: Device Issue, Device Deployment Issue, DiscomfortThese side effects may potentially be related to Mirena.
Mirena Side Effect Report#9995592
Cyst, Muscle Spasms, Device Dislocation
This is a report of a 29-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Mirena Iud (dosage: NA, start time:
May 10, 2012), combined with:
  • Prenatal Vitamins
and developed a serious reaction and side effect(s): Cyst, Muscle Spasms, Device Dislocation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirena Iud treatment in female patients, resulting in Cyst side effect. The patient was hospitalized and became disabled.
Mirena Side Effect Report#9995374
Device Expulsion
This report suggests a potential Mirena Device Expulsion side effect(s) that can have serious consequences. A 23-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception and used Mirena (dosage: 20 Mcg/24hr, Cont) starting
Nov 14, 2013. After starting Mirena the patient began experiencing various side effects, including: Device ExpulsionAdditional drugs used concurrently: NA. Although Mirena demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Device Expulsion, may still occur.
Mirena Side Effect Report#9995329
Device Dislocation, Device Deployment Issue
This Device Dislocation problem was reported by a consumer or non-health professional from US. A 42-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: menorrhagia,contraception. On
Jan 10, 2014 this consumer started treatment with Mirena (dosage: 20 Mcg/24hr, Cont). The following drugs were being taken at the same time: NA. When using Mirena, the patient experienced the following unwanted symptoms/side effects: Device Dislocation, Device Deployment IssueAlthough 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.
Mirena Side Effect Report#9995325
Uterine Perforation, Device Issue, Abdominal Pain, Depression, Anxiety, Injury, Pain, Emotional Distress
This Uterine Perforation side effect was reported by a consumer or non-health professional from US. A 25-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception,dysfunctional uterine bleeding.The patient was prescribed Mirena (drug dosage: 20 Mcg/24hr, Unk), which was initiated on
Jan 18, 2012. Concurrently used drugs: NA..After starting to take Mirena the consumer reported adverse symptoms, such as: Uterine Perforation, Device Issue, Abdominal Pain, Depression, Anxiety, Injury, Pain, Emotional DistressThese side effects may potentially be related to Mirena. The patient was hospitalized.
Mirena Side Effect Report#9995322
Embedded Device, Device Dislocation
This is a report of a 30-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Mirena (dosage: 20 Mcg/24hr, Cont, start time: 201004), combined with: NA. and developed a serious reaction and side effect(s): Embedded Device, Device Dislocation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirena treatment in female patients, resulting in Embedded Device side effect.
Mirena Side Effect Report#9995252
Device Expulsion
This report suggests a potential Mirena Device Expulsion side effect(s) that can have serious consequences. A 21-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception and used Mirena (dosage: 20 Mcg/24hr, Cont) starting
Jan 16, 2014. After starting Mirena the patient began experiencing various side effects, including: Device ExpulsionAdditional drugs used concurrently: NA. Although Mirena demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Device Expulsion, may still occur.
Mirena Side Effect Report#9995251
Uterine Pain, Ovulation Pain, Genital Discharge, Vaginal Discharge, Therapeutic Response Unexpected
This Uterine Pain problem was reported by a consumer or non-health professional from US. A 42-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Feb 23, 2009 this consumer started treatment with Mirena (dosage: Unk). The following drugs were being taken at the same time: NA. When using Mirena, the patient experienced the following unwanted symptoms/side effects: Uterine Pain, Ovulation Pain, Genital Discharge, Vaginal Discharge, Therapeutic Response UnexpectedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Uterine Pain, may become evident only after a product is in use by the general population.
Mirena Side Effect Report#9995250
Post Procedural Discomfort, Device Difficult To Use
This Post Procedural Discomfort side effect was reported by a consumer or non-health professional from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Mirena (drug dosage: 20 ?g/d, Cont), which was initiated on
Feb 20, 2014. Concurrently used drugs: NA..After starting to take Mirena the consumer reported adverse symptoms, such as: Post Procedural Discomfort, Device Difficult To UseThese side effects may potentially be related to Mirena.
Mirena Side Effect Report#9995248
Device Expulsion
This is a report of a 43-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Mirena (dosage: 20 Mcg/24hr, Cont, start time:
Feb 10, 2014), combined with: NA. and developed a serious reaction and side effect(s): Device Expulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirena treatment in female patients, resulting in Device Expulsion side effect.
Mirena Side Effect Report#9995247
Device Expulsion
This report suggests a potential Mirena Device Expulsion side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception and used Mirena (dosage: 20 Mcg/24hr, Cont) starting
Dec 04, 2013. After starting Mirena the patient began experiencing various side effects, including: Device ExpulsionAdditional drugs used concurrently: NA. Although Mirena demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Device Expulsion, may still occur.
Mirena Side Effect Report#9995242
Device Expulsion, Abdominal Pain Lower
This Device Expulsion problem was reported by a consumer or non-health professional from US. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Oct 10, 2013 this consumer started treatment with Mirena (dosage: 20 Mcg/24hr, Cont). The following drugs were being taken at the same time: NA. When using Mirena, the patient experienced the following unwanted symptoms/side effects: Device Expulsion, Abdominal Pain LowerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Device Expulsion, may become evident only after a product is in use by the general population.
Mirena Side Effect Report#9992892
Post Procedural Haemorrhage, Pain
This Post Procedural Haemorrhage side effect was reported by a consumer or non-health professional from US. A 15-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Mirena (drug dosage: 20 Mcg/24hr, Cont), which was initiated on 2014. Concurrently used drugs: NA..After starting to take Mirena the consumer reported adverse symptoms, such as: Post Procedural Haemorrhage, PainThese side effects may potentially be related to Mirena.
Mirena Side Effect Report#9992840
Device Expulsion
This is a report of a 41-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception,menorrhagia, who was treated with Mirena (dosage: 20 ?g/d, Cont, start time:
Jan 08, 2014), combined with: NA. and developed a serious reaction and side effect(s): Device Expulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirena treatment in female patients, resulting in Device Expulsion side effect.
Mirena Side Effect Report#9992836
Abortion, Genital Haemorrhage, Pregnancy With Contraceptive Device
This report suggests a potential Mirena Abortion side effect(s) that can have serious consequences. A 19-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Mirena (dosage: Unk) starting 201306. After starting Mirena the patient began experiencing various side effects, including: Abortion, Genital Haemorrhage, Pregnancy With Contraceptive DeviceAdditional drugs used concurrently: NA. Although Mirena demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abortion, may still occur.
Mirena Side Effect Report#9992625
Abdominal Rigidity, Device Expulsion
This Abdominal Rigidity problem was reported by a consumer or non-health professional from US. A 31-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Mar 05, 2014 this consumer started treatment with Mirena (dosage: 20 Mcg/24hr, Cont). The following drugs were being taken at the same time: NA. When using Mirena, the patient experienced the following unwanted symptoms/side effects: Abdominal Rigidity, Device ExpulsionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Rigidity, may become evident only after a product is in use by the general population.
Mirena Side Effect Report#9992608
Device Expulsion
This Device Expulsion side effect was reported by a consumer or non-health professional from US. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Mirena (drug dosage: 20 Mcg/24hr, Cont), which was initiated on
Jan 10, 2014. Concurrently used drugs: NA..After starting to take Mirena the consumer reported adverse symptoms, such as: Device ExpulsionThese side effects may potentially be related to Mirena.
Mirena Side Effect Report#9992595
Device Expulsion
This is a report of a 36-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception,menorrhagia, who was treated with Mirena (dosage: 20 Mcg/24hr, Cont, start time:
Apr 30, 2013), combined with: NA. and developed a serious reaction and side effect(s): Device Expulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirena treatment in female patients, resulting in Device Expulsion side effect.
Mirena Side Effect Report#9992571
Procedural Pain, Device Difficult To Use
This report suggests a potential Mirena Procedural Pain side effect(s) that can have serious consequences. A 38-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception and used Mirena (dosage: 20 Mcg/24hr, Cont) starting
Mar 03, 2014. After starting Mirena the patient began experiencing various side effects, including: Procedural Pain, Device Difficult To UseAdditional drugs used concurrently: NA. Although Mirena demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Procedural Pain, may still occur.
Mirena Side Effect Report#9992555
Device Expulsion
This Device Expulsion problem was reported by a consumer or non-health professional from US. A 41-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Feb 14, 2014 this consumer started treatment with Mirena (dosage: 20 Mcg/24hr, Cont). The following drugs were being taken at the same time: NA. When using Mirena, the patient experienced the following unwanted symptoms/side effects: Device ExpulsionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Device Expulsion, may become evident only after a product is in use by the general population.
Mirena Side Effect Report#9991632
Cervical Dysplasia
This Cervical Dysplasia side effect was reported by a consumer or non-health professional from US. A 39-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Mirena (drug dosage: 20 Mcg/24hr, Cont), which was initiated on
Nov 08, 2013. Concurrently used drugs: NA..After starting to take Mirena the consumer reported adverse symptoms, such as: Cervical DysplasiaThese side effects may potentially be related to Mirena.
Mirena Side Effect Report#9991630
Device Dislocation, Device Difficult To Use, Device Misuse
This is a report of a 35-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Mirena (dosage: 20 Mcg/24hr, Cont, start time: 2008), combined with: NA. and developed a serious reaction and side effect(s): Device Dislocation, Device Difficult To Use, Device Misuse after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirena treatment in female patients, resulting in Device Dislocation side effect.


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The appearance of Mirena 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 Mirena Side Effects for Women?

Women Side Effects Reports
Device Expulsion 12189
Device Dislocation 4746
Vaginal Haemorrhage 3374
Abdominal Pain 3188
Pregnancy With Contraceptive Device 2956
Intra-uterine Contraceptive Device Expelled 2459
Abdominal Pain Lower 2322
Procedural Pain 2257
Pain 2199
Genital Haemorrhage 2190

What are common Mirena Side Effects for Men?

Men Side Effects Reports
Penile Pain 23
Genital Pain 16
Premature Baby 12
Foetal Growth Retardation 8
Small For Dates Baby 8
Apgar Score Low 5
Caesarean Section 5
Device Dislocation 4
Dyspareunia 4
Penis Injury 4

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.

    Mirena 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 Mirena Side Effects

    Did You Have a Mirena Side Effect?

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    Mirena Safety Alerts, Active Ingredients, Usage Information

    NDC 50419-421
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Mirena
    Name Levonorgestrel
    Dosage Form INTRAUTERINE DEVICE
    Route INTRAUTERINE
    On market since 20091001
    Labeler Bayer HealthCare Pharmaceuticals Inc.
    Active Ingredient(s) LEVONORGESTREL
    Strength(s) 52
    Unit(s) mg/1
    Pharma Class Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners

    Mirena Dosage, Warnings, Usage.

    Side Effects reported to FDA: 41254

    Mirena safety alerts: No

    Reported deaths: 60

    Reported hospitalizations: 4282

    Latest Mirena clinical trials

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