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Paragard Side Effects

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Common Paragard Side Effects


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

Device Expulsion (2137)
Device Dislocation (1246)
Metrorrhagia (525)
Menorrhagia (487)
Pelvic Pain (423)
Abdominal Pain (355)
Vaginal Haemorrhage (312)
Medical Device Complication (287)
Pregnancy With Contraceptive Device (241)
Pain (204)
Muscle Spasms (198)
Embedded Device (166)
Dysmenorrhoea (160)
Vaginal Discharge (146)
Device Breakage (133)
Dyspareunia (128)
Menstruation Delayed (95)
Uterine Spasm (94)
Abdominal Pain Lower (88)
Back Pain (88)

➢ 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.

Paragard Side Effects Reported to FDA



Paragard Side Effect Report#9999795
Device Dislocation
This is a report of a 22-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: post coital contraception,attention deficit/hyperactivity disorder, who was treated with Paragard 380a (dosage: NA, start time:
Feb 20, 2014), combined with:
  • Adderall
and developed a serious reaction and side effect(s): Device Dislocation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paragard 380a treatment in female patients, resulting in Device Dislocation side effect.
Paragard Side Effect Report#9997892
Device Dislocation
This report suggests a potential Paragard 380a Device Dislocation side effect(s) that can have serious consequences. A 31-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception and used Paragard 380a (dosage: NA) starting
Jan 02, 2014. After starting Paragard 380a the patient began experiencing various side effects, including: Device DislocationAdditional drugs used concurrently: NA. Although Paragard 380a demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Device Dislocation, may still occur.
Paragard Side Effect Report#9997179
Device Expulsion
This Device Expulsion problem was reported by a health professional from US. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Jan 13, 2014 this consumer started treatment with Paragard 380a (dosage: NA). The following drugs were being taken at the same time: NA. When using Paragard 380a, 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.
Paragard Side Effect Report#9997173
Pollakiuria, Metrorrhagia, Abdominal Pain, Dyspareunia, Device Expulsion
This Pollakiuria side effect was reported by a health professional from US. A 41-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Paragard 380a (drug dosage: NA), which was initiated on
Jan 31, 2014. Concurrently used drugs: NA..After starting to take Paragard 380a the consumer reported adverse symptoms, such as: Pollakiuria, Metrorrhagia, Abdominal Pain, Dyspareunia, Device ExpulsionThese side effects may potentially be related to Paragard 380a.
Paragard Side Effect Report#9997171
Device Expulsion
This is a report of a 23-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Paragard 380a (dosage: NA, start time:
Feb 07, 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 Paragard 380a treatment in female patients, resulting in Device Expulsion side effect.
Paragard Side Effect Report#9996642
Abortion Spontaneous, Pregnancy With Contraceptive Device, Activities Of Daily Living Impaired, Nausea, Vomiting, Vaginal Haemorrhage, Pain
This report suggests a potential Paragard 380a Abortion Spontaneous side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception and used Paragard 380a (dosage: NA) starting 2008. After starting Paragard 380a the patient began experiencing various side effects, including: Abortion Spontaneous, Pregnancy With Contraceptive Device, Activities Of Daily Living Impaired, Nausea, Vomiting, Vaginal Haemorrhage, PainAdditional drugs used concurrently: NA. Although Paragard 380a demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abortion Spontaneous, may still occur.
Paragard Side Effect Report#9996561
Device Dislocation, Pelvic Pain
This Device Dislocation problem was reported by a health professional from US. A 26-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception,migraine. On
Dec 12, 2013 this consumer started treatment with Paragard 380a (dosage: NA). The following drugs were being taken at the same time:
  • Topiramate
When using Paragard 380a, the patient experienced the following unwanted symptoms/side effects: Device Dislocation, Pelvic PainAlthough 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.
Paragard Side Effect Report#9995788
Device Expulsion
This Device Expulsion side effect was reported by a health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Paragard 380a (drug dosage: NA), which was initiated on 201306. Concurrently used drugs: NA..After starting to take Paragard 380a the consumer reported adverse symptoms, such as: Device ExpulsionThese side effects may potentially be related to Paragard 380a.
Paragard Side Effect Report#9995528
Device Dislocation, Pain
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 Paragard 380a (dosage: NA, start time:
Feb 19, 2014), combined with: NA. and developed a serious reaction and side effect(s): Device Dislocation, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paragard 380a treatment in female patients, resulting in Device Dislocation side effect.
Paragard Side Effect Report#9994767
Vaginal Haemorrhage, Nausea, Fatigue, Abortion Induced, Pregnancy With Contraceptive Device
This report suggests a potential Paragard Vaginal Haemorrhage side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception and used Paragard (dosage: NA) starting 2008. After starting Paragard the patient began experiencing various side effects, including: Vaginal Haemorrhage, Nausea, Fatigue, Abortion Induced, Pregnancy With Contraceptive DeviceAdditional drugs used concurrently: NA.The patient was hospitalized. Although Paragard demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vaginal Haemorrhage, may still occur.
Paragard Side Effect Report#9992859
Device Dislocation
This Device Dislocation problem was reported by a health professional from US. A 21-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Nov 27, 2013 this consumer started treatment with Paragard 380a (dosage: NA). The following drugs were being taken at the same time: NA. When using Paragard 380a, 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.
Paragard Side Effect Report#9992790
Device Dislocation
This Device Dislocation side effect was reported by a health professional from US. A 28-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Paragard 380a (drug dosage: NA), which was initiated on
Dec 02, 2013. Concurrently used drugs: NA..After starting to take Paragard 380a the consumer reported adverse symptoms, such as: Device DislocationThese side effects may potentially be related to Paragard 380a.
Paragard Side Effect Report#9992566
Embedded Device, Uterine Leiomyoma, Medical Device Complication
This is a report of a 46-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Paragard 380a (dosage: NA, start time: 2004), combined with: NA. and developed a serious reaction and side effect(s): Embedded Device, Uterine Leiomyoma, Medical Device Complication after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paragard 380a treatment in female patients, resulting in Embedded Device side effect.
Paragard Side Effect Report#9991942
Device Dislocation
This report suggests a potential Paragard 380a Device Dislocation side effect(s) that can have serious consequences. A 25-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception and used Paragard 380a (dosage: NA) starting
Feb 06, 2014. After starting Paragard 380a the patient began experiencing various side effects, including: Device DislocationAdditional drugs used concurrently: NA. Although Paragard 380a demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Device Dislocation, may still occur.
Paragard Side Effect Report#9991524
Vulvovaginal Pain, Device Expulsion
This Vulvovaginal Pain problem was reported by a health professional from US. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Feb 03, 2014 this consumer started treatment with Paragard 380a (dosage: NA). The following drugs were being taken at the same time: NA. When using Paragard 380a, the patient experienced the following unwanted symptoms/side effects: Vulvovaginal Pain, Device ExpulsionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Vulvovaginal Pain, may become evident only after a product is in use by the general population.
Paragard Side Effect Report#9986570
Device Dislocation, Vaginal Haemorrhage, Pelvic Pain
This Device Dislocation side effect was reported by a health professional from US. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception.The patient was prescribed Paragard 380a (drug dosage: NA), which was initiated on 2014. Concurrently used drugs: NA..After starting to take Paragard 380a the consumer reported adverse symptoms, such as: Device Dislocation, Vaginal Haemorrhage, Pelvic PainThese side effects may potentially be related to Paragard 380a.
Paragard Side Effect Report#9985571
Device Expulsion
This is a report of a 32-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Paragard 380a (dosage: NA, start time:
Feb 04, 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 Paragard 380a treatment in female patients, resulting in Device Expulsion side effect.
Paragard Side Effect Report#9985521
Menorrhagia
This report suggests a potential Paragard 380a Menorrhagia side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception,insomnia and used Paragard 380a (dosage: NA) starting
Oct 08, 2013. After starting Paragard 380a the patient began experiencing various side effects, including: MenorrhagiaAdditional drugs used concurrently:
  • Ambien
Although Paragard 380a demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Menorrhagia, may still occur.
Paragard Side Effect Report#9985501
Pelvic Pain
This Pelvic Pain problem was reported by a health professional from US. A 43-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Mar 04, 2014 this consumer started treatment with Paragard 380a (dosage: NA). The following drugs were being taken at the same time: NA. When using Paragard 380a, the patient experienced the following unwanted symptoms/side effects: Pelvic PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pelvic Pain, may become evident only after a product is in use by the general population.
Paragard Side Effect Report#9984567
Device Dislocation
This Device Dislocation side effect was reported by a health professional from US. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception,hypertension.The patient was prescribed Paragard 380a (drug dosage: NA), which was initiated on
Dec 18, 2013. Concurrently used drugs:
  • Norvasc
.After starting to take Paragard 380a the consumer reported adverse symptoms, such as: Device DislocationThese side effects may potentially be related to Paragard 380a.
Paragard Side Effect Report#9983860
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 Paragard 380a (dosage: NA, start time:
Feb 17, 2014), combined with: NA. and developed a serious reaction and side effect(s): Device Dislocation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paragard 380a treatment in female patients, resulting in Device Dislocation side effect.
Paragard Side Effect Report#9983597
Device Expulsion
This report suggests a potential Paragard 380a Device Expulsion side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: contraception,insomnia and used Paragard 380a (dosage: NA) starting
Mar 24, 2011. After starting Paragard 380a the patient began experiencing various side effects, including: Device ExpulsionAdditional drugs used concurrently:
  • Ambien
Although Paragard 380a demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Device Expulsion, may still occur.
Paragard Side Effect Report#9983483
Muscle Spasms, Vaginal Haemorrhage, Device Expulsion
This Muscle Spasms problem was reported by a health professional from US. A 29-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: contraception. On
Jan 21, 2014 this consumer started treatment with Paragard 380a (dosage: NA). The following drugs were being taken at the same time: NA. When using Paragard 380a, the patient experienced the following unwanted symptoms/side effects: Muscle Spasms, Vaginal Haemorrhage, Device ExpulsionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Spasms, may become evident only after a product is in use by the general population.
Paragard Side Effect Report#9983425
Device Expulsion
This Device Expulsion side effect was reported by a health professional from US. A 16-year-old female patient (weight:NA) experienced the following symptoms/conditions: contraception,muscle spasms,convulsion.The patient was prescribed Paragard 380a (drug dosage: NA), which was initiated on
Dec 16, 2013. Concurrently used drugs:
  • Motrin
  • Trileptal
.After starting to take Paragard 380a the consumer reported adverse symptoms, such as: Device ExpulsionThese side effects may potentially be related to Paragard 380a.
Paragard Side Effect Report#9973817
Device Expulsion
This is a report of a 25-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: contraception, who was treated with Paragard 380a (dosage: NA, start time:
Feb 21, 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 Paragard 380a treatment in female patients, resulting in Device Expulsion side effect.


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The appearance of Paragard 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.

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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.

    Paragard 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.

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    Discuss Paragard Side Effects

    Did You Have a Paragard Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Paragard for You?

    Exceeded Expectations
    Effective
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    Paragard Safety Alerts, Active Ingredients, Usage Information

    NDC51285-204
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameParaGard T 380A
    Namecopper
    Dosage FormINTRAUTERINE DEVICE
    RouteINTRAUTERINE
    On market since20040101
    LabelerTeva Women's Health, Inc.
    Active Ingredient(s)COPPER
    Strength(s)313.4
    Unit(s)mg/1
    Pharma ClassCopper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implant

    More About Paragard

    Side Effects reported to FDA: 4693

    Paragard safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 78

    Latest Paragard clinical trials