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Paragard Side Effects

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.

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.

Paragard Side Effects Reported to FDA

The following 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.


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.
Device Dislocation
This is a report of a 22-year-old female patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Device Dislocation
which developed 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.

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. Soon after starting Paragard 380a the patient began experiencing various side effects, including:
  • Device Dislocation
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.

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 commencing Paragard 380a, the patient experienced the following unwanted symptoms/side effects:
  • Device Expulsion
Although 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.

Pollakiuria, Metrorrhagia, Abdominal Pain, Dyspareunia, Device Expulsion
This is a report of a 41-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: contraception and was treated with Paragard 380a (dosage: NA) starting Jan 31, 2014. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Pollakiuria
  • Metrorrhagia
  • Abdominal Pain
  • Dyspareunia
  • Device Expulsion
This opens a possibility that Paragard 380a treatment could cause the above reactions, including pollakiuria, and some female subjects may be more susceptible.


Device Expulsion
A 23-year-old female patient (weight: NA) from US with the following symptoms/conditions: contraception started Paragard 380a treatment (dosage: NA) on Feb 07, 2014. Soon after starting Paragard 380a treatment, the subject experienced various side effects, including:
  • Device Expulsion
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Paragard 380a.

Abortion Spontaneous, Pregnancy With Contraceptive Device, Activities Of Daily Living Impaired, Nausea, Vomiting, Vaginal Haemorrhage, Pain
A 32-year-old female patient from US (weight: NA) experienced symptoms, such as: contraception and was treated with Paragard 380a(dosage: NA). The treatment was initiated on 2008. After that a consumer reported the following side effect(s):
  • Abortion Spontaneous
  • Pregnancy With Contraceptive Device
  • Activities Of Daily Living Impaired
  • Nausea
  • Vomiting
  • Vaginal Haemorrhage
  • Pain
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Paragard 380a efficacy: NA.

Device Dislocation, Pelvic Pain
In this report, Paragard 380a was administered for the following condition: contraception,migraine.A 26-year-old female consumer from US (weight: NA) started Paragard 380a treatment (dosage: NA) on Dec 12, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Device Dislocation
  • Pelvic Pain
A possible interaction with other drugs could have contributed to this reaction:
  • Topiramate
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Paragard 380a treatment could be related to the listed above side effect(s).

Device Expulsion
This is a report of the following Paragard 380a side effect(s):
  • Device Expulsion
A female patient from US (weight: NA) presented with the following condition: contraception and received a treatment with Paragard 380a (dosage: NA) starting: 201306.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Paragard 380a treatment could be associated with the listed above side effect(s).

Device Dislocation, Pain
This Paragard 380a report was submitted by a 29-year-old female consumer from US (weight: NA). The patient was diagnosed with: contraception and Paragard 380a was administered (dosage: NA) starting: Feb 19, 2014. The consumer developed a set of symptoms:
  • Device Dislocation
  • Pain
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Paragard 380a treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Vaginal Haemorrhage, Nausea, Fatigue, Abortion Induced, Pregnancy With Contraceptive Device
This is a report of a possible correlation between Paragard use and the following symptoms/side effect(s):
  • Vaginal Haemorrhage
  • Nausea
  • Fatigue
  • Abortion Induced
  • Pregnancy With Contraceptive Device
which could contribute to an assessment of Paragard risk profile.A 32-year-old female consumer from US (weight: NA) was suffering from contraception and was treated with Paragard (dosage: NA) starting 2008.Other concurrent medications: NA.The patient was hospitalized.

Device Dislocation
A 21-year-old female patient from US (weight: NA) presented with the following symptoms: contraception and after a treatment with Paragard 380a (dosage: NA) experienced the following side effect(s):
  • Device Dislocation
The treatment was started on Nov 27, 2013. Paragard 380a was used in combination with the following drugs: NA.This report could alert potential Paragard 380a consumers.

Device Dislocation
In this report, a 28-year-old female patient from US (weight: NA) was affected by a possible Paragard 380a side effect.The patient was diagnosed with contraception. After a treatment with Paragard 380a (dosage: NA, start date: Dec 02, 2013), the patient experienced the following side effect(s):
  • Device Dislocation
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 Paragard 380a treatment.

Embedded Device, Uterine Leiomyoma, Medical Device Complication
This is a report of a 46-year-old female patient from US (weight: NA), who used Paragard 380a (dosage: NA) for a treatment of contraception. After starting a treatment on 2004, the patient experienced the following side effect(s):
  • Embedded Device
  • Uterine Leiomyoma
  • Medical Device Complication
The following drugs could possibly have interacted with the Paragard 380a treatment NA.Taken together, these observations suggest that a Paragard 380a treatment could be related to side effect(s), such as Embedded Device, Uterine Leiomyoma, Medical Device Complication.

Device Dislocation
This device dislocation 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. The patient was prescribed Paragard 380a (dosage: NA), which was started on Feb 06, 2014. Concurrently used drugs: NA. When starting to take Paragard 380a the consumer reported the following symptoms:
  • Device Dislocation
These side effects may potentially be related to Paragard 380a.

Vulvovaginal Pain, Device Expulsion
This is a Paragard 380a side effect report of a 47-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: contraception, who was treated with Paragard 380a (dosage:NA, start time: Feb 03, 2014), combined with: NA., and developed a serious reaction and a vulvovaginal pain side effect. The patient presented with:
  • Vulvovaginal Pain
  • Device Expulsion
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Paragard 380a treatment in female patients suffering from contraception, resulting in vulvovaginal pain.

Device Dislocation, Vaginal Haemorrhage, Pelvic Pain
This report suggests a potential Paragard 380a 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): contraception and used Paragard 380a (dosage: NA) starting 2014. Soon after starting Paragard 380a the patient began experiencing various side effects, including:
  • Device Dislocation
  • Vaginal Haemorrhage
  • Pelvic Pain
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.

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 medical condition(s): contraception.On Feb 04, 2014 a consumer started treatment with Paragard 380a (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Paragard 380a, the patient experienced the following unwanted symptoms /side effects:
  • Device Expulsion
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as device expulsion, may become evident only after a product is in use by the general population.

Menorrhagia
This is a Paragard 380a side effect report of a 32-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: contraception,insomnia and was treated with Paragard 380a (dosage: NA) starting Oct 08, 2013. Concurrently used drugs:
  • Ambien
Soon after that, the consumer experienced the following of symptoms:
  • Menorrhagia
This opens a possibility that Paragard 380a could cause menorrhagia and that some female patients may be more susceptible.

Pelvic Pain
A 43-year-old female patient (weight: NA) from US with the following symptoms: contraception started Paragard 380a treatment (dosage: NA) on Mar 04, 2014. Soon after starting Paragard 380a treatment, the consumer experienced several side effects, including:
  • Pelvic Pain
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Paragard 380a side effects, such as pelvic pain.

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 (dosage: NA), which was started on Dec 18, 2013. Concurrently used drugs:
  • Norvasc
.When starting to take Paragard 380a the consumer reported symptoms, such as:
  • Device Dislocation
These side effects may potentially be related to Paragard 380a.

Device Dislocation
This is a report of a 29-year-old female patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Device Dislocation
which developed 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.

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. Soon after starting Paragard 380a the patient began experiencing various side effects, including:
  • Device Expulsion
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.

Muscle Spasms, Vaginal Haemorrhage, Device Expulsion
This Muscle Spasms, Vaginal Haemorrhage, Device Expulsion 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 commencing Paragard 380a, the patient experienced the following unwanted symptoms/side effects:
  • Muscle Spasms
  • Vaginal Haemorrhage
  • Device Expulsion
Although 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.

Device Expulsion
This is a report of a 16-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: contraception,muscle spasms,convulsion and was treated with Paragard 380a (dosage: NA) starting Dec 16, 2013. Concurrently used drugs:
  • Motrin
  • Trileptal
Soon after that, the consumer experienced the following side effects:
  • Device Expulsion
This opens a possibility that Paragard 380a treatment could cause the above reactions, including device expulsion, and some female subjects may be more susceptible.

Device Expulsion
A 25-year-old female patient (weight: NA) from US with the following symptoms/conditions: contraception started Paragard 380a treatment (dosage: NA) on Feb 21, 2014. Soon after starting Paragard 380a treatment, the subject experienced various side effects, including:
  • Device Expulsion
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Paragard 380a.

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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 Paragard Side Effects

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    How Effective is Paragard for You?

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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