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Nexplanon Adverse Events Reported to the FDA Over Time

How are Nexplanon adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Nexplanon, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Nexplanon is flagged as the suspect drug causing the adverse event.

Most Common Nexplanon Adverse Events Reported to the FDA

What are the most common Nexplanon adverse events reported to the FDA?

Pregnancy With Implant Contraceptiv...
59 (7.31%)
No Adverse Event
54 (6.69%)
Medical Device Complication
49 (6.07%)
Abortion Spontaneous
36 (4.46%)
Device Breakage
22 (2.73%)
Drug Interaction
14 (1.73%)
Implant Site Pain
14 (1.73%)
Product Quality Issue
14 (1.73%)
Maternal Drugs Affecting Foetus
11 (1.36%)
Implant Site Pruritus
10 (1.24%)
Abortion Missed
9 (1.12%)
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Complication Of Device Insertion
9 (1.12%)
Convulsion
9 (1.12%)
Epilepsy
9 (1.12%)
Abortion Induced
8 (.99%)
Contusion
8 (.99%)
Death Neonatal
8 (.99%)
Headache
8 (.99%)
Hypersensitivity
8 (.99%)
Implant Site Reaction
8 (.99%)
Menorrhagia
8 (.99%)
Metrorrhagia
8 (.99%)
Device Dislocation
7 (.87%)
Erythema
7 (.87%)
Premature Baby
7 (.87%)
Dizziness
6 (.74%)
Drug Ineffective
6 (.74%)
Amenorrhoea
5 (.62%)
Condition Aggravated
5 (.62%)
Implant Site Erythema
5 (.62%)
Implant Site Swelling
5 (.62%)
Nausea
5 (.62%)
Pain In Extremity
5 (.62%)
Pruritus
5 (.62%)
Unintended Pregnancy
5 (.62%)
Urticaria
5 (.62%)
Vision Blurred
5 (.62%)
Aggression
4 (.5%)
Cerebral Infarction
4 (.5%)
Deep Vein Thrombosis
4 (.5%)
Depression
4 (.5%)
Dyspnoea
4 (.5%)
Erysipelas
4 (.5%)
Excessive Granulation Tissue
4 (.5%)
Fibromyalgia
4 (.5%)
Implant Site Cellulitis
4 (.5%)
Implant Site Infection
4 (.5%)
Infection
4 (.5%)
Laceration
4 (.5%)
Muscle Spasms
4 (.5%)
Off Label Use
4 (.5%)
Paraesthesia
4 (.5%)
Pyrexia
4 (.5%)
Swelling
4 (.5%)
Vaginal Haemorrhage
4 (.5%)
Vomiting
4 (.5%)
Abdominal Pain
3 (.37%)
Abortion
3 (.37%)
Angioedema
3 (.37%)
Constipation
3 (.37%)
Device Failure
3 (.37%)
Discomfort
3 (.37%)
Eczema
3 (.37%)
Feeling Abnormal
3 (.37%)
Hypoaesthesia
3 (.37%)
Implant Site Cyst
3 (.37%)
Implant Site Haematoma
3 (.37%)
Influenza Like Illness
3 (.37%)
Injury
3 (.37%)
Lip Swelling
3 (.37%)
Local Swelling
3 (.37%)
Malaise
3 (.37%)
Oxygen Saturation Decreased
3 (.37%)
Palpitations
3 (.37%)
Post Procedural Complication
3 (.37%)
Pregnancy With Contraceptive Device
3 (.37%)
Procedural Complication
3 (.37%)
Procedural Pain
3 (.37%)
Staphylococcal Infection
3 (.37%)
Treatment Noncompliance
3 (.37%)
Weight Increased
3 (.37%)
Abdominal Distension
2 (.25%)
Adverse Event
2 (.25%)
Alopecia
2 (.25%)
Anxiety
2 (.25%)
Aplastic Anaemia
2 (.25%)
Blindness Congenital
2 (.25%)
Bronchitis
2 (.25%)
Cellulitis
2 (.25%)
Cholestasis
2 (.25%)
Complication Of Device Removal
2 (.25%)
Death
2 (.25%)
Drug Hypersensitivity
2 (.25%)
Endometritis
2 (.25%)
Fallopian Tube Cyst
2 (.25%)
Fatigue
2 (.25%)
Flushing
2 (.25%)
Food Poisoning
2 (.25%)
Haematoma
2 (.25%)
Hypercoagulation
2 (.25%)
Hypoglycaemia
2 (.25%)

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This graph shows the top adverse events submitted to the FDA for Nexplanon, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Nexplanon is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Nexplanon

What are the most common Nexplanon adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Nexplanon, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Nexplanon is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Nexplanon According to Those Reporting Adverse Events

Why are people taking Nexplanon, according to those reporting adverse events to the FDA?

Contraception
163
Product Used For Unknown Indication
89
Maternal Exposure During Pregnancy
6
Maternal Drugs Affecting Foetus
3
Menstruation Irregular
2
Endometriosis
2
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Drug Labels

LabelLabelerEffective
NexplanonOrganon Pharmaceuticals USA02-MAY-12

Nexplanon Case Reports

What Nexplanon safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Nexplanon. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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