NEXPLANON FDA MedWatch Direct Reports Summary

These tables and charts are created from 1,599 voluntary U.S. reports for NEXPLANON (ETONOGESTREL) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS NEXPLANON Report.

Top Adverse Effects Associated with NEXPLANON (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	DEPRESSION	251
2	WEIGHT INCREASED	173
3	HEADACHE	169
4	MOOD SWINGS	157
5	ANXIETY	145
6	FATIGUE	135
7	MENORRHAGIA	132
8	NAUSEA	114
9	BLEEDING	105
10	MIGRAINE	105
11	DIZZINESS	102
12	PAIN	100
13	VAGINAL HAEMORRHAGE	86
14	DEVICE DISLOCATION	82
15	SUICIDAL IDEATION	82
16	NUMBNESS	80
17	PAIN IN EXTREMITY	78
18	COMPLICATION ASSOCIATED WITH DEVICE	71
19	ABDOMINAL PAIN	67
20	IRREGULAR PERIODS	66
21	ACNE	61
22	MUSCLE SPASMS	59
23	HAIR LOSS	58
24	DEVICE BREAKAGE	56
25	IMPLANT SITE PAIN	56

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NEXPLANON Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
6	1547	46	1,599

Medwatch Reporter Type	Count
Consumer	1051
Physician	65
Pharmacist	26
Other Health Professional	127

Top Indications

Contraception
Product used for unknown indication
Menstrual cycle management
Palpitations
Hormonal contraception

Type of Outcome Reported
Serious: 1066
Not Serious: 533
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 1599
Concomitant Drugs: 679
Note: A single MedWatch report can list more than one drug. This summary includes NEXPLANON identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

NEXPLANON (ETONOGESTREL) Rx Drug:
FDA Safety-related Labeling Changes

Implant use expanded up to 5 years. REMS added to mitigate the risk of complications (such as infection, bleeding, pain) due to improper device insertion

Have experience (good or bad) with NEXPLANON? Rate NEXPLANON at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.