Drug Safety Information for IMPLANON (Etonogestrel)

Safety-related Labeling Changes for IMPLANON (ETONOGESTREL) Rx Drug: FDA Link

Adverse Drug Reactions for IMPLANON* (Etonogestrel)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with IMPLANON
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Device difficult to use2845
2Product quality issue1996
3Medical device complication1928
4Device breakage1603
5Menorrhagia1051
6Metrorrhagia960
7Unintended pregnancy878
8Device deployment issue847
9Device dislocation818
10Incorrect drug administration duration817
11Menstruation irregular*813
12Weight increased*779
13Amenorrhoea766
14Implant site pain757
15Headache*742
16Device kink696
17Haemorrhage*575
18Pain in extremity522
19Device expulsion521
20Nausea491

* This side effect also appears in "Top 10 Side Effects of IMPLANON " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking IMPLANON
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Contraception*29447
2Product used for unknown indication2051
3Menstrual cycle management240
4Menstruation irregular151
5Endometriosis110
6Menstrual disorder76
7Maternal exposure during pregnancy71
8Menorrhagia49
9Ovarian cyst30
10Maternal drugs affecting foetus25

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for IMPLANON

Total Reports Filed with FDA: 46713


Number of FDA Adverse Event Reports by Patient Age for IMPLANON

Total Reports Filed with FDA: 46713*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Etonogestrel (Implanon, Nexplanon)

Charts are based on 46713 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and IMPLANON Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.