Pharmacologic class (EPC) · 17 drug pages

Progestin: adverse event reports filed with FDA

293,492 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

293,492
reports across the class: 1.4% of all reports; 19,262
reports, 12 months to June 2026: 10,187 in the 12 months before; 41.9%
marked serious by the reporter: 57.4% across all reports; 17
drugs with a page: brand and generic names counted separately

Progestin is a pharmacologic class (an FDA Established Pharmacologic Class) with 17 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 293,492 adverse event reports received by FDA, 1.4% of the database, from January 2004 to June 2026.

19,262 reports arrived in the 12 months to June 2026, up 89% from 10,187 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 41.9% of the class's reports are marked serious, 0.4% record death among the outcomes and 5.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are device expulsion (16.3%), device dislocation (7.9%) and vaginal haemorrhage (6%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
MirenaLevonorgestrel	brand	129,479	3,433	40.6%	Device expulsion
NexplanonEtonogestrel	brand	43,751	836	24.8%	No adverse event
Plan B One-StepLevonorgestrel	brand	35,324	327	4.9%	Menstruation irregular
ProveraMedroxyprogesterone acetate	brand	20,400	26	98.6%	Breast cancer female
Depo-ProveraMedroxyprogesterone acetate	brand	18,669	11,383	87.1%	Meningioma
LilettaLevonorgestrel	brand	10,567	850	8.2%	Device expulsion
Medroxyprogesterone acetate	generic	8,621	818	89%	Breast cancer female
KyleenaLevonorgestrel	brand	8,075	694	40.4%	Device expulsion
SkylaLevonorgestrel	brand	5,310	125	41.7%	Device expulsion
Medroxyprogesterone	generic	3,030	165	73.8%	Breast cancer
Levonorgestrel	generic	2,711	219	72.2%	Drug ineffective
Take ActionLevonorgestrel	brand	2,550	20	8.1%	Vaginal haemorrhage
Etonogestrel	generic	2,112	255	89.7%	Pregnancy with implant contraceptive
AfteraLevonorgestrel	brand	818	19	5%	Vaginal haemorrhage
Norethindrone	generic	797	52	52.1%	Off label use
Norethindrone acetate	generic	722	8	35.9%	Hot flush
Megestrol acetate	generic	556	32	79.9%	Deep vein thrombosis

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Device expulsionthe device came out16.3%47,696
Device dislocationthe device moved out of position7.9%23,085
Vaginal haemorrhagevaginal bleeding6%17,538
Menstruation irregularirregular periods5.8%17,137
Breast cancer female4.5%13,226
Meningioma4.2%12,293
Genital haemorrhage3.8%11,132
Breast cancerbreast cancer3.7%10,957
No adverse eventno adverse event was reported3.6%10,709
Nauseafeeling sick3.3%9,652
Abdominal pain lower3.2%9,410
Abdominal painstomach or belly pain3.2%9,286
Complication of device insertion3%8,926
Device difficult to usethe device was hard to use3%8,764
Painpain, site not specified2.9%8,574
Procedural painpain from a procedure2.9%8,503
Headachehead pain2.8%8,191
Drug ineffectivethe medicine did not work as expected2.7%7,973
Device breakagethe device broke2.7%7,971
Uterine perforationa hole in the wall of the womb2.5%7,430
Menorrhagiaheavy periods2.5%7,308
Pelvic pain2.4%7,092
Amenorrhoeaperiods stopped2.4%6,936
Weight increasedweight gain2.1%6,271
Menstruation delayed2.1%6,215

Solid bar: share of all class reports. Hollow bar: the median share across the 17 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death0.4%1,311

Life-threatening0.9%2,706

Hospitalisation (initial or prolonged)5.2%15,371

Disability1.2%3,666

Congenital anomaly0.1%317

Other serious38.5%113,080

Not serious58.1%170,527

Patient age

Under 20.1%274

2 to 110%87

12 to 172.7%7,780

18 to 4445.1%132,267

45 to 646.5%19,203

65 to 740.7%2,115

75 and over0.2%457

Age not given44.7%131,309

Who reported

Physician20.1%58,914

Pharmacist2.5%7,397

Other health professional15.5%45,516

Lawyer9.8%28,797

Consumer or non-health professional46.4%136,208

Not given5.7%16,660

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Progestin reports

Which drugs are in the Progestin class on this site?

Mirena, Nexplanon, Plan B One-Step, Provera, Depo-Provera and Liletta and 11 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

293,492 reports through June 2026, 19,262 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

device expulsion (16.3%), device dislocation (7.9%), vaginal haemorrhage (6%), menstruation irregular (5.8%) and breast cancer female (4.5%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.