MedDRA preferred term

Maternal exposure before pregnancy: adverse event reports recording this term

6,705 reports to FDA record it, 2008–2026; 0% of the database.

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.

6,705
reports recording the term: 0% of all reports; 524
reports, 12 months to June 2026: 688 in the 12 months before; 79.5%
marked serious by the reporter: 57.4% across all reports; 1.7%
record death among outcomes, as reported: 9.1% across all reports

6,705 reports in FDA's adverse event database record the MedDRA term "Maternal exposure before pregnancy": 0% of all reports received between February 2008 and June 2026. Coders pick the term that best matches the reporter's description.

524 reports recorded it in the 12 months to June 2026, down 24% from 688 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 79.5% are marked serious, 1.7% include death among the outcomes and 16.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Certolizumab pegol, Cimzia and Nuvaring. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

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

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Certolizumab pegol	Tumor necrosis factor blocker	900	3.3%
Cimzia	Tumor necrosis factor blocker	830	1%
Nuvaring	Estrogen	424	2.3%
Ocrevus	CD20-directed cytolytic antibody	395	0.8%
Plan B One-Step	Progestin	383	1.1%
Methotrexate	Folate analog metabolic inhibitor	244	0.1%
Levetiracetam	—	172	0.3%
Gilenya	Sphingosine 1-phosphate receptor modulator	171	0.2%
Cyclophosphamide	Alkylating drug	134	0.1%
Prednisone	Corticosteroid	127	0.1%
Rituximab	CD20-directed cytolytic antibody	122	0.1%
Keppra	—	105	0.4%
Remicade	Tumor necrosis factor blocker	105	0.1%
Lacosamide	—	99	0.7%
Xolair	Anti-IgE	97	0.1%
Etoposide	Topoisomerase inhibitor	94	0.2%
Mirena	Progestin	94	0.1%
Vincristine	—	94	0.2%
Ocrelizumab	CD20-directed cytolytic antibody	90	1.3%
Folic acid	Vitamin B12	84	0.3%
Actinomycin D	—	83	6.7%
Mavenclad	Purine antimetabolite	78	1.2%
Vimpat	—	77	0.7%
Sulfasalazine	Aminosalicylate	71	0.2%
Simponi	Tumor necrosis factor blocker	61	0.1%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0% across the whole database. 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."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Tumor necrosis factor blocker	2,051	0.2%	0.1%
CD20-directed cytolytic antibody	626	0.2%	0%
Progestin	603	0.2%	0%
Estrogen	427	0.3%	0%
Corticosteroid	346	0%	0%
Folate analog metabolic inhibitor	282	0.1%	0%
Nonsteroidal anti-inflammatory drug	198	0%	0%
Sphingosine 1-phosphate receptor modulator	181	0.2%	0%
Alkylating drug	161	0.1%	0%
Histamine-1 receptor antagonist	157	0.1%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 24.5%300

2 to 110.2%14

12 to 170.6%39

18 to 4445.6%3,058

45 to 640.4%29

65 to 740%2

75 and over0%0

Age not given48.7%3,263

Patient sex

Female85.9%5,758

Male3.8%255

Not given10.3%692

Grey bar: all 20,646,523 reports in the database. 47.8% of these reports give the United States as the country.

Questions about "Maternal exposure before pregnancy"

What does "Maternal exposure before pregnancy" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record maternal exposure before pregnancy?

6,705 reports through June 2026 (0% of all reports), 524 of them in the latest 12 months.

Which drugs appear most often in these reports?

Certolizumab pegol (900), Cimzia (830), Nuvaring (424), Ocrevus (395) and Plan B One-Step (383). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.