MedDRA preferred term

Normal newborn: adverse event reports recording this term

5,281 reports to FDA record it, 2004–2026; 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.

5,281
reports recording the term: 0% of all reports; 291
reports, 12 months to June 2026: 308 in the 12 months before; 66.4%
marked serious by the reporter: 57.4% across all reports; 6.1%
record death among outcomes, as reported: 9.1% across all reports

"Normal newborn" is a MedDRA preferred term recorded in 5,281 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

291 reports recorded it in the 12 months to June 2026, close to the 308 of 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, 66.4% are marked serious, 6.1% include death among the outcomes and 21.6% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Prednisone and Cosentyx. 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
Humira	—	533	0.1%
Prednisone	Corticosteroid	362	0.2%
Cosentyx	Interleukin-17A antagonist	359	0.2%
Gilenya	Sphingosine 1-phosphate receptor modulator	337	0.4%
Rituximab	CD20-directed cytolytic antibody	264	0.2%
Erelzi	—	228	1.7%
Folic acid	Vitamin B12	226	0.9%
Acetaminophen	Nonsteroidal anti-inflammatory drug	225	0.3%
Methotrexate	Folate analog metabolic inhibitor	223	0.1%
Infliximab	Tumor necrosis factor blocker	216	0.4%
Leflunomide	Antirheumatic agent	216	0.6%
Tamiflu	Neuraminidase inhibitor	206	1.6%
Azathioprine	Purine antimetabolite	205	0.6%
Actemra	Interleukin-6 receptor antagonist	200	0.2%
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	198	0.4%
Adalimumab	Tumor necrosis factor blocker	190	0.5%
Sulfasalazine	Aminosalicylate	186	0.5%
Hydrocortisone	Corticosteroid	185	0.9%
Arava	Antirheumatic agent	177	0.5%
Desoximetasone	Corticosteroid	177	1.4%
Hydroxychloroquine	Antimalarial	176	0.4%
Enbrel	Tumor necrosis factor blocker	175	0%
Rebif	Interferon beta	169	0.4%
Simponi	Tumor necrosis factor blocker	164	0.2%
Tramadol hydrochloride	Opioid agonist	162	0.6%

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
Corticosteroid	1,680	0.2%	0%
Tumor necrosis factor blocker	1,357	0.1%	0.1%
Nonsteroidal anti-inflammatory drug	1,253	0.2%	0%
Opioid agonist	655	0.1%	0%
Histamine-1 receptor antagonist	404	0.3%	0%
Interleukin-6 receptor antagonist	395	0.3%	0.3%
Antirheumatic agent	393	0.6%	0.6%
Interleukin-17A antagonist	378	0.2%	0.1%
CD20-directed cytolytic antibody	372	0.1%	0%
Antimalarial	362	0.4%	0.1%

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 21.4%75

2 to 110%0

12 to 170.3%18

18 to 4457.8%3,054

45 to 640.3%17

65 to 740%0

75 and over0%0

Age not given40.1%2,117

Patient sex

Female84.4%4,457

Male6%318

Not given9.6%506

Grey bar: all 20,646,523 reports in the database. 35.2% of these reports give the United States as the country.

Questions about "Normal newborn"

What does "Normal newborn" 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 normal newborn?

5,281 reports through June 2026 (0% of all reports), 291 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (533), Prednisone (362), Cosentyx (359), Gilenya (337) and Rituximab (264). 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.