Reported Reactions

Reactions

MedDRA preferred term

Malnutrition: adverse event reports recording this term

10,926 reports to FDA record it, 2004–2026; 0.1% of the database.

10,926
reports recording the term
0.1% of all reports
865
reports, 12 months to June 2026
739 in the 12 months before
96.3%
marked serious by the reporter
57.4% across all reports
25.7%
record death among outcomes, as reported
9.1% across all reports

10,926 reports in FDA's adverse event database record the MedDRA term "Malnutrition": 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

865 reports recorded it in the 12 months to June 2026, up 17% from 739 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, 96.3% are marked serious, 25.7% include death among the outcomes and 71.3% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Ozempic and Prednisone. 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

055110Jul 2021: 57Aug 2021: 61Sep 2021: 53Oct 2021: 47Nov 2021: 55Dec 2021: 562022Jan 2022: 42Feb 2022: 56Mar 2022: 54Apr 2022: 50May 2022: 75Jun 2022: 55Jul 2022: 49Aug 2022: 58Sep 2022: 53Oct 2022: 66Nov 2022: 42Dec 2022: 402023Jan 2023: 45Feb 2023: 36Mar 2023: 70Apr 2023: 50May 2023: 55Jun 2023: 52Jul 2023: 65Aug 2023: 53Sep 2023: 54Oct 2023: 50Nov 2023: 58Dec 2023: 432024Jan 2024: 49Feb 2024: 53Mar 2024: 61Apr 2024: 60May 2024: 44Jun 2024: 49Jul 2024: 65Aug 2024: 82Sep 2024: 63Oct 2024: 71Nov 2024: 58Dec 2024: 622025Jan 2025: 60Feb 2025: 64Mar 2025: 50Apr 2025: 62May 2025: 58Jun 2025: 44Jul 2025: 110Aug 2025: 75Sep 2025: 83Oct 2025: 64Nov 2025: 55Dec 2025: 902026Jan 2026: 60Feb 2026: 66Mar 2026: 75Apr 2026: 75May 2026: 53Jun 2026: 59

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

Drugs listed as suspect products in these reports

DrugClassReports with this termShare of the drug's own reports
Humira—6240.1%
OzempicGLP-1 receptor agonist2270.4%
PrednisoneCorticosteroid2230.1%
CyclophosphamideAlkylating drug2060.1%
CisplatinPlatinum-based drug2000.3%
RemicadeTumor necrosis factor blocker1750.1%
MethotrexateFolate analog metabolic inhibitor1710.1%
LantusInsulin analog1600.4%
DexamethasoneCorticosteroid1580.1%
RevlimidThalidomide analog1470%
CarboplatinPlatinum-based drug1460.1%
Vincristine—1390.2%
ValsartanAngiotensin 2 receptor blocker1370.8%
Creon—1360.7%
HumalogInsulin analog1330.2%
LosartanAngiotensin 2 receptor blocker1310.9%
RituximabCD20-directed cytolytic antibody1290.1%
TacrolimusCalcineurin inhibitor immunosuppressant1280.1%
LipitorHMG-CoA reductase inhibitor1270.2%
MounjaroGLP-1 receptor agonist1220.1%
FosamaxBisphosphonate1210.3%
VedolizumabIntegrin receptor antagonist1200.2%
PrednisoloneCorticosteroid1180.1%
EtoposideTopoisomerase inhibitor1140.2%
Mycophenolate mofetilAntimetabolite immunosuppressant1090.1%

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 0.1% 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

ClassReports with this termShare of class reportsMedian drug in class
Corticosteroid8040.1%0%
GLP-1 receptor agonist5930.1%0.1%
Kinase inhibitor5450.1%0%
Tumor necrosis factor blocker4760%0%
Nucleoside metabolic inhibitor4470.1%0.1%
Platinum-based drug4430.2%0.2%
Angiotensin 2 receptor blocker3670.2%0%
Opioid agonist3410%0%
Insulin analog3290.1%0%
HMG-CoA reductase inhibitor3230.2%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 21.1%118
2 to 112.2%237
12 to 172.3%252
18 to 4412.1%1,323
45 to 6422.4%2,443
65 to 7415.1%1,648
75 and over13.9%1,522
Age not given31%3,383

Patient sex

Female53.8%5,874
Male39%4,265
Not given7.2%787

Grey bar: all 20,646,523 reports in the database. 49.8% of these reports give the United States as the country.

Questions about "Malnutrition"

What does "Malnutrition" 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 malnutrition?

10,926 reports through June 2026 (0.1% of all reports), 865 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (624), Ozempic (227), Prednisone (223), Cyclophosphamide (206) and Cisplatin (200). 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.