Reported Reactions

Reactions

MedDRA preferred term

Labelled drug-drug interaction medication error: adverse event reports recording this term

8,807 reports to FDA record it, 2004–2026; 0% of the database.

8,807
reports recording the term
0% of all reports
213
reports, 12 months to June 2026
224 in the 12 months before
83.4%
marked serious by the reporter
57.4% across all reports
8.7%
record death among outcomes, as reported
9.1% across all reports

"Labelled drug-drug interaction medication error" is a MedDRA preferred term recorded in 8,807 adverse event reports received by FDA, 0% of the database, from June 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

213 reports recorded it in the 12 months to June 2026, close to the 224 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, 83.4% are marked serious, 8.7% include death among the outcomes and 47.6% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Clopidogrel, Aspirin and Acetylsalicylic Acid. 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

082164Jul 2021: 66Aug 2021: 55Sep 2021: 62Oct 2021: 48Nov 2021: 40Dec 2021: 1522022Jan 2022: 66Feb 2022: 49Mar 2022: 75Apr 2022: 33May 2022: 51Jun 2022: 34Jul 2022: 30Aug 2022: 28Sep 2022: 162Oct 2022: 164Nov 2022: 80Dec 2022: 562023Jan 2023: 51Feb 2023: 33Mar 2023: 40Apr 2023: 42May 2023: 36Jun 2023: 49Jul 2023: 24Aug 2023: 25Sep 2023: 28Oct 2023: 25Nov 2023: 20Dec 2023: 482024Jan 2024: 22Feb 2024: 17Mar 2024: 11Apr 2024: 18May 2024: 18Jun 2024: 14Jul 2024: 18Aug 2024: 20Sep 2024: 31Oct 2024: 14Nov 2024: 17Dec 2024: 462025Jan 2025: 10Feb 2025: 19Mar 2025: 9Apr 2025: 18May 2025: 11Jun 2025: 11Jul 2025: 12Aug 2025: 26Sep 2025: 8Oct 2025: 15Nov 2025: 20Dec 2025: 592026Jan 2026: 8Feb 2026: 18Mar 2026: 7Apr 2026: 11May 2026: 19Jun 2026: 10

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
ClopidogrelP2Y12 platelet inhibitor1,0403.5%
AspirinNonsteroidal anti-inflammatory drug1,0011.4%
Acetylsalicylic Acid—1,0004%
WarfarinVitamin K antagonist5672.4%
ClarithromycinMacrolide antimicrobial3671.7%
Heparin—2892%
ApixabanFactor Xa inhibitor2760.6%
XareltoFactor Xa inhibitor2650.2%
EliquisFactor Xa inhibitor2640.2%
TacrolimusCalcineurin inhibitor immunosuppressant2590.3%
SimvastatinHMG-CoA reductase inhibitor2580.7%
RivaroxabanFactor Xa inhibitor2511.5%
ExparelAmide local anesthetic24011.1%
Warfarin sodiumVitamin K antagonist2091.1%
TorsemideLoop diuretic2073.9%
Metoprololbeta-Adrenergic blocker1980.7%
Anoro ElliptaAnticholinergic1971.6%
IbuprofenNonsteroidal anti-inflammatory drug1920.2%
AllopurinolXanthine oxidase inhibitor1850.8%
RamiprilAngiotensin converting enzyme inhibitor1840.5%
Atorvastatin—1750.4%
Breo ElliptaCorticosteroid1720.8%
PlavixP2Y12 platelet inhibitor1680.5%
OmeprazoleProton pump inhibitor1570.3%
SpironolactoneAldosterone antagonist1550.7%

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

ClassReports with this termShare of class reportsMedian drug in class
Nonsteroidal anti-inflammatory drug1,7850.3%0%
P2Y12 platelet inhibitor1,4621.5%0.7%
Factor Xa inhibitor1,0670.3%0.2%
Vitamin K antagonist7761.8%1.8%
Corticosteroid6180.1%0%
Anticholinergic4860.3%0%
Serotonin reuptake inhibitor4230.2%0.1%
beta-Adrenergic blocker4150.3%0%
Proton pump inhibitor4080.1%0%
Amide local anesthetic4041%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 20.2%19
2 to 110.7%59
12 to 170.9%75
18 to 448%707
45 to 6420.8%1,836
65 to 7418.5%1,627
75 and over25.5%2,243
Age not given25.4%2,241

Patient sex

Female42.5%3,745
Male43.5%3,827
Not given14%1,235

Grey bar: all 20,646,523 reports in the database. 39% of these reports give the United States as the country.

Questions about "Labelled drug-drug interaction medication error"

What does "Labelled drug-drug interaction medication error" 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 labelled drug-drug interaction medication error?

8,807 reports through June 2026 (0% of all reports), 213 of them in the latest 12 months.

Which drugs appear most often in these reports?

Clopidogrel (1,040), Aspirin (1,001), Acetylsalicylic Acid (1,000), Warfarin (567) and Clarithromycin (367). 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.