MedDRA preferred term · the medicine did not work as expected

Drug ineffective: adverse event reports recording this term

1,296,884 reports to FDA record it, 2004–2026; 6.3% 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.

1,296,884
reports recording the term: 6.3% of all reports; 71,499
reports, 12 months to June 2026: 75,322 in the 12 months before; 35.2%
marked serious by the reporter: 57.4% across all reports; 3%
record death among outcomes, as reported: 9.1% across all reports

"Drug ineffective" (in plain words, the medicine did not work as expected) is a MedDRA preferred term recorded in 1,296,884 adverse event reports received by FDA, 6.3% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

71,499 reports recorded it in the 12 months to June 2026, close to the 75,322 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, 35.2% are marked serious, 3% include death among the outcomes and 10.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Enbrel and Methotrexate. 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	—	79,047	12.4%
Enbrel	Tumor necrosis factor blocker	68,980	12.3%
Methotrexate	Folate analog metabolic inhibitor	54,411	26.3%
Orencia	Selective T cell costimulation modulator	34,719	31.9%
Prednisone	Corticosteroid	30,289	16.5%
Actemra	Interleukin-6 receptor antagonist	29,876	37.3%
Xeljanz	Janus kinase inhibitor	29,597	19%
Dupixent	Interleukin-4 receptor alpha antagonist	28,677	6.2%
Remicade	Tumor necrosis factor blocker	28,095	18.1%
Cosentyx	Interleukin-17A antagonist	27,161	18%
Rituximab	CD20-directed cytolytic antibody	25,152	16.2%
Sulfasalazine	Aminosalicylate	22,397	55%
Cimzia	Tumor necrosis factor blocker	22,162	25.4%
BOTOX Cosmetic	Acetylcholine release inhibitor	20,347	52.5%
Methotrexate sodium	Folate analog metabolic inhibitor	18,764	27.8%
Leflunomide	Antirheumatic agent	18,437	49.8%
Arava	Antirheumatic agent	18,223	53.3%
Simponi	Tumor necrosis factor blocker	17,266	24.5%
Hydroxychloroquine	Antimalarial	15,882	39.2%
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	15,522	29.9%
Hydroxychloroquine sulfate	Antimalarial	15,110	62.9%
Lyrica	—	14,403	11.9%
Otezla	Phosphodiesterase 4 inhibitor	13,552	10%
Plaquenil	Antimalarial	11,890	55.2%
Stelara	Interleukin-12 antagonist	11,773	13.6%

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 6.3% 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	173,226	16.3%	15.4%
Corticosteroid	121,620	15%	13.4%
Nonsteroidal anti-inflammatory drug	81,011	14.8%	13.9%
Folate analog metabolic inhibitor	74,524	23.9%	8.5%
Atypical antipsychotic	46,255	6.8%	6.4%
Antimalarial	43,249	46.8%	9.3%
Interleukin-6 receptor antagonist	42,157	31.4%	23.8%
Janus kinase inhibitor	40,518	12.5%	9.3%
CD20-directed cytolytic antibody	39,361	12.5%	3.5%
Opioid agonist	38,061	3.9%	4%

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 20.4%4,991

2 to 111.3%16,899

12 to 171.7%22,074

18 to 4411.6%150,172

45 to 6418.3%236,863

65 to 748.5%110,102

75 and over5.9%76,785

Age not given52.4%678,998

Patient sex

Female53.8%697,242

Male31.1%403,144

Not given15.2%196,498

Grey bar: all 20,646,523 reports in the database. 78.7% of these reports give the United States as the country.

Questions about "Drug ineffective"

What does "Drug ineffective" mean in an adverse event report?

In plain language: the medicine did not work as expected. 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 drug ineffective?

1,296,884 reports through June 2026 (6.3% of all reports), 71,499 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (79,047), Enbrel (68,980), Methotrexate (54,411), Orencia (34,719) and Prednisone (30,289). 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.