MedDRA preferred term · the medicine was taken at the wrong times

Inappropriate schedule of drug administration: adverse event reports recording this term

71,216 reports to FDA record it, 2005–2018; 0.3% 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.

71,216
reports recording the term: 0.3% of all reports; 0
reports, 12 months to June 2026: 0 in the 12 months before; 28.6%
marked serious by the reporter: 57.4% across all reports; 2.6%
record death among outcomes, as reported: 9.1% across all reports

71,216 reports in FDA's adverse event database record the MedDRA term "Inappropriate schedule of drug administration" (in plain words, the medicine was taken at the wrong times): 0.3% of all reports received between February 2005 and September 2018. Coders pick the term that best matches the reporter's description.

0 reports recorded it in the 12 months to June 2026, and none 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, 28.6% are marked serious, 2.6% include death among the outcomes and 12% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Enbrel 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	—	4,921	0.8%
Enbrel	Tumor necrosis factor blocker	2,335	0.4%
Cosentyx	Interleukin-17A antagonist	2,266	1.5%
Nuvaring	Estrogen	2,207	11.8%
Ampyra	Potassium channel blocker	1,663	3%
Ilaris	—	1,242	13.3%
Soliris	Complement inhibitor	1,232	2.3%
Xarelto	Factor Xa inhibitor	1,188	0.9%
Duragesic-100	—	1,145	11.7%
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	1,072	2.1%
Proactiv Solution Daily Protection Plus Sunscreen Spf 30	—	890	8.3%
Prolia	RANK ligand inhibitor	802	0.6%
Mens Rogaine Extra Strength	—	780	6.2%
MiraLAX	Osmotic laxative	767	2%
Invega Sustenna	Atypical antipsychotic	730	3.1%
Sandostatin LAR Depot	—	718	4.2%
Ortho Evra	—	637	4.3%
Restasis	Calcineurin inhibitor immunosuppressant	603	3.3%
Tylenol 8 HR Arthritis Pain	—	598	12.1%
Janumet	Biguanide	589	5.6%
TYLENOL Extra Strength	—	572	7.3%
Stelara	Interleukin-12 antagonist	566	0.7%
Entresto	Angiotensin 2 receptor blocker	565	0.5%
Repatha	PCSK9 inhibitor	555	0.4%
Saphris	Atypical antipsychotic	541	8.3%

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 0.3% 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	3,686	0.3%	0%
Estrogen	2,580	2%	0.1%
Atypical antipsychotic	2,383	0.3%	0.1%
Interleukin-17A antagonist	2,328	1.2%	0.2%
Nonsteroidal anti-inflammatory drug	1,883	0.3%	0.1%
Potassium channel blocker	1,663	2.6%	0%
Corticosteroid	1,361	0.2%	0%
Factor Xa inhibitor	1,339	0.4%	0%
Complement inhibitor	1,232	1.8%	0%
Proton pump inhibitor	1,062	0.2%	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 20.2%133

2 to 111%701

12 to 171.8%1,251

18 to 4414.7%10,462

45 to 6419.2%13,682

65 to 749.4%6,691

75 and over8.8%6,237

Age not given45%32,059

Patient sex

Female61%43,407

Male32%22,773

Not given7.1%5,036

Grey bar: all 20,646,523 reports in the database. 85.5% of these reports give the United States as the country.

Questions about "Inappropriate schedule of drug administration"

What does "Inappropriate schedule of drug administration" mean in an adverse event report?

In plain language: the medicine was taken at the wrong times. 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 inappropriate schedule of drug administration?

71,216 reports through June 2026 (0.3% of all reports), 0 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (4,921), Enbrel (2,335), Cosentyx (2,266), Nuvaring (2,207) and Ampyra (1,663). 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.