MedDRA preferred term · a dose above the recommended amount

Overdose: adverse event reports recording this term

213,059 reports to FDA record it, 2004–2026; 1% 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.

213,059
reports recording the term: 1% of all reports; 7,825
reports, 12 months to June 2026: 7,032 in the 12 months before; 79.1%
marked serious by the reporter: 57.4% across all reports; 19%
record death among outcomes, as reported: 9.1% across all reports

"Overdose" (in plain words, a dose above the recommended amount) is a MedDRA preferred term recorded in 213,059 adverse event reports received by FDA, 1% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

7,825 reports recorded it in the 12 months to June 2026, up 11% from 7,032 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, 79.1% are marked serious, 19% include death among the outcomes and 27.8% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are OxyContin, Oxycodone hydrochloride and Dilaudid. 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
OxyContin	Opioid agonist	45,368	31%
Oxycodone hydrochloride	Opioid agonist	33,455	29.5%
Dilaudid	Opioid agonist	21,956	34.2%
Hydrocodone bitartrate and acetaminophen	Opioid agonist	18,068	30.6%
MS Contin	Opioid agonist	17,997	34.5%
Percocet	Opioid agonist	15,551	26.9%
Morphine sulfate	Opioid agonist	12,587	20.9%
Acetaminophen Oxycodone Hydrochloride	—	11,040	34%
Butrans	Partial opioid agonist	9,196	15.3%
Oxycodone and acetaminophen	Opioid agonist	8,721	35%
Opana	—	8,702	27.8%
Acetaminophen Hydrocodone Bitartrate	—	8,482	29.3%
Hysingla ER	Opioid agonist	7,998	26%
Hydromorphone	—	7,755	21.4%
Opana Er	—	7,732	25.2%
Tramadol	—	7,217	15.2%
Acetaminophen	Nonsteroidal anti-inflammatory drug	7,008	8.1%
Percodan	—	6,112	25.1%
Duragesic	—	5,922	19.2%
Nucynta	Opioid agonist	5,801	21%
Fentanyl	Opioid agonist	5,525	10.3%
Actiq	—	5,513	22.3%
Fentora	—	5,446	22.4%
Oxymorphone hcl	—	4,709	27.6%
Norco	Opioid agonist	4,693	19%

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 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

Class	Reports with this term	Share of class reports	Median drug in class
Opioid agonist	232,032	24%	13.6%
Nonsteroidal anti-inflammatory drug	15,037	2.7%	0.8%
Atypical antipsychotic	13,830	2%	1.1%
Partial opioid agonist	13,401	14.1%	7.2%
Benzodiazepine	12,886	5.3%	5%
Serotonin reuptake inhibitor	7,761	2.8%	2.9%
Corticosteroid	6,870	0.8%	0.4%
Tumor necrosis factor blocker	6,797	0.6%	0.5%
Anti-epileptic agent	6,039	2.2%	1.5%
Histamine-1 receptor antagonist	5,848	4.3%	1.9%

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 20.6%1,366

2 to 111.8%3,773

12 to 174.4%9,329

18 to 4417.3%36,755

45 to 6412.4%26,388

65 to 744.8%10,220

75 and over4.8%10,194

Age not given54%115,034

Patient sex

Female43.4%92,474

Male40.8%86,952

Not given15.8%33,633

Grey bar: all 20,646,523 reports in the database. 72.1% of these reports give the United States as the country.

Questions about "Overdose"

What does "Overdose" mean in an adverse event report?

In plain language: a dose above the recommended amount. 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 overdose?

213,059 reports through June 2026 (1% of all reports), 7,825 of them in the latest 12 months.

Which drugs appear most often in these reports?

OxyContin (45,368), Oxycodone hydrochloride (33,455), Dilaudid (21,956), Hydrocodone bitartrate and acetaminophen (18,068) and MS Contin (17,997). 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.