MedDRA preferred term · dependence on a medicine

Drug dependence: adverse event reports recording this term

159,875 reports to FDA record it, 2004–2026; 0.8% 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.

159,875
reports recording the term: 0.8% of all reports; 2,064
reports, 12 months to June 2026: 2,666 in the 12 months before; 97.8%
marked serious by the reporter: 57.4% across all reports; 10%
record death among outcomes, as reported: 9.1% across all reports

159,875 reports in FDA's adverse event database record the MedDRA term "Drug dependence" (in plain words, dependence on a medicine): 0.8% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

2,064 reports recorded it in the 12 months to June 2026, down 23% from 2,666 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, 97.8% are marked serious, 10% include death among the outcomes and 8.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are OxyContin, Oxycodone hydrochloride and Hydrocodone bitartrate and acetaminophen. 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	93,483	63.9%
Oxycodone hydrochloride	Opioid agonist	63,208	55.8%
Hydrocodone bitartrate and acetaminophen	Opioid agonist	34,961	59.2%
Dilaudid	Opioid agonist	33,707	52.5%
MS Contin	Opioid agonist	27,006	51.8%
Morphine sulfate	Opioid agonist	21,031	35%
Oxycodone and acetaminophen	Opioid agonist	19,010	76.3%
Tramadol	—	14,409	30.4%
Acetaminophen Oxycodone Hydrochloride	—	12,568	38.8%
Butrans	Partial opioid agonist	9,230	15.4%
Percocet	Opioid agonist	8,557	14.8%
Hydrocodone bitartrate	Opioid agonist	7,928	69.1%
Vicodin	—	6,678	56%
Hysingla ER	Opioid agonist	6,302	20.5%
Fentanyl	Opioid agonist	6,054	11.3%
Hydromorphone	—	5,548	15.3%
Acetaminophen Oxycodone Hydrochloride Oxycodone Terephthalate	—	5,284	89.3%
Methadone	Opioid agonist	5,056	20.8%
Oxycodone	Opioid agonist	4,814	13.5%
Buprenorphine Transdermal Patch	—	4,623	85.4%
Hydromorphone hydrochloride	Opioid agonist	4,454	37.7%
Buprenorphine	Partial opioid agonist	4,406	22.9%
Suboxone	Opioid antagonist	4,187	20%
Norco	Opioid agonist	4,044	16.4%
Hydromorphone Tablets	—	3,852	91.4%

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 0.8% 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	350,674	36.3%	5.6%
Partial opioid agonist	14,185	14.9%	2.8%
Benzodiazepine	8,521	3.5%	3.3%
Proton pump inhibitor	6,406	1.3%	0.3%
Opioid antagonist	4,749	15.2%	5.3%
Corticosteroid	2,249	0.3%	0.1%
Serotonin reuptake inhibitor	2,084	0.8%	0.5%
Nonsteroidal anti-inflammatory drug	2,070	0.4%	0.2%
Central nervous system stimulant	2,032	1.9%	1.1%
Atypical antipsychotic	2,012	0.3%	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 20.1%225

2 to 110.2%325

12 to 170.5%805

18 to 448.1%12,903

45 to 645.2%8,292

65 to 741.5%2,414

75 and over0.9%1,372

Age not given83.5%133,539

Patient sex

Female38.5%61,530

Male53.7%85,860

Not given7.8%12,485

Grey bar: all 20,646,523 reports in the database. 86.9% of these reports give the United States as the country.

Questions about "Drug dependence"

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

In plain language: dependence on a medicine. 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 dependence?

159,875 reports through June 2026 (0.8% of all reports), 2,064 of them in the latest 12 months.

Which drugs appear most often in these reports?

OxyContin (93,483), Oxycodone hydrochloride (63,208), Hydrocodone bitartrate and acetaminophen (34,961), Dilaudid (33,707) and MS Contin (27,006). 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.