MedDRA preferred term · symptoms on stopping a medicine

Drug withdrawal syndrome: adverse event reports recording this term

85,721 reports to FDA record it, 2004–2026; 0.4% 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.

85,721
reports recording the term: 0.4% of all reports; 1,163
reports, 12 months to June 2026: 944 in the 12 months before; 80.2%
marked serious by the reporter: 57.4% across all reports; 3.1%
record death among outcomes, as reported: 9.1% across all reports

85,721 reports in FDA's adverse event database record the MedDRA term "Drug withdrawal syndrome" (in plain words, symptoms on stopping a medicine): 0.4% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

1,163 reports recorded it in the 12 months to June 2026, up 23% from 944 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, 80.2% are marked serious, 3.1% include death among the outcomes and 13.9% 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	35,134	24%
Oxycodone hydrochloride	Opioid agonist	15,071	13.3%
Dilaudid	Opioid agonist	13,913	21.7%
MS Contin	Opioid agonist	12,012	23%
Cymbalta	Serotonin and norepinephrine reuptake inhibitor	7,331	14%
Hydrocodone bitartrate and acetaminophen	Opioid agonist	5,521	9.3%
Morphine sulfate	Opioid agonist	4,785	8%
Butrans	Partial opioid agonist	4,569	7.6%
Paxil	Serotonin reuptake inhibitor	3,976	16.4%
Hydrocodone bitartrate	Opioid agonist	3,911	34.1%
Suboxone	Opioid antagonist	3,351	16%
Hysingla ER	Opioid agonist	3,153	10.3%
Acetaminophen Oxycodone Hydrochloride Oxycodone Terephthalate	—	2,985	50.5%
Fentanyl	Opioid agonist	2,778	5.2%
Vicodin	—	2,273	19%
Acetaminophen Oxycodone Hydrochloride	—	2,257	7%
Percocet	Opioid agonist	2,255	3.9%
Tramadol	—	2,005	4.2%
Methadone	Opioid agonist	1,998	8.2%
Effexor	Serotonin and norepinephrine reuptake inhibitor	1,861	14.2%
Lyrica	—	1,772	1.5%
Oxycodone and acetaminophen	Opioid agonist	1,619	6.5%
Baclofen	gamma-Aminobutyric acid-ergic agonist	1,422	6.6%
Oxycodone	Opioid agonist	1,419	4%
Buprenorphine	Partial opioid agonist	1,356	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 0.4% 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	108,533	11.2%	2.5%
Serotonin and norepinephrine reuptake inhibitor	12,230	7.1%	2.6%
Serotonin reuptake inhibitor	7,441	2.7%	0.8%
Partial opioid agonist	7,363	7.8%	5.2%
Opioid antagonist	4,159	13.3%	8.1%
Benzodiazepine	3,636	1.5%	0.6%
gamma-Aminobutyric acid-ergic agonist	3,039	8.5%	8.8%
Atypical antipsychotic	2,391	0.3%	0.1%
Anti-epileptic agent	1,004	0.4%	0.1%
Central alpha-2 adrenergic agonist	589	1.9%	1.3%

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%166

2 to 110.3%300

12 to 170.7%625

18 to 4412.8%11,011

45 to 6411.9%10,161

65 to 742.5%2,123

75 and over1.2%1,051

Age not given70.3%60,284

Patient sex

Female48.3%41,377

Male46%39,450

Not given5.7%4,894

Grey bar: all 20,646,523 reports in the database. 84.8% of these reports give the United States as the country.

Questions about "Drug withdrawal syndrome"

What does "Drug withdrawal syndrome" mean in an adverse event report?

In plain language: symptoms on stopping 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 withdrawal syndrome?

85,721 reports through June 2026 (0.4% of all reports), 1,163 of them in the latest 12 months.

Which drugs appear most often in these reports?

OxyContin (35,134), Oxycodone hydrochloride (15,071), Dilaudid (13,913), MS Contin (12,012) and Cymbalta (7,331). 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.