MedDRA preferred term · movement problems such as stiffness or tremor

Extrapyramidal disorder: adverse event reports recording this term

24,716 reports to FDA record it, 2004–2026; 0.1% 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.

24,716
reports recording the term: 0.1% of all reports; 557
reports, 12 months to June 2026: 570 in the 12 months before; 89.7%
marked serious by the reporter: 57.4% across all reports; 3%
record death among outcomes, as reported: 9.1% across all reports

24,716 reports in FDA's adverse event database record the MedDRA term "Extrapyramidal disorder" (in plain words, movement problems such as stiffness or tremor): 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

557 reports recorded it in the 12 months to June 2026, close to the 570 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, 89.7% are marked serious, 3% include death among the outcomes and 31.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Metoclopramide, Reglan and Risperidone. 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
Metoclopramide	Dopamine-2 receptor antagonist	11,631	52.1%
Reglan	Dopamine-2 receptor antagonist	3,249	39.9%
Risperidone	Atypical antipsychotic	1,969	4.4%
Risperdal	Atypical antipsychotic	1,615	3%
Olanzapine	Atypical antipsychotic	1,287	2.7%
Metoclopramide hydrochloride	Dopamine-2 receptor antagonist	1,166	25.6%
Haloperidol	Typical antipsychotic	1,132	7.9%
Aripiprazole	Atypical antipsychotic	996	3.3%
Abilify	Atypical antipsychotic	849	1.6%
Quetiapine	Atypical antipsychotic	737	1.4%
Clozapine	Atypical antipsychotic	444	0.6%
Invega	Atypical antipsychotic	408	2.4%
Haldol	—	372	4.2%
Invega Sustenna	Atypical antipsychotic	367	1.6%
Seroquel	Atypical antipsychotic	310	0.6%
Zyprexa	Atypical antipsychotic	276	1%
Lorazepam	Benzodiazepine	273	0.8%
Lithium	Mood stabilizer	256	2.4%
Sertraline	Serotonin reuptake inhibitor	249	0.6%
Amisulpride	Dopamine-2 receptor antagonist	243	6.9%
Risperdal Consta	—	231	1.7%
Quetiapine fumarate	Atypical antipsychotic	225	1.1%
Mirtazapine	—	217	0.7%
Geodon	Atypical antipsychotic	216	2.5%
Valproic acid	Anti-epileptic agent	205	1%

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 0.1% 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
Dopamine-2 receptor antagonist	16,303	40.7%	16.3%
Atypical antipsychotic	11,047	1.6%	1.6%
Typical antipsychotic	1,295	7.9%	7.9%
Serotonin reuptake inhibitor	1,267	0.5%	0.4%
Anti-epileptic agent	927	0.3%	0%
Benzodiazepine	852	0.3%	0.2%
Mood stabilizer	484	0.8%	1%
Serotonin and norepinephrine reuptake inhibitor	457	0.3%	0.1%
Phenothiazine	283	1.8%	0.7%
Nonsteroidal anti-inflammatory drug	232	0%	0%

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 20.3%68

2 to 112%487

12 to 172.9%709

18 to 4411.9%2,947

45 to 649.1%2,241

65 to 744.2%1,026

75 and over4.3%1,075

Age not given65.4%16,163

Patient sex

Female53.2%13,159

Male37.6%9,292

Not given9.2%2,265

Grey bar: all 20,646,523 reports in the database. 67.5% of these reports give the United States as the country.

Questions about "Extrapyramidal disorder"

What does "Extrapyramidal disorder" mean in an adverse event report?

In plain language: movement problems such as stiffness or tremor. 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 extrapyramidal disorder?

24,716 reports through June 2026 (0.1% of all reports), 557 of them in the latest 12 months.

Which drugs appear most often in these reports?

Metoclopramide (11,631), Reglan (3,249), Risperidone (1,969), Risperdal (1,615) and Olanzapine (1,287). 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.