MedDRA preferred term

Autism spectrum disorder: adverse event reports recording this term

5,396 reports to FDA record it, 2005–2026; 0% 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.

5,396
reports recording the term: 0% of all reports; 1,469
reports, 12 months to June 2026: 403 in the 12 months before; 98.2%
marked serious by the reporter: 57.4% across all reports; 0.6%
record death among outcomes, as reported: 9.1% across all reports

5,396 reports in FDA's adverse event database record the MedDRA term "Autism spectrum disorder": 0% of all reports received between February 2005 and June 2026. Coders pick the term that best matches the reporter's description.

1,469 reports recorded it in the 12 months to June 2026, up 265% from 403 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, 98.2% are marked serious, 0.6% include death among the outcomes and 9.7% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Tylenol, TYLENOL Extra Strength and Tylenol Regular Strength. 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
Tylenol	Expectorant	1,099	3.6%
TYLENOL Extra Strength	—	610	7.8%
Tylenol Regular Strength	—	536	26.6%
Acetaminophen	Nonsteroidal anti-inflammatory drug	475	0.5%
Valproate sodium	Anti-epileptic agent	244	2.1%
Acetaminophen Hydrocodone Bitartrate	—	207	0.7%
Acetaminophen Oxycodone Hydrochloride	—	203	0.6%
Percocet	Opioid agonist	123	0.2%
Lamotrigine	Anti-epileptic agent	98	0.2%
Lisdexamfetamine dimesylate	Central nervous system stimulant	85	2%
Valproic acid	Anti-epileptic agent	77	0.4%
Tramadol hydrochloride	Opioid agonist	74	0.3%
Topiramate	—	70	0.3%
Depakine Chrono	—	65	3.8%
Risperidone	Atypical antipsychotic	63	0.1%
Morphine sulfate	Opioid agonist	62	0.1%
Aripiprazole	Atypical antipsychotic	61	0.2%
Epilim	—	60	3.2%
Paxil	Serotonin reuptake inhibitor	58	0.2%
Humira	—	57	0%
Levetiracetam	—	56	0.1%
Dupixent	Interleukin-4 receptor alpha antagonist	55	0%
Carbamazepine	Mood stabilizer	53	0.2%
Depakine	—	53	2.6%
Fluoxetine hydrochloride	Serotonin reuptake inhibitor	53	0.9%

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% 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
Expectorant	1,099	2.1%	0%
Opioid agonist	553	0.1%	0%
Anti-epileptic agent	532	0.2%	0%
Nonsteroidal anti-inflammatory drug	483	0.1%	0%
Atypical antipsychotic	369	0.1%	0%
Serotonin reuptake inhibitor	228	0.1%	0%
Central nervous system stimulant	201	0.2%	0%
Mood stabilizer	99	0.2%	0.2%
Benzodiazepine	68	0%	0%
Integrin receptor antagonist	68	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 23.4%185

2 to 1112.9%694

12 to 173.2%172

18 to 446.6%354

45 to 641.2%63

65 to 740.3%16

75 and over0.1%4

Age not given72.4%3,908

Patient sex

Female20.8%1,123

Male48.9%2,639

Not given30.3%1,634

Grey bar: all 20,646,523 reports in the database. 64% of these reports give the United States as the country.

Questions about "Autism spectrum disorder"

What does "Autism spectrum disorder" mean in an adverse event report?

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 autism spectrum disorder?

5,396 reports through June 2026 (0% of all reports), 1,469 of them in the latest 12 months.

Which drugs appear most often in these reports?

Tylenol (1,099), TYLENOL Extra Strength (610), Tylenol Regular Strength (536), Acetaminophen (475) and Valproate sodium (244). 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.