Autism spectrum disorder adverse event reports that record this term

Kind of term: MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From February 2005 to June 2026, FDA received 5,396 adverse event reports that record the MedDRA preferred term Autism spectrum disorder. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,469 reports in the 12 months to June 2026 and 403 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 459 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 1,469 (0.1%) record this term. Reports for female patients were 20.8% of the reports that record this term and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 112 drug pages with 10 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Autism spectrum disorder name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	43
Abilify Maintena		12
Acetaminophen		475
Acetaminophen Hydrocodone Bitartrate		207
Acetaminophen Oxycodone Hydrochloride		203
Actonel	Bisphosphonate	11
Amitriptyline hydrochloride	Tricyclic antidepressant	12
Aripiprazole	Atypical antipsychotic	61
Avonex	Interferon beta	10
Azithromycin Anhydrous		10
Buprenorphine Transdermal Patch		11
Butrans	Partial opioid agonist	10
Carbamazepine	Mood stabilizer	53
Cholecalciferol		10
Clobazam	Benzodiazepine	17
Clonazepam	Benzodiazepine	16
Clozapine	Atypical antipsychotic	38
Clozaril	Atypical antipsychotic	30
Concerta	Central nervous system stimulant	15
Cosentyx	Interleukin-17A antagonist	16
Cytotec	Prostaglandin E1 analog	13
Depakine		53
Depakine Chrono		65
Depakote	Anti-epileptic agent	37
Diazepam	Benzodiazepine	11
Dilaudid	Opioid agonist	23
Dupixent	Interleukin-4 receptor alpha antagonist	55
Endocet	Opioid agonist	13
Epilim		60
Escitalopram	Serotonin reuptake inhibitor	13
Fentanyl citrate	Opioid agonist	35
Fintepla		10
Fluoxetine	Serotonin reuptake inhibitor	35
Fluoxetine hydrochloride	Serotonin reuptake inhibitor	53
Folic acid		34
Genotropin		12
Human immunoglobulin g	Human immunoglobulin G	23
Humira		57
Hydrocodone bitartrate and acetaminophen	Opioid agonist	25
Hydrocortisone	Corticosteroid	11
Hydroxyzine	Antihistamine	11
Intuniv	Central alpha-2 adrenergic agonist	11
Keppra		24
Lamictal	Anti-epileptic agent	22
Lamotrigine	Anti-epileptic agent	98
Lamprene	Antimycobacterial	11
Latuda	Atypical antipsychotic	30
Levetiracetam		56
Lisdexamfetamine dimesylate	Central nervous system stimulant	85
Lorazepam	Benzodiazepine	15
Lyrica		10
Methylphenidate	Central nervous system stimulant	21
Methylphenidate hydrochloride	Central nervous system stimulant	19
MiraLAX	Osmotic laxative	23
Montelukast	Leukotriene receptor antagonist	24
Morphine sulfate	Opioid agonist	62
MS Contin	Opioid agonist	18
Olanzapine	Atypical antipsychotic	19
Omnitrope	Recombinant human growth hormone	32
Ondansetron	Serotonin-3 receptor antagonist	10
Opana		22
Opana Er		13
Oxcarbazepine	Anti-epileptic agent	10
Oxycodone and acetaminophen	Opioid agonist	24
Oxycodone hydrochloride	Opioid agonist	45
OxyContin	Opioid agonist	40
Oxymorphone hydrochloride	Opioid agonist	24
Paxil	Serotonin reuptake inhibitor	58
Percocet	Opioid agonist	123
Phenobarbital		13
Plaquenil	Antimalarial	10
Potassium chloride	Osmotic laxative	11
Prednisolone	Corticosteroid	11
Prednisone	Corticosteroid	21
Prozac	Serotonin reuptake inhibitor	10
Quetiapine	Atypical antipsychotic	33
Rifampin	Rifamycin antibacterial	11
Risperdal	Atypical antipsychotic	17
Risperidone	Atypical antipsychotic	63
Ritalin	Central nervous system stimulant	19
Ritalina		14
Saizen		12
Sertraline	Serotonin reuptake inhibitor	34
Singulair	Leukotriene receptor antagonist	25
Sodium valproate		29
Somatropin	Recombinant human growth hormone	11
Spinraza	Antisense oligonucleotide	11
Spravato		10
Tecfidera		11
Tegretol	Mood stabilizer	37
Topiramate		70
Tramadol		18
Tramadol hydrochloride	Opioid agonist	74
Trikafta		11
Trileptal	Anti-epileptic agent	15
Tylenol	Expectorant	1,099
TYLENOL Extra Strength		610
Tylenol Pm	Histamine-1 receptor antagonist	35
Tylenol Pm Extra Strength	Histamine-1 receptor antagonist	13
Tylenol Regular Strength		536
Tysabri	Integrin receptor antagonist	22
Urbanyl		21
Valproate sodium	Anti-epileptic agent	244
Valproic acid	Anti-epileptic agent	77
Vedolizumab	Integrin receptor antagonist	46
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	36
Vyvanse	Central nervous system stimulant	27
Xeljanz	Janus kinase inhibitor	11
Xolair	Anti-IgE	15
Xyrem	Central nervous system depressant	20
Xywav	Central nervous system depressant	15
Zofran		21

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 60 pharmacologic classes with 5 or more reports that record this term. The rows are in order of name.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Autism spectrum disorder name, in order of name
Class	Reports with this term
Aminoglycoside antibacterial	6
Aminoketone	6
Angiotensin 2 receptor blocker	6
Anti-epileptic agent	532
Anti-IgE	25
Antihistamine	11
Antimalarial	10
Antimetabolite immunosuppressant	9
Antimycobacterial	11
Antisense oligonucleotide	11
Atypical antipsychotic	369
Benzodiazepine	68
Biguanide	5
Bisphosphonate	11
Calcineurin inhibitor immunosuppressant	14
Carbonic anhydrase inhibitor	5
Central alpha-2 adrenergic agonist	18
Central nervous system depressant	35
Central nervous system stimulant	201
Corticosteroid	47
Cytochrome P450 3A inhibitor	8
Expectorant	1,099
Factor Xa inhibitor	5
Folate analog metabolic inhibitor	6
gamma-Aminobutyric acid A receptor positive modulator	5
GLP-1 receptor agonist	7
GLP-2 analog	6
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	9
Histamine-1 receptor antagonist	35
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	19
Human immunoglobulin G	25
Hydrolytic lysosomal glycosaminoglycan-specific enzyme	8
Insulin analog	23
Integrin receptor antagonist	68
Interferon beta	12
Interleukin-12 antagonist	7
Interleukin-17A antagonist	16
Interleukin-23 antagonist	6
Interleukin-4 receptor alpha antagonist	55
Janus kinase inhibitor	13
Leukotriene receptor antagonist	57
Mood stabilizer	99
Nonsteroidal anti-inflammatory drug	8
Norepinephrine reuptake inhibitor	6
Opioid agonist	553
Osmotic laxative	34
Partial opioid agonist	24
Phenothiazine	9
Prostaglandin E1 analog	13
Proton pump inhibitor	15
Purine antimetabolite	5
Recombinant human growth hormone	45
Rifamycin antibacterial	11
Serotonin and norepinephrine reuptake inhibitor	43
Serotonin reuptake inhibitor	228
Serotonin-3 receptor antagonist	10
Sigma-1 agonist	9
Tricyclic antidepressant	15
Tumor necrosis factor blocker	26
Vesicular monoamine transporter 2 inhibitor	5

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Autism spectrum disorder, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Autism spectrum disorder
Age	Reports	Share
Under 2	185	3.4%
2 to 11	694	12.9%
12 to 17	172	3.2%
18 to 44	354	6.6%
45 to 64	63	1.2%
65 to 74	16	0.3%
75 and over	4	0.1%
Age not given	3,908	72.4%

Sex of the patient in the reports that record Autism spectrum disorder
Sex	Reports	Share
Female	1,123	20.8%
Male	2,639	48.9%
Unknown or not given	1,634	30.3%

Age and sex are as the report gives them. 64% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Autism spectrum disorder: adverse event reports that record this term. https://reportedreactions.com/reaction/autism-spectrum-disorder/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

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

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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