Refusal of treatment by patient 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 January 2004 to June 2026, FDA received 6,425 adverse event reports that record the MedDRA preferred term Refusal of treatment by patient. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 262 reports in the 12 months to June 2026 and 309 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 1,271 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, 262 (under 0.1%) record this term. Reports for male patients were 41.2% of the reports that record this term and 34.6% 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 132 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 Refusal of treatment by patient name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	81
Abilify Maintena		132
Acetaminophen		16
Actos	Peroxisome proliferator receptor alpha agonist	17
Alprazolam	Benzodiazepine	10
Ambrisentan	Endothelin receptor antagonist	15
Aranesp	Erythropoiesis-stimulating agent	11
Aripiprazole	Atypical antipsychotic	85
Aspirin	Nonsteroidal anti-inflammatory drug	26
Atracurium		10
Avastin	Vascular endothelial growth factor inhibitor	14
Avonex	Interferon beta	19
Baclofen	gamma-Aminobutyric acid-ergic agonist	13
Bevacizumab	Vascular endothelial growth factor inhibitor	23
Capecitabine	Nucleoside metabolic inhibitor	16
Carbidopa levodopa	Aromatic amino acid	14
Carboplatin	Platinum-based drug	42
Celebrex	Nonsteroidal anti-inflammatory drug	13
Cetirizine	Histamine-1 receptor antagonist	10
Chlorphenamine		11
Cisplatin	Platinum-based drug	61
Citalopram hydrobromide	Serotonin reuptake inhibitor	12
Clexane		14
Clozapine	Atypical antipsychotic	100
Clozaril	Atypical antipsychotic	86
Coumadin		10
Cyclophosphamide	Alkylating drug	47
Cymbalta		13
Cytarabine	Nucleoside metabolic inhibitor	28
Daybue		119
Device		15
Dexamethasone	Corticosteroid	35
Dianeal		131
Dianeal Low Calcium		13
Diazepam	Benzodiazepine	17
Digoxin	Cardiac glycoside	74
Docetaxel	Microtubule inhibitor	10
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	23
Eligard	Gonadotropin releasing hormone receptor agonist	10
Eloxatin		10
Enbrel	Tumor necrosis factor blocker	48
Erbitux	Epidermal growth factor receptor antagonist	11
Etoposide	Topoisomerase inhibitor	17
Extraneal	Osmotic laxative	16
Eylea	Vascular endothelial growth factor inhibitor	150
Fentanyl	Opioid agonist	16
Fluorouracil	Nucleoside metabolic inhibitor	34
Forteo	Parathyroid hormone analog	24
Gemcitabine	Nucleoside metabolic inhibitor	10
Haldol		23
Haloperidol	Typical antipsychotic	38
Heparin sodium	Anti-coagulant	10
Hizentra	Human immunoglobulin G	18
Humalog	Insulin analog	10
Humira		26
Hydroxyzine	Antihistamine	11
Ibuprofen	Nonsteroidal anti-inflammatory drug	17
Infliximab-dyyb	Tumor necrosis factor blocker	13
Invega	Atypical antipsychotic	22
Invega Sustenna	Atypical antipsychotic	308
Invega Trinza	Atypical antipsychotic	21
Irinotecan hcl		11
Keppra		12
Kyprolis	Proteasome inhibitor	23
Leucovorin calcium	Folate analog	13
Levetiracetam		12
Lexapro	Serotonin reuptake inhibitor	21
Lipitor	HMG-CoA reductase inhibitor	15
Lisinopril	Angiotensin converting enzyme inhibitor	16
Lithium carbonate	Mood stabilizer	22
Lorazepam	Benzodiazepine	54
Metformin hcl	Biguanide	14
Methotrexate	Folate analog metabolic inhibitor	33
Metoclopramide	Dopamine-2 receptor antagonist	11
Midazolam	Benzodiazepine	19
Mirtazapine		10
Morphine	Opioid agonist	11
Morphine sulfate	Opioid agonist	19
Mvasi	Vascular endothelial growth factor inhibitor	50
Neulasta	Leukocyte growth factor	54
Neurontin		22
Norvasc	Calcium channel blocker	15
Nplate	Thrombopoietin receptor agonist	51
Nuplazid	Atypical antipsychotic	188
Olanzapine	Atypical antipsychotic	68
Opsumit	Endothelin receptor antagonist	18
Oxaliplatin	Platinum-based drug	11
Oxycodone hcl	Opioid agonist	10
OxyContin	Opioid agonist	24
Paclitaxel	Microtubule inhibitor	10
Paliperidone palmitate	Atypical antipsychotic	12
Peg-Intron		30
Pradaxa	Direct thrombin inhibitor	10
Prednisolone	Corticosteroid	17
Prednisone	Corticosteroid	42
Pregabalin		10
Procrit	Erythropoiesis-stimulating agent	13
Prograf	Calcineurin inhibitor immunosuppressant	10
Prolia	RANK ligand inhibitor	46
Quetiapine	Atypical antipsychotic	41
Rebetol		22
Rebif	Interferon beta	41
Remicade	Tumor necrosis factor blocker	24
Repatha	PCSK9 inhibitor	24
Revlimid	Thalidomide analog	48
Rexulti	Atypical antipsychotic	14
Ribavirin	Nucleoside analog antiviral	18
Risperdal	Atypical antipsychotic	50
Risperdal Consta		81
Risperidone	Atypical antipsychotic	52
Rituximab	CD20-directed cytolytic antibody	28
Tarceva		11
Taxol		23
Taxotere		10
Thalomid		19
Tracleer	Endothelin receptor antagonist	12
Trimethoprim	Dihydrofolate reductase inhibitor antibacterial	12
Truxima	CD20-directed cytolytic antibody	16
Vancomycin	Glycopeptide antibacterial	12
Vectibix	Epidermal growth factor receptor antagonist	19
Velcade	Proteasome inhibitor	20
Vincristine		10
Vincristine sulfate	Vinca alkaloid	11
Vioxx		36
Vivitrol		15
Warfarin	Vitamin K antagonist	18
Warfarin sodium	Vitamin K antagonist	37
Xeplion		10
Xgeva	RANK ligand inhibitor	93
Zoloft	Serotonin reuptake inhibitor	12
Zuclopenthixol		12
Zyprexa	Atypical antipsychotic	56

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 31 pharmacologic classes with 25 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 Refusal of treatment by patient name, in order of name
Class	Reports with this term
Alkylating drug	72
Anthracycline topoisomerase inhibitor	25
Anti-epileptic agent	45
Atypical antipsychotic	1,216
Benzodiazepine	119
Cardiac glycoside	74
CD20-directed cytolytic antibody	50
Corticosteroid	112
Endothelin receptor antagonist	49
Epidermal growth factor receptor antagonist	33
Erythropoiesis-stimulating agent	26
Folate analog metabolic inhibitor	41
Human immunoglobulin G	25
Interferon beta	60
Kinase inhibitor	32
Leukocyte growth factor	60
Mood stabilizer	30
Nonsteroidal anti-inflammatory drug	80
Nucleoside metabolic inhibitor	100
Opioid agonist	88
Platinum-based drug	114
Proteasome inhibitor	45
RANK ligand inhibitor	139
Serotonin and norepinephrine reuptake inhibitor	26
Serotonin reuptake inhibitor	95
Thalidomide analog	57
Thrombopoietin receptor agonist	51
Tumor necrosis factor blocker	113
Typical antipsychotic	38
Vascular endothelial growth factor inhibitor	239
Vitamin K antagonist	55

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

Reports by month

Reports that record Refusal of treatment by patient, 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 Refusal of treatment by patient
Age	Reports	Share
Under 2	10	0.2%
2 to 11	106	1.6%
12 to 17	75	1.2%
18 to 44	1,121	17.4%
45 to 64	1,488	23.2%
65 to 74	764	11.9%
75 and over	802	12.5%
Age not given	2,059	32%

Sex of the patient in the reports that record Refusal of treatment by patient
Sex	Reports	Share
Female	3,053	47.5%
Male	2,644	41.2%
Unknown or not given	728	11.3%

Age and sex are as the report gives them. 68.3% 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. Refusal of treatment by patient: adverse event reports that record this term. https://reportedreactions.com/reaction/refusal-of-treatment-by-patient/ 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 Refusal of treatment by patient 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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