Subdural haematoma 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 14,146 adverse event reports that record the MedDRA preferred term Subdural haematoma. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 646 reports in the 12 months to June 2026 and 601 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 123 drug pages with 25 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 Subdural haematoma name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		27
Acetylsalicylic Acid		355
Alprazolam	Benzodiazepine	28
Ambrisentan	Endothelin receptor antagonist	27
Amiodarone		39
Amlodipine	Calcium channel blocker	60
Apixaban	Factor Xa inhibitor	459
Arixtra	Factor Xa inhibitor	94
Aspirin	Nonsteroidal anti-inflammatory drug	843
Atorvastatin		57
Avandia		29
Avonex	Interferon beta	41
Azacitidine	Nucleoside metabolic inhibitor	79
Baclofen	gamma-Aminobutyric acid-ergic agonist	31
Bayaspirin		37
Bayer Low Dose	Nonsteroidal anti-inflammatory drug	44
Bisoprolol	beta-Adrenergic blocker	39
Brilinta	P2Y12 platelet inhibitor	36
Brilique		60
Carbidopa levodopa	Aromatic amino acid	36
Carboplatin	Platinum-based drug	32
Cardioaspirin		60
Carvedilol	alpha-Adrenergic blocker	25
Cisplatin	Platinum-based drug	40
Citalopram	Serotonin reuptake inhibitor	46
Clexane		33
Clopidogrel	P2Y12 platelet inhibitor	636
Clopidogrel bisulfate	P2Y12 platelet inhibitor	73
Cordarone		53
Coumadin		349
Coumadine		135
Cyclophosphamide	Alkylating drug	200
Cymbalta	Serotonin and norepinephrine reuptake inhibitor	27
Cytarabine	Nucleoside metabolic inhibitor	148
Dabigatran		46
Dabigatran etexilate mesylate	Direct thrombin inhibitor	43
Dasatinib	Kinase inhibitor	26
Daunorubicin		28
Dexamethasone	Corticosteroid	184
Digoxin	Cardiac glycoside	39
Doxorubicin	Anthracycline topoisomerase inhibitor	43
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	29
Duodopa		37
Edoxaban		25
Edoxaban tosylate (monohydrate)	Factor Xa inhibitor	26
Effient	P2Y12 platelet inhibitor	50
Eliquis	Factor Xa inhibitor	689
Enbrel	Tumor necrosis factor blocker	34
Enoxaparin		50
Enoxaparin sodium	Low molecular weight heparin	56
Entresto	Angiotensin 2 receptor blocker	37
Escitalopram	Serotonin reuptake inhibitor	75
Etoposide	Topoisomerase inhibitor	79
Evenity		30
Fentanyl	Opioid agonist	34
Fludarabine	Nucleoside metabolic inhibitor	31
Forteo	Parathyroid hormone analog	41
Furosemide	Loop diuretic	71
Gabapentin	Anti-epileptic agent	26
Gleevec	Kinase inhibitor	51
Glivec		31
Heparin		155
Heparin sodium	Anti-coagulant	68
Humira		79
Ibrutinib	Kinase inhibitor	101
Ibuprofen	Nonsteroidal anti-inflammatory drug	68
Imbruvica	Kinase inhibitor	244
Jakavi		36
Kardegic		266
Keppra		31
Lasilix		26
Leqembi		26
Levetiracetam		40
Levofloxacin	Fluoroquinolone antibacterial	25
Lixiana		40
Lorazepam	Benzodiazepine	30
Lovenox	Low molecular weight heparin	123
Methotrexate	Folate analog metabolic inhibitor	187
Metoprolol	beta-Adrenergic blocker	25
Mycophenolate mofetil	Antimetabolite immunosuppressant	41
Nivolumab	Programmed death Receptor-1 blocking antibody	26
Omeprazole	Proton pump inhibitor	36
Oncaspar	Asparagine-specific enzyme	25
Opdivo	Programmed death Receptor-1 blocking antibody	33
Opsumit	Endothelin receptor antagonist	57
Paroxetine	Serotonin reuptake inhibitor	62
Plavix	P2Y12 platelet inhibitor	356
Pradaxa	Direct thrombin inhibitor	781
Prazaxa		104
Prednisolone	Corticosteroid	44
Prednisone	Corticosteroid	107
Previscan		161
Remodulin	Prostacycline vasodilator	55
Revlimid	Thalidomide analog	172
Rituximab	CD20-directed cytolytic antibody	163
Rivaroxaban	Factor Xa inhibitor	170
Sertraline	Serotonin reuptake inhibitor	53
Simvastatin	HMG-CoA reductase inhibitor	39
Sintrom		70
Soliris	Complement inhibitor	29
Sprycel	Kinase inhibitor	34
Tacrolimus	Calcineurin inhibitor immunosuppressant	51
Tadalafil	Phosphodiesterase 5 inhibitor	26
Tahor		25
Tecfidera		30
Thalomid		29
Ticagrelor	P2Y12 platelet inhibitor	28
Tracleer	Endothelin receptor antagonist	33
Tysabri	Integrin receptor antagonist	64
Uptravi	Prostacyclin receptor agonist	25
Velcade	Proteasome inhibitor	36
Venclexta	BCL-2 inhibitor	34
Venetoclax	BCL-2 inhibitor	83
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	48
Vidaza	Nucleoside metabolic inhibitor	39
Vincristine		69
Vincristine sulfate	Vinca alkaloid	66
Warfarin	Vitamin K antagonist	612
Warfarin sodium	Vitamin K antagonist	385
Xarelto	Factor Xa inhibitor	1,471
Xtandi	Androgen receptor inhibitor	57
Zoloft	Serotonin reuptake inhibitor	26
Zometa		33

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 44 pharmacologic classes with 50 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 Subdural haematoma name, in order of name
Class	Reports with this term
Alkylating drug	274
Androgen receptor inhibitor	92
Angiotensin 2 receptor blocker	90
Anthracycline topoisomerase inhibitor	83
Anti-coagulant	88
Anti-epileptic agent	81
Antimetabolite immunosuppressant	59
Aromatic amino acid	52
Atypical antipsychotic	157
BCL-2 inhibitor	117
Benzodiazepine	94
beta-Adrenergic blocker	132
Calcineurin inhibitor immunosuppressant	88
Calcium channel blocker	71
CD20-directed cytolytic antibody	206
Corticosteroid	383
Direct thrombin inhibitor	835
Endothelin receptor antagonist	139
Factor Xa inhibitor	2,909
Folate analog metabolic inhibitor	211
HMG-CoA reductase inhibitor	102
Integrin receptor antagonist	70
Interferon beta	63
Kinase inhibitor	626
Loop diuretic	106
Low molecular weight heparin	179
Nonsteroidal anti-inflammatory drug	1,017
Nucleoside metabolic inhibitor	375
Opioid agonist	112
P2Y12 platelet inhibitor	1,200
Phosphodiesterase 5 inhibitor	59
Platinum-based drug	90
Programmed death Receptor-1 blocking antibody	91
Prostacycline vasodilator	100
Proteasome inhibitor	88
Proton pump inhibitor	125
Serotonin and norepinephrine reuptake inhibitor	120
Serotonin reuptake inhibitor	339
Thalidomide analog	227
Topoisomerase inhibitor	88
Tumor necrosis factor blocker	70
Vascular endothelial growth factor inhibitor	57
Vinca alkaloid	66
Vitamin K antagonist	997

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

Reports by month

Reports that record Subdural haematoma, 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 Subdural haematoma
Age	Reports	Share
Under 2	58	0.4%
2 to 11	91	0.6%
12 to 17	72	0.5%
18 to 44	626	4.4%
45 to 64	2,052	14.5%
65 to 74	2,817	19.9%
75 and over	5,568	39.4%
Age not given	2,862	20.2%

Sex of the patient in the reports that record Subdural haematoma
Sex	Reports	Share
Female	5,213	36.9%
Male	7,732	54.7%
Unknown or not given	1,201	8.5%

Age and sex are as the report gives them. 46.1% 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. Subdural haematoma: adverse event reports that record this term. https://reportedreactions.com/reaction/subdural-haematoma/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 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 Subdural haematoma 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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