Haemolytic anaemia 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 8,839 adverse event reports that record the MedDRA preferred term Haemolytic anaemia. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 454 reports in the 12 months to June 2026 and 463 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 1,036 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, 454 (under 0.1%) record this term. Reports for male patients were 42.5% 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 121 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 Haemolytic anaemia name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		64
Alecensa	Kinase inhibitor	44
Alemtuzumab	CD52-directed cytolytic antibody	49
Allopurinol	Xanthine oxidase inhibitor	51
Amlodipine	Calcium channel blocker	38
Amoxicillin	Penicillin-class antibacterial	40
Apomorphine hydrochloride	Dopaminergic agonist	34
Aripiprazole	Atypical antipsychotic	30
Aspirin	Nonsteroidal anti-inflammatory drug	63
Atorvastatin		50
Augmentin	Penicillin-class antibacterial	35
Avastin	Vascular endothelial growth factor inhibitor	62
Bactrim	Dihydrofolate reductase inhibitor antibacterial	86
Bendamustine		34
Bevacizumab	Vascular endothelial growth factor inhibitor	58
Capecitabine	Nucleoside metabolic inhibitor	36
Carboplatin	Platinum-based drug	178
Carfilzomib	Proteasome inhibitor	44
Ceftriaxone	Cephalosporin antibacterial	137
Ceftriaxone sodium	Cephalosporin antibacterial	26
CellCept	Antimetabolite immunosuppressant	30
Ciclosporin		25
Ciprofloxacin	Fluoroquinolone antibacterial	64
Cisplatin	Platinum-based drug	30
Clopidogrel	P2Y12 platelet inhibitor	30
Copegus		53
Cyclophosphamide	Alkylating drug	162
Cyclosporine	Calcineurin inhibitor immunosuppressant	84
Dapsone	Sulfone	146
Dexamethasone	Corticosteroid	122
Docetaxel	Microtubule inhibitor	29
Doxorubicin	Anthracycline topoisomerase inhibitor	26
Enbrel	Tumor necrosis factor blocker	27
Esomeprazole	Proton pump inhibitor	33
Etoposide	Topoisomerase inhibitor	51
Exjade	Iron chelator	30
Fluconazole	Azole antifungal	25
Fludara		34
Fludarabine	Nucleoside metabolic inhibitor	51
Fludarabine phosphate	Nucleoside metabolic inhibitor	39
Fluorouracil	Nucleoside metabolic inhibitor	60
Furosemide	Loop diuretic	48
GAMMAGARD Liquid	Human immunoglobulin G	40
Gamunex		33
Gemcitabine	Nucleoside metabolic inhibitor	64
Gemzar		29
Human immunoglobulin g	Human immunoglobulin G	142
Human Normal Immunoglobulin		28
Humira		58
Hydroxychloroquine	Antimalarial	47
Ibrutinib (form s4)	Kinase inhibitor	28
Ibuprofen	Nonsteroidal anti-inflammatory drug	65
Imbruvica	Kinase inhibitor	66
Ipilimumab	CTLA-4-directed blocking antibody	25
Isentress	Human immunodeficiency virus integrase strand transfer inhibitor	28
Keytruda	Programmed death Receptor-1 blocking antibody	60
Kyprolis	Proteasome inhibitor	43
Lemtrada	CD52-directed cytolytic antibody	42
Levetiracetam		36
Levofloxacin	Fluoroquinolone antibacterial	30
Linezolid	Oxazolidinone antibacterial	30
Lovenox	Low molecular weight heparin	42
Mabthera		36
Melphalan	Alkylating drug	26
Metformin	Biguanide	111
Metformin hydrochloride	Biguanide	50
Methotrexate	Folate analog metabolic inhibitor	135
Methylprednisolone	Corticosteroid	119
Metronidazole	Nitroimidazole antimicrobial	28
Mycophenolate mofetil	Antimetabolite immunosuppressant	120
Mycophenolic acid	Antimetabolite immunosuppressant	30
Neoral	Calcineurin inhibitor immunosuppressant	49
Nivolumab	Programmed death Receptor-1 blocking antibody	63
Olanzapine	Atypical antipsychotic	29
Omeprazole	Proton pump inhibitor	37
Ondansetron	Serotonin-3 receptor antagonist	29
Opdivo	Programmed death Receptor-1 blocking antibody	68
Oxaliplatin	Platinum-based drug	166
Paclitaxel	Microtubule inhibitor	56
Pantoprazole	Proton pump inhibitor	45
Paracetamol		56
Peg-Intron		27
Pegasys	Interferon alpha	120
Peginterferon alfa-2a	Interferon alpha	26
Pegintron		40
Pembrolizumab	Programmed death Receptor-1 blocking antibody	38
Pemetrexed	Folate analog metabolic inhibitor	30
Piperacillin and tazobactam	Penicillin-class antibacterial	34
Piperacillin sodium,tazobactam sodium		25
Plavix	P2Y12 platelet inhibitor	27
Prednisolone	Corticosteroid	104
Prednisone	Corticosteroid	155
Privigen	Human immunoglobulin G	97
Prograf	Calcineurin inhibitor immunosuppressant	73
Rasburicase		31
Rebetol		63
Revlimid	Thalidomide analog	72
Ribavirin	Nucleoside analog antiviral	320
Rifampicin		34
Rifampin	Rifamycin antibacterial	29
Rituxan	CD20-directed cytolytic antibody	57
Rituximab	CD20-directed cytolytic antibody	195
Rocephin		25
Simeprevir		49
Sofosbuvir	Hepatitis C virus nucleotide analog NS5B polymerase inhibitor	35
Soliris	Complement inhibitor	109
Sovriad		46
Sulfasalazine	Aminosalicylate	31
Tacrolimus	Calcineurin inhibitor immunosuppressant	165
Thymoglobulin	Immunoglobulin G	32
Treanda	Alkylating drug	26
Truvada	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	30
Tysabri	Integrin receptor antagonist	40
Vancomycin	Glycopeptide antibacterial	62
Velcade	Proteasome inhibitor	26
Venclexta	BCL-2 inhibitor	36
Venetoclax	BCL-2 inhibitor	39
Vincristine		41
Xarelto	Factor Xa inhibitor	45
Xeloda	Nucleoside metabolic inhibitor	38
Yervoy	CTLA-4-directed blocking antibody	37

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 45 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 Haemolytic anaemia name, in order of name
Class	Reports with this term
Alkylating drug	287
Anti-epileptic agent	60
Antimalarial	83
Antimetabolite immunosuppressant	183
Atypical antipsychotic	131
BCL-2 inhibitor	75
Benzodiazepine	82
beta-Adrenergic blocker	71
Biguanide	182
Calcineurin inhibitor immunosuppressant	385
CD20-directed cytolytic antibody	288
CD52-directed cytolytic antibody	100
Cephalosporin antibacterial	227
Complement inhibitor	120
Corticosteroid	548
CTLA-4-directed blocking antibody	62
Dihydrofolate reductase inhibitor antibacterial	108
Factor Xa inhibitor	71
Fluoroquinolone antibacterial	98
Folate analog metabolic inhibitor	203
Glycopeptide antibacterial	67
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	52
Hepatitis C virus nucleotide analog NS5B polymerase inhibitor	51
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	59
Human immunoglobulin G	337
Integrin receptor antagonist	77
Interferon alpha	146
Kinase inhibitor	283
Loop diuretic	57
Microtubule inhibitor	98
Nonsteroidal anti-inflammatory drug	200
Nucleoside analog antiviral	320
Nucleoside metabolic inhibitor	354
P2Y12 platelet inhibitor	59
Penicillin-class antibacterial	121
Platinum-based drug	374
Programmed death Receptor-1 blocking antibody	255
Proteasome inhibitor	120
Proton pump inhibitor	156
Sulfone	146
Thalidomide analog	106
Topoisomerase inhibitor	53
Tumor necrosis factor blocker	87
Vascular endothelial growth factor inhibitor	124
Xanthine oxidase inhibitor	58

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

Reports by month

Reports that record Haemolytic anaemia, 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 Haemolytic anaemia
Age	Reports	Share
Under 2	156	1.8%
2 to 11	379	4.3%
12 to 17	217	2.5%
18 to 44	1,351	15.3%
45 to 64	2,231	25.2%
65 to 74	1,287	14.6%
75 and over	931	10.5%
Age not given	2,287	25.9%

Sex of the patient in the reports that record Haemolytic anaemia
Sex	Reports	Share
Female	4,032	45.6%
Male	3,757	42.5%
Unknown or not given	1,050	11.9%

Age and sex are as the report gives them. 31.3% 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. Haemolytic anaemia: adverse event reports that record this term. https://reportedreactions.com/reaction/haemolytic-anaemia/ 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 Haemolytic anaemia 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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