Reported Reactions

Adverse event reports that FDA received

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Cystitis 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 . The data have the reports that FDA received through .

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 .

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 .

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 31,450 adverse event reports that record the MedDRA preferred term Cystitis. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,199 reports in the 12 months to June 2026 and 1,360 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 535 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, 1,199 (0.1%) record this term. Reports for female patients were 75.7% 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 134 drug pages with 100 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 .

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 . The site read the page on .

Drugs that the reports with the term Cystitis name as a suspect product, in order of name
DrugClassReports with this term
AbataceptSelective T cell costimulation modulator153
Acetaminophen242
ActemraInterleukin-6 receptor antagonist484
Albuterolbeta2-Adrenergic agonist156
AlemtuzumabCD52-directed cytolytic antibody113
Alendronate sodiumBisphosphonate112
Aliskiren hemifumarateRenin inhibitor147
Altace182
Amitriptyline163
AmlodipineCalcium channel blocker169
Amlodipine besylateDihydropyridine calcium channel blocker144
AmpyraPotassium channel blocker383
AspirinNonsteroidal anti-inflammatory drug191
AtacandAngiotensin 2 receptor blocker144
AtroventAnticholinergic132
AubagioPyrimidine synthesis inhibitor138
AvonexInterferon beta628
Bisoprololbeta-Adrenergic blocker204
Breo ElliptaCorticosteroid110
BupropionAminoketone134
ByettaGLP-1 receptor agonist105
Calcium carbonateBlood coagulation factor176
CandesartanAngiotensin 2 receptor blocker150
Candesartan cilexetilAngiotensin 2 receptor blocker109
CarboplatinPlatinum-based drug128
Cefuroxime axetilCephalosporin antibacterial145
CelebrexNonsteroidal anti-inflammatory drug255
Certolizumab pegolTumor necrosis factor blocker136
CimziaTumor necrosis factor blocker197
CiprofloxacinFluoroquinolone antibacterial225
Ciprofloxacin hydrochlorideFluoroquinolone antibacterial119
ClarithromycinMacrolide antimicrobial113
ClopidogrelP2Y12 platelet inhibitor175
Codeine111
CosentyxInterleukin-17A antagonist643
CyclophosphamideAlkylating drug256
CyclosporineCalcineurin inhibitor immunosuppressant144
Cymbalta232
DexamethasoneCorticosteroid200
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose139
Diphenhydramine hydrochlorideHistamine-1 receptor antagonist134
DupixentInterleukin-4 receptor alpha antagonist219
EliquisFactor Xa inhibitor132
EnbrelTumor necrosis factor blocker1,623
ErgocalciferolProvitamin D2 compound253
EsomeprazoleProton pump inhibitor131
Esomeprazole magnesiumProton pump inhibitor103
EtoposideTopoisomerase inhibitor131
Ferrous gluconate154
FloventCorticosteroid126
ForteoParathyroid hormone analog374
FosamaxBisphosphonate204
FurosemideLoop diuretic191
GabapentinAnti-epileptic agent266
GilenyaSphingosine 1-phosphate receptor modulator274
Gliclazide171
GravolHistamine-1 receptor antagonist327
Human immunoglobulin gHuman immunoglobulin G230
Humira1,782
IbranceKinase inhibitor175
ImbruvicaKinase inhibitor253
InflectraTumor necrosis factor blocker198
InfliximabTumor necrosis factor blocker170
IrbesartanAngiotensin 2 receptor blocker189
JakafiJanus kinase inhibitor160
JanuviaDipeptidyl peptidase 4 inhibitor176
JardianceSodium-Glucose cotransporter 2 inhibitor124
Ketamine180
KisqaliKinase inhibitor131
LeflunomideAntirheumatic agent125
LetrozoleAromatase inhibitor137
Levothyroxine sodiuml-Thyroxine148
LipitorHMG-CoA reductase inhibitor218
LisinoprilAngiotensin converting enzyme inhibitor216
Lyrica216
MetforminBiguanide268
MethotrexateFolate analog metabolic inhibitor878
Methotrexate sodiumFolate analog metabolic inhibitor178
MethylprednisoloneCorticosteroid142
Methylprednisolone sodium succinateCorticosteroid221
MirenaProgestin123
MorphineOpioid agonist162
Morphine sulfateOpioid agonist135
MoxifloxacinFluoroquinolone antibacterial102
Mycophenolate mofetilAntimetabolite immunosuppressant166
Myrbetriqbeta3-Adrenergic agonist109
Naproxen sodiumNonsteroidal anti-inflammatory drug169
NexiumProton pump inhibitor178
NitrofurantoinNitrofuran antibacterial144
NitroglycerinNitrate vasodilator145
NuplazidAtypical antipsychotic108
OcrevusCD20-directed cytolytic antibody581
OmeprazoleProton pump inhibitor106
OndansetronSerotonin-3 receptor antagonist154
OpsumitEndothelin receptor antagonist117
OrenciaSelective T cell costimulation modulator251
OtezlaPhosphodiesterase 4 inhibitor129
PaclitaxelMicrotubule inhibitor133
Perindopril135
PomalystThalidomide analog188
Potassium chlorideOsmotic laxative159
PrednisoloneCorticosteroid140
PrednisoneCorticosteroid819
PremarinEstrogen123
ProchlorperazinePhenothiazine171
ProliaRANK ligand inhibitor806
RamiprilAngiotensin converting enzyme inhibitor126
RebifInterferon beta298
RemicadeTumor necrosis factor blocker401
RepathaPCSK9 inhibitor107
RevlimidThalidomide analog558
RinvoqJanus kinase inhibitor222
RituxanCD20-directed cytolytic antibody160
RituximabCD20-directed cytolytic antibody648
SandostatinSomatostatin analog118
Sandostatin LAR Depot152
Senokot168
SimponiTumor necrosis factor blocker211
SkyriziInterleukin-23 antagonist136
StelaraInterleukin-12 antagonist174
Sulfamethoxazole, trimethoprimDihydrofolate reductase inhibitor antibacterial127
SulfasalazineAminosalicylate105
Synthroidl-Thyroxine159
TacrolimusCalcineurin inhibitor immunosuppressant144
Tecfidera391
Tiotropium bromideAnticholinergic280
TracleerEndothelin receptor antagonist114
Tylenol with Codeine112
TysabriIntegrin receptor antagonist1,327
VedolizumabIntegrin receptor antagonist225
Vioxx212
XareltoFactor Xa inhibitor108
XeljanzJanus kinase inhibitor724
XolairAnti-IgE118

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 250 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 .

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 . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Cystitis name, in order of name
ClassReports with this term
Alkylating drug386
Angiotensin 2 receptor blocker826
Angiotensin converting enzyme inhibitor422
Anti-epileptic agent347
Anticholinergic534
Atypical antipsychotic307
beta-Adrenergic blocker351
Biguanide379
Bisphosphonate392
Calcineurin inhibitor immunosuppressant373
CD20-directed cytolytic antibody1,609
Cephalosporin antibacterial304
Corticosteroid2,205
Endothelin receptor antagonist423
Estrogen279
Factor Xa inhibitor294
Fluoroquinolone antibacterial586
Folate analog metabolic inhibitor1,074
GLP-1 receptor agonist271
Histamine-1 receptor antagonist645
HMG-CoA reductase inhibitor420
Human immunoglobulin G403
Insulin analog308
Integrin receptor antagonist1,609
Interferon beta978
Interleukin-17A antagonist729
Interleukin-6 receptor antagonist593
Janus kinase inhibitor1,162
Kinase inhibitor1,312
l-Thyroxine309
Nonsteroidal anti-inflammatory drug1,011
Nucleoside metabolic inhibitor469
Opioid agonist497
Osmotic laxative261
Parathyroid hormone analog387
Potassium channel blocker439
Proton pump inhibitor879
Provitamin D2 compound259
RANK ligand inhibitor867
Selective T cell costimulation modulator404
Sodium-Glucose cotransporter 2 inhibitor326
Sphingosine 1-phosphate receptor modulator345
Thalidomide analog834
Tumor necrosis factor blocker3,107

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

Reports by month

Reports that record Cystitis, by month, five years to June 2026
010020020222023202420252026

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 Cystitis
AgeReportsShareShare as a bar
Under 2300.1%
2 to 111470.5%
12 to 171130.4%
18 to 442,8499.1%
45 to 647,83024.9%
65 to 745,19516.5%
75 and over4,71615%
Age not given10,57033.6%
Sex of the patient in the reports that record Cystitis
SexReportsShareShare as a bar
Female23,80175.7%
Male5,49117.5%
Unknown or not given2,1586.9%

Age and sex are as the report gives them. 63.9% 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

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Reported Reactions. Cystitis: adverse event reports that record this term. https://reportedreactions.com/reaction/cystitis/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

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 Cystitis 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 .

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 .

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 .