Reported Reactions

Adverse event reports that FDA received

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Gait disturbance adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
difficulty walking

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 189,223 adverse event reports that record the MedDRA preferred term Gait disturbance. In plain words, the term means: difficulty walking. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 8,246 reports in the 12 months to June 2026 and 9,179 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 80 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, 8,246 (0.6%) record this term. Reports for female patients were 62.8% 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.

Plain meaning

Difficulty walking. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

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

Drugs in these reports

The table has the 130 drug pages with 500 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 Gait disturbance name as a suspect product, in order of name
DrugClassReports with this term
AbataceptSelective T cell costimulation modulator522
AbilifyAtypical antipsychotic563
Acetaminophen1,347
Acetaminophen Oxycodone Hydrochloride609
ActemraInterleukin-6 receptor antagonist2,856
AdalimumabTumor necrosis factor blocker1,105
Alendronate sodiumBisphosphonate1,224
Alendronic Acid592
AmlodipineCalcium channel blocker738
AmpyraPotassium channel blocker9,102
AravaAntirheumatic agent2,083
AspirinNonsteroidal anti-inflammatory drug527
Atorvastatin743
AubagioPyrimidine synthesis inhibitor1,702
AvonexInterferon beta5,459
Betaseron527
Calcium carbonateBlood coagulation factor655
Carbidopa levodopaAromatic amino acid1,183
CelebrexNonsteroidal anti-inflammatory drug1,325
CelecoxibNonsteroidal anti-inflammatory drug681
Certolizumab pegolTumor necrosis factor blocker757
CetirizineHistamine-1 receptor antagonist607
Cetirizine hydrochlorideHistamine-1 receptor antagonist1,097
Cetirizine hydrochloride, pseudoephedrine hydrochlorideHistamine-1 receptor antagonist649
Chlorhexidine532
CimziaTumor necrosis factor blocker1,674
CiprofloxacinFluoroquinolone antibacterial1,171
ClonazepamBenzodiazepine647
Codeine580
Copaxone1,025
CortisoneCorticosteroid649
Cortisone acetateCorticosteroid861
CosentyxInterleukin-17A antagonist3,326
CrestorHMG-CoA reductase inhibitor1,073
Cymbalta1,015
DalfampridinePotassium channel blocker685
DesoximetasoneCorticosteroid1,178
DexamethasoneCorticosteroid615
DiclofenacNonsteroidal anti-inflammatory drug1,174
Diclofenac potassiumNonsteroidal anti-inflammatory drug749
Diclofenac sodiumNonsteroidal anti-inflammatory drug1,565
Duodopa764
DupixentInterleukin-4 receptor alpha antagonist1,625
EliquisFactor Xa inhibitor735
EnbrelTumor necrosis factor blocker8,723
EntrestoAngiotensin 2 receptor blocker1,605
Erelzi1,306
FentanylOpioid agonist569
Flumethasone Pivalate611
Folic acid1,554
ForteoParathyroid hormone analog2,527
FosamaxBisphosphonate1,803
FurosemideLoop diuretic512
GabapentinAnti-epileptic agent1,307
GilenyaSphingosine 1-phosphate receptor modulator3,480
GolimumabTumor necrosis factor blocker553
HumalogInsulin analog760
Humira10,054
HydrocortisoneCorticosteroid771
HydroxychloroquineAntimalarial1,485
Hydroxychloroquine sulfateAntimalarial1,247
IbranceKinase inhibitor805
IbuprofenNonsteroidal anti-inflammatory drug560
InfliximabTumor necrosis factor blocker1,275
Isopropyl alcoholStandardized chemical allergen547
KesimptaCD20-directed cytolytic antibody1,381
KevzaraInterleukin-6 receptor antagonist1,164
KisqaliKinase inhibitor558
LamotrigineAnti-epileptic agent609
LeflunomideAntirheumatic agent2,126
Levaquin740
Levetiracetam538
LevofloxacinFluoroquinolone antibacterial798
LipitorHMG-CoA reductase inhibitor1,117
LisinoprilAngiotensin converting enzyme inhibitor520
LorazepamBenzodiazepine620
Lyrica4,428
MetforminBiguanide621
MethotrexateFolate analog metabolic inhibitor4,506
Methotrexate sodiumFolate analog metabolic inhibitor1,084
MorphineOpioid agonist588
Morphine sulfateOpioid agonist672
Mycophenolate mofetilAntimetabolite immunosuppressant698
NaproxenNonsteroidal anti-inflammatory drug621
Naproxen sodiumNonsteroidal anti-inflammatory drug689
NuplazidAtypical antipsychotic2,154
OcrevusCD20-directed cytolytic antibody2,280
OlanzapineAtypical antipsychotic565
OmeprazoleProton pump inhibitor591
OrenciaSelective T cell costimulation modulator2,921
OtezlaPhosphodiesterase 4 inhibitor938
OxycodoneOpioid agonist684
Oxycodone hydrochlorideOpioid agonist825
Oxycodone Terephthalate582
PantoprazoleProton pump inhibitor691
Phthalylsulfathiazole1,032
PlaquenilAntimalarial1,058
PrednisoneCorticosteroid3,045
Pregabalin972
ProliaRANK ligand inhibitor1,670
Pseudoephedrine hydrochloridealpha-Adrenergic agonist794
QuetiapineAtypical antipsychotic698
RamiprilAngiotensin converting enzyme inhibitor786
RebifInterferon beta1,435
ReclastBisphosphonate501
RemicadeTumor necrosis factor blocker2,149
RepathaPCSK9 inhibitor1,067
RevlimidThalidomide analog1,386
RinvoqJanus kinase inhibitor1,035
RisperidoneAtypical antipsychotic510
RituxanCD20-directed cytolytic antibody922
RituximabCD20-directed cytolytic antibody2,535
Sandostatin LAR Depot739
SeroquelAtypical antipsychotic604
SimponiTumor necrosis factor blocker1,613
SimvastatinHMG-CoA reductase inhibitor854
SkyriziInterleukin-23 antagonist617
StelaraInterleukin-12 antagonist1,058
SulfasalazineAminosalicylate2,271
SutentKinase inhibitor596
SymbicortCorticosteroid505
Tecfidera3,982
TocilizumabInterleukin-6 receptor antagonist622
Tramadol hydrochlorideOpioid agonist542
TysabriIntegrin receptor antagonist8,890
XareltoFactor Xa inhibitor524
XeljanzJanus kinase inhibitor3,949
XolairAnti-IgE761
XtandiAndrogen receptor inhibitor629
Zometa609

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 52 pharmacologic classes with 1,000 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 Gait disturbance name, in order of name
ClassReports with this term
Aminosalicylate2,578
Angiotensin 2 receptor blocker3,912
Angiotensin converting enzyme inhibitor1,499
Anti-epileptic agent4,298
Anti-IgE1,153
Anticholinergic1,041
Antimalarial3,795
Antirheumatic agent4,209
Aromatase inhibitor1,141
Aromatic amino acid2,352
Atypical antipsychotic8,130
Benzodiazepine3,233
beta-Adrenergic blocker1,761
Bisphosphonate4,319
Blood coagulation factor1,062
Calcium channel blocker1,178
CD20-directed cytolytic antibody7,579
Corticosteroid12,069
Endothelin receptor antagonist1,402
Factor Xa inhibitor1,620
Fluoroquinolone antibacterial2,374
Folate analog metabolic inhibitor5,690
GLP-1 receptor agonist1,263
Histamine-1 receptor antagonist3,129
HMG-CoA reductase inhibitor4,513
Insulin analog2,586
Integrin receptor antagonist9,566
Interferon beta7,492
Interleukin-12 antagonist1,370
Interleukin-17A antagonist3,622
Interleukin-4 receptor alpha antagonist1,753
Interleukin-6 receptor antagonist4,871
Janus kinase inhibitor6,446
Kinase inhibitor7,517
Mood stabilizer1,165
Nonsteroidal anti-inflammatory drug8,654
Nucleoside metabolic inhibitor1,129
Opioid agonist6,510
Parathyroid hormone analog2,709
PCSK9 inhibitor1,372
Phosphodiesterase 4 inhibitor1,382
Potassium channel blocker9,920
Programmed death Receptor-1 blocking antibody1,036
Proton pump inhibitor3,080
Pyrimidine synthesis inhibitor2,197
RANK ligand inhibitor1,846
Selective T cell costimulation modulator3,443
Serotonin and norepinephrine reuptake inhibitor1,256
Serotonin reuptake inhibitor2,655
Sphingosine 1-phosphate receptor modulator4,209
Thalidomide analog2,119
Tumor necrosis factor blocker19,173

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

Reports by month

Reports that record Gait disturbance, by month, five years to June 2026
01,0002,00020222023202420252026

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 Gait disturbance
AgeReportsShareShare as a bar
Under 22680.1%
2 to 111,6040.8%
12 to 171,3210.7%
18 to 4419,63510.4%
45 to 6447,32625%
65 to 7426,71014.1%
75 and over22,99112.2%
Age not given69,36836.7%
Sex of the patient in the reports that record Gait disturbance
SexReportsShareShare as a bar
Female118,76962.8%
Male59,48831.4%
Unknown or not given10,9665.8%

Age and sex are as the report gives them. 68.1% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Gait disturbance: adverse event reports that record this term. https://reportedreactions.com/reaction/gait-disturbance/ 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 Gait disturbance mean in an adverse event report?

In plain words: difficulty walking. 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 .