Reported Reactions

Adverse event reports that FDA received

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Photosensitivity reaction adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
skin reaction to sunlight

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 16,170 adverse event reports that record the MedDRA preferred term Photosensitivity reaction. In plain words, the term means: skin reaction to sunlight. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 831 reports in the 12 months to June 2026 and 830 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 704 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, 831 (0.1%) record this term. Reports for patients aged 45 to 64 were 25.7% of the reports that record this term and 20% 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

Skin reaction to sunlight. 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 93 drug pages with 50 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 Photosensitivity reaction name as a suspect product, in order of name
DrugClassReports with this term
ActemraInterleukin-6 receptor antagonist198
AlecensaKinase inhibitor69
AllopurinolXanthine oxidase inhibitor64
Amiodarone75
AmlodipineCalcium channel blocker116
AnakinraInterleukin-1 receptor antagonist109
AravaAntirheumatic agent167
Atorvastatin113
AvonexInterferon beta71
AyvakitKinase inhibitor108
AzathioprinePurine antimetabolite78
BactrimDihydrofolate reductase inhibitor antibacterial51
Cannabis Sativa52
CimziaTumor necrosis factor blocker79
CiprofloxacinFluoroquinolone antibacterial262
ClonazepamBenzodiazepine54
CobimetinibKinase inhibitor67
CosentyxInterleukin-17A antagonist122
CotellicKinase inhibitor61
CyclosporineCalcineurin inhibitor immunosuppressant66
Cymbalta74
DocetaxelMicrotubule inhibitor63
DoxycyclineTetracycline-class drug308
Doxycycline hyclateTetracycline-class drug52
DupixentInterleukin-4 receptor alpha antagonist472
EliquisFactor Xa inhibitor60
EnbrelTumor necrosis factor blocker542
EsbrietPyridone628
FurosemideLoop diuretic68
GabapentinAnti-epileptic agent92
GilenyaSphingosine 1-phosphate receptor modulator79
GoldStandardized chemical allergen124
Humira769
HydrochlorothiazideThiazide diuretic86
HydroxychloroquineAntimalarial128
Hydroxychloroquine sulfateAntimalarial115
IbuprofenNonsteroidal anti-inflammatory drug85
Ilaris97
IsotretinoinRetinoid51
LamictalAnti-epileptic agent94
LamotrigineAnti-epileptic agent90
LansoprazoleProton pump inhibitor74
LeflunomideAntirheumatic agent150
Levaquin53
LevofloxacinFluoroquinolone antibacterial64
LipitorHMG-CoA reductase inhibitor51
Lyrica94
MetforminBiguanide67
MethotrexateFolate analog metabolic inhibitor483
Methotrexate sodiumFolate analog metabolic inhibitor137
MinocyclineTetracycline-class drug121
Minocycline hydrochlorideTetracycline-class drug116
Mycophenolate mofetilAntimetabolite immunosuppressant120
NiraparibPoly(ADP-Ribose) polymerase inhibitor133
Olysio103
OmalizumabAnti-IgE68
OmeprazoleProton pump inhibitor105
OrenciaSelective T cell costimulation modulator208
OtezlaPhosphodiesterase 4 inhibitor67
OxycodoneOpioid agonist98
PaclitaxelMicrotubule inhibitor56
PantoprazoleProton pump inhibitor71
PaxilSerotonin reuptake inhibitor53
PegasysInterferon alpha109
PirfenidonePyridone94
PlaquenilAntimalarial169
PrednisoloneCorticosteroid91
PrednisoneCorticosteroid227
Pregabalin74
RemicadeTumor necrosis factor blocker264
RevlimidThalidomide analog106
RibavirinNucleoside analog antiviral137
RituxanCD20-directed cytolytic antibody76
RituximabCD20-directed cytolytic antibody178
RubracaPoly(ADP-Ribose) polymerase inhibitor171
SertralineSerotonin reuptake inhibitor84
Simeprevir72
SimvastatinHMG-CoA reductase inhibitor76
Sodium Aurothiomalate68
SofosbuvirHepatitis C virus nucleotide analog NS5B polymerase inhibitor72
SovaldiHepatitis C virus nucleotide analog NS5B polymerase inhibitor80
Sulfamethoxazole, trimethoprimDihydrofolate reductase inhibitor antibacterial58
SulfasalazineAminosalicylate216
TacrolimusCalcineurin inhibitor immunosuppressant140
Tecfidera73
TysabriIntegrin receptor antagonist86
VemurafenibKinase inhibitor149
VfendAzole antifungal166
VoriconazoleAzole antifungal454
XeljanzJanus kinase inhibitor202
XolairAnti-IgE107
ZejulaPoly(ADP-Ribose) polymerase inhibitor228
ZelborafKinase inhibitor262

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 46 pharmacologic classes with 100 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 Photosensitivity reaction name, in order of name
ClassReports with this term
Aminosalicylate233
Angiotensin 2 receptor blocker189
Anti-epileptic agent320
Anti-IgE175
Antimalarial418
Antimetabolite immunosuppressant147
Antirheumatic agent317
Atypical antipsychotic292
Azole antifungal671
Benzodiazepine156
beta-Adrenergic blocker164
Calcineurin inhibitor immunosuppressant260
Calcium channel blocker134
CD20-directed cytolytic antibody339
Corticosteroid559
Dihydrofolate reductase inhibitor antibacterial156
Factor Xa inhibitor105
Fluoroquinolone antibacterial375
Folate analog metabolic inhibitor629
Hepatitis C virus nucleotide analog NS5B polymerase inhibitor152
HMG-CoA reductase inhibitor254
Integrin receptor antagonist119
Interferon alpha118
Interleukin-1 receptor antagonist111
Interleukin-17A antagonist137
Interleukin-4 receptor alpha antagonist490
Interleukin-6 receptor antagonist216
Janus kinase inhibitor272
Kinase inhibitor1,411
Microtubule inhibitor129
Nonsteroidal anti-inflammatory drug336
Nucleoside analog antiviral137
Nucleoside metabolic inhibitor110
Opioid agonist269
Poly(ADP-Ribose) polymerase inhibitor537
Programmed death Receptor-1 blocking antibody122
Proton pump inhibitor357
Pyridone722
Retinoid174
Selective T cell costimulation modulator227
Serotonin and norepinephrine reuptake inhibitor143
Serotonin reuptake inhibitor355
Standardized chemical allergen124
Tetracycline-class drug608
Thalidomide analog123
Tumor necrosis factor blocker1,075

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

Reports by month

Reports that record Photosensitivity reaction, 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 Photosensitivity reaction
AgeReportsShareShare as a bar
Under 2230.1%
2 to 112701.7%
12 to 172821.7%
18 to 442,73516.9%
45 to 644,16325.7%
65 to 741,93812%
75 and over1,0796.7%
Age not given5,68035.1%
Sex of the patient in the reports that record Photosensitivity reaction
SexReportsShareShare as a bar
Female8,96355.4%
Male5,62334.8%
Unknown or not given1,5849.8%

Age and sex are as the report gives them. 57% of these reports give the United States as the country.

Terms near this one

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

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

In plain words: skin reaction to sunlight. 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 .