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Causality assessment · Causality: well established

Doxycycline (tetracyclines) and Photosensitivity reaction: is the FAERS signal real?

n=427 co-reports · PRR 8.2 · ROR 8.3
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Causality: well established

Doxycycline (tetracyclines) ↔ Photosensitivity reaction

n=427 co-reports · PRR 8.2 · ROR 8.3

Doxycycline is one of the most phototoxic antibiotics: it accumulates in the skin, absorbs ultraviolet light, and produces an exaggerated sunburn-like reaction on exposed areas. It is a genuine, well-characterised chemical phototoxicity rather than an allergy, and it is common enough that sunscreen and sun-avoidance counselling is standard when the drug is prescribed. The 427 co-reports (PRR 8.2) reflect both the real effect and doxycycline's very wide use for acne, tick-borne infections, and malaria prophylaxis.

Regulatory basis: doxycycline prescribing information (photosensitivity warning; sun-protection advice). Established tetracycline phototoxicity literature.

Bradford Hill viewpointStatusNote
Temporality (necessary)metThe reaction appears during sun exposure while taking the drug and settles after withdrawal
StrengthpartialPRR 8 with a moderate co-report count
ConsistencymetReproduced across tetracyclines and in dermatology practice
SpecificitymetDrug-induced phototoxicity has a characteristic photodistributed pattern
Biological gradientpartialBroadly dose- and exposure-related (drug dose and UV exposure)
PlausibilitymetUltraviolet absorption by the drug in the skin is the defined mechanism
CoherencemetCoheres with the routine sun-protection counselling given with doxycycline
ExperimentpartialDechallenge (withdrawal plus sun avoidance) resolves it; no randomized trial
AnalogymetAnalogous to phototoxicity with other tetracyclines and some other drugs

This page's own qualitative read, not an automated/citation-gated assessment.

✗ No ClinicalTrials.gov results-posting trial in the top search hits for doxycycline captured photosensitivity; the reaction depends on ambient sun exposure and is managed in clinic rather than captured as a coded trial AE.