Doxycycline Monohydrate side effects: what 1,579 FDA adverse event reports show
Drug class
Tetracycline-class Drug
Who reports
1,579 reports · 72% serious · 105 with death outcome · 63% female
Used for
Doxycycline is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ( 1.1 ) Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections.
What it is
Doxycycline Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22 H 24 N 2 O 8 ).
Boxed warning
None in the current label
Causality screen of the 20 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 5 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Photosensitivity reaction (sun sensitivity) | 18 | 14.5 9.2–23.0ROR 14.7 · χ² 214 / p 1e-48 | 13.8 EB05 8.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.3 | no trial data cached |
| Renal pain | 10 | 12.6 6.8–23.3ROR 12.7 · χ² 95 / p 8e-23 | 10.6 EB05 5.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.7 | no trial data cached |
| Chronic kidney disease | 66 | 11.4 9.0–14.5ROR 11.9 · χ² 620 / p 3e-137 | 11.2 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Pharyngeal oedema | 12 | 10.2 5.8–18.0ROR 10.3 · χ² 91 / p 8e-22 | 8.5 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| End stage renal disease | 14 | 10.1 6.0–17.0ROR 10.2 · χ² 106 / p 4e-25 | 8.6 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Economic problem | 11 | 9.5 5.3–17.1ROR 9.5 · χ² 75 / p 2e-18 | 7.6 EB05 4.3 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 | no trial data cached |
| Ear discomfort | 6 | 7.8 3.5–17.3ROR 7.8 · χ² 29 / p 4e-8 | 5.3 EB05 2.6 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Joint dislocation | 6 | 7.6 3.4–16.8ROR 7.6 · χ² 28 / p 6e-8 | 5.2 EB05 2.5 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Oesophagitis | 6 | 7.3 3.3–16.2ROR 7.3 · χ² 27 / p 1e-7 | 5.0 EB05 2.5 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Mass | 7 | 6.6 3.2–13.9ROR 6.7 · χ² 28 / p 6e-8 | 4.9 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Swollen tongue | 15 | 6.4 3.9–10.5ROR 6.4 · χ² 63 / p 1e-15 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Anhedonia | 12 | 6.0 3.4–10.6ROR 6.1 · χ² 45 / p 8e-12 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Lip swelling | 14 | 5.6 3.3–9.4ROR 5.6 · χ² 48 / p 2e-12 | 4.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Paranoia | 7 | 5.4 2.6–11.2ROR 5.4 · χ² 21 / p 3e-6 | 4.1 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Renal injury | 12 | 5.3 3.0–9.3ROR 5.3 · χ² 38 / p 4e-10 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 | no trial data cached |
| Tendonitis | 6 | 5.1 2.3–11.4ROR 5.1 · χ² 16 / p 3e-5 | 3.8 EB05 1.9 · IC025 +0.5 | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 10 | 4.9 2.7–9.1ROR 4.9 · χ² 27 / p 8e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Product dose omission | 18 | 3.6 2.3–5.7ROR 3.6 · χ² 31 / p 1e-8 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Pain of skin | 6 | 3.0 1.3–6.6ROR 3.0 · χ² 6 / p 0.007 | 2.6 EB05 1.3 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 6.0 | no trial data cached |
| Multiple sclerosis | 8 | 2.2 1.1–4.4ROR 2.2 · χ² 4 / p 0.021 | 2.1 EB05 1.2 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 66 | 11.4 9.0–14.5ROR 11.9 · χ² 620 / p 3e-137 | 11.2 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Product dose omission | 18 | 3.6 2.3–5.7ROR 3.6 · χ² 31 / p 1e-8 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 18 | 14.5 9.2–23.0ROR 14.7 · χ² 214 / p 1e-48 | 13.8 EB05 8.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.3 | no trial data cached |
| Swollen tongue | 15 | 6.4 3.9–10.5ROR 6.4 · χ² 63 / p 1e-15 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Lip swelling | 14 | 5.6 3.3–9.4ROR 5.6 · χ² 48 / p 2e-12 | 4.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| End stage renal disease | 14 | 10.1 6.0–17.0ROR 10.2 · χ² 106 / p 4e-25 | 8.6 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Renal injury | 12 | 5.3 3.0–9.3ROR 5.3 · χ² 38 / p 4e-10 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 | no trial data cached |
| Anhedonia | 12 | 6.0 3.4–10.6ROR 6.1 · χ² 45 / p 8e-12 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Pharyngeal oedema | 12 | 10.2 5.8–18.0ROR 10.3 · χ² 91 / p 8e-22 | 8.5 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Economic problem | 11 | 9.5 5.3–17.1ROR 9.5 · χ² 75 / p 2e-18 | 7.6 EB05 4.3 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 10 | 4.9 2.7–9.1ROR 4.9 · χ² 27 / p 8e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Renal pain | 10 | 12.6 6.8–23.3ROR 12.7 · χ² 95 / p 8e-23 | 10.6 EB05 5.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.7 | no trial data cached |
| Multiple sclerosis | 8 | 2.2 1.1–4.4ROR 2.2 · χ² 4 / p 0.021 | 2.1 EB05 1.2 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Paranoia | 7 | 5.4 2.6–11.2ROR 5.4 · χ² 21 / p 3e-6 | 4.1 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Mass | 7 | 6.6 3.2–13.9ROR 6.7 · χ² 28 / p 6e-8 | 4.9 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Chronic kidney disease — n=66, PRR 11.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Doxycycline (tetracyclines) ↔ Photosensitivity reaction.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Doxycycline?
In FDA FAERS, the most frequently co-reported reaction terms for Doxycycline are chronic kidney disease, photosensitivity reaction, swollen tongue, lip swelling, end stage renal disease, renal injury. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Doxycycline have an FDA boxed warning?
No. The FDA label retrieved for Doxycycline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Doxycycline causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0e6b3e17-aeee-4910-8e94-c7ac925b9cca, effective 20250415; matched on
openfda.generic_name.exact:"DOXYCYCLINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 25 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.