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Drug · FAERS side-effect profile with label screen

Doxycycline side effects: what 67,795 FDA adverse event reports show

Doxycycline · 1,201 reaction terms · 384,622 drug–reaction co-reports · data 2026-09-14
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Drug class

Tetracycline-class Drug

FDA label (Established Pharmacologic Class)

Who reports

67,795 reports · 72% serious · 6,693 with death outcome · 63% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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 ).

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled (related wording) 2Lab value / disease marker 7Not in label — unassessed 31
What the badges mean

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,161 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Amyloid arthropathy551,858.1
918.3–3,759.4ROR 1,859.6 · calibrated p 6e-17 ✓
240.3 EB05 191.6 · IC025 +5.8
3/3 methods agree
Not in label — unassessedserious n=55 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Grip strength142496.3
380.1–648.0ROR 497.3 · calibrated p 2e-13 ✓
184.5 EB05 160.4 · IC025 +6.6
3/3 methods agree
Not in label — unassessedserious n=142 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Congenital hiatus hernia119361.8
277.4–472.0ROR 362.5 · calibrated p 3e-12 ✓
161.5 EB05 138.6 · IC025 +6.3
3/3 methods agree
Not in label — unassessedserious n=119 · ♀ 0% (drug 63%)not reported in cached trials
C-reactive protein462323.7
284.0–368.9ROR 325.9 · calibrated p 5e-12 ✓
156.3 EB05 144.7 · IC025 +6.9
3/3 methods agree
Lab value / disease markerserious n=462 · ♀ 100% (drug 63%) · 97% cliniciannot reported in cached trials
Deep vein thrombosis postoperative869247.6
226.5–270.7ROR 250.8 · calibrated p 5e-11 ✓
136.5 EB05 129.1 · IC025 +6.9
3/3 methods agree
Not in label — unassessedserious n=869 · ♀ 100% (drug 63%) · 95% cliniciannot reported in cached trials
Anti-cyclic citrullinated peptide antibody295246.4
211.4–287.3ROR 247.5 · calibrated p 7e-11 ✓
135.4 EB05 122.9 · IC025 +6.6
3/3 methods agree
Lab value / disease markerserious n=295 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Jarisch-herxheimer reaction309237.3
204.5–275.3ROR 238.3 · calibrated p 1e-10 ✓
132.6 EB05 120.7 · IC025 +6.6
3/3 methods agree
Not in label — unassessedserious n=294 · ♀ 28% (drug 63%) · 100% cliniciannot reported in cached trials
Swollen joint count106235.2
182.6–303.1ROR 235.6 · calibrated p 2e-10 ✓
130.0 EB05 110.5 · IC025 +6.0
3/3 methods agree
Not in label — unassessedserious n=106 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Lupus vulgaris509232.4
207.1–260.7ROR 234.1 · calibrated p 1e-10 ✓
131.5 EB05 122.2 · IC025 +6.7
3/3 methods agree
Not in label — unassessedserious n=509 · ♀ 100% (drug 63%) · 96% cliniciannot reported in cached trials
Gastrointestinal mucosal necrosis55192.2
137.1–269.4ROR 192.4 · calibrated p 2e-9 ✓
113.6 EB05 90.5 · IC025 +5.4
3/3 methods agree
Not in label — unassessedserious n=55 · ♀ 0% (drug 63%) · 100% cliniciannot reported in cached trials
Swollen joint count increased1,014149.3
138.5–160.9ROR 151.6 · calibrated p 4e-9 ✓
100.3 EB05 95.2 · IC025 +6.5
3/3 methods agree
Lab value / disease markerserious n=1,014 · ♀ 100% (drug 63%) · 96% cliniciannot reported in cached trials
Abortion incomplete553128.4
116.2–141.7ROR 129.4 · calibrated p 2e-8 ✓
90.3 EB05 84.1 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious n=203 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Adjustment disorder with depressed mood510104.8
94.8–115.8ROR 105.6 · calibrated p 8e-8 ✓
78.0 EB05 72.4 · IC025 +6.0
3/3 methods agree
Not in label — unassessedserious n=508 · ♀ 100% (drug 63%) · 95% cliniciannot reported in cached trials
Rheumatic fever1,095103.5
96.7–110.8ROR 105.2 · calibrated p 8e-8 ✓
77.4 EB05 73.6 · IC025 +6.1
3/3 methods agree
Not in label — unassessedserious n=1,095 · ♀ 100% (drug 63%) · 96% cliniciannot reported in cached trials
Retinitis409100.4
89.8–112.2ROR 101.0 · calibrated p 1e-7 ✓
75.4 EB05 69.5 · IC025 +6.0
3/3 methods agree
Not in label — unassessedserious n=409 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Facet joint syndrome71089.9
82.7–97.7ROR 90.8 · calibrated p 2e-7 ✓
69.5 EB05 65.3 · IC025 +5.9
3/3 methods agree
Not in label — unassessedserious n=710 · ♀ 100% (drug 63%) · 95% cliniciannot reported in cached trials
X-ray abnormal37381.6
72.8–91.5ROR 82.1 · calibrated p 5e-7 ✓
64.4 EB05 59.1 · IC025 +5.7
3/3 methods agree
Lab value / disease markerserious n=373 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Rheumatoid factor positive1,18379.7
74.8–85.0ROR 81.1 · calibrated p 5e-7 ✓
63.3 EB05 60.3 · IC025 +5.9
3/3 methods agree
Lab value / disease markerserious n=1,183 · ♀ 100% (drug 63%) · 95% cliniciannot reported in cached trials
Dislocation of vertebra45679.7
71.9–88.3ROR 80.2 · calibrated p 6e-7 ✓
63.2 EB05 58.5 · IC025 +5.7
3/3 methods agree
Not in label — unassessedserious n=456 · ♀ 100% (drug 63%) · 93% cliniciannot reported in cached trials
Overlap syndrome12266.4
54.6–80.7ROR 66.5 · calibrated p 3e-6 ✓
54.2 EB05 46.6 · IC025 +5.2
3/3 methods agree
Not in label — unassessedserious n=122 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Duodenal ulcer perforation1,21961.5
57.9–65.4ROR 62.6 · calibrated p 3e-6 ✓
51.3 EB05 48.9 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious PRR 40.8 · ♀ 100% (drug 63%) · 96% cliniciannot reported in cached trials
C-reactive protein abnormal93052.4
48.9–56.2ROR 53.1 · calibrated p 9e-6 ✓
44.8 EB05 42.5 · IC025 +5.3
3/3 methods agree
Lab value / disease markerserious n=928 · ♀ 100% (drug 63%) · 95% cliniciannot reported in cached trials
Bone erosion51051.9
47.3–57.0ROR 52.3 · calibrated p 1e-5 ✓
44.4 EB05 41.3 · IC025 +5.3
3/3 methods agree
Not in label — unassessedserious n=510 · ♀ 100% (drug 63%) · 97% cliniciannot reported in cached trials
Seronegative arthritis16051.3
43.4–60.7ROR 51.4 · calibrated p 1e-5 ✓
43.8 EB05 38.4 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=160 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Anti-cyclic citrullinated peptide antibody positive91945.8
42.8–49.1ROR 46.5 · calibrated p 2e-5 ✓
39.9 EB05 37.8 · IC025 +5.2
3/3 methods agree
Lab value / disease markerserious PRR 31.9 · ♀ 100% (drug 63%) · 95% cliniciannot reported in cached trials
Helicobacter infection1,28144.4
41.9–47.0ROR 45.2 · calibrated p 3e-5 ✓
38.8 EB05 37.1 · IC025 +5.2
3/3 methods agree
Not in label — unassessedserious PRR 32.4 · ♀ 100% (drug 63%) · 95% cliniciannot reported in cached trials
Porphyria acute17243.9
37.4–51.5ROR 44.0 · calibrated p 3e-5 ✓
38.3 EB05 33.8 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious n=172 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Folliculitis1,20040.6
38.2–43.1ROR 41.3 · calibrated p 4e-5 ✓
35.9 EB05 34.2 · IC025 +5.1
3/3 methods agree
Not in label — unassessedserious PRR 33.3 · ♀ 97% (drug 63%) · 95% cliniciannot reported in cached trials
Chronic kidney disease-mineral and bone disorder12038.7
32.0–46.8ROR 38.8 · calibrated p 7e-5 ✓
34.3 EB05 29.4 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious n=120not reported in cached trials
Muscle injury87236.7
34.2–39.3ROR 37.1 · calibrated p 8e-5 ✓
32.8 EB05 31.0 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious PRR 28.2 · ♀ 100% (drug 63%) · 95% cliniciannot reported in cached trials
Peripheral venous disease40234.5
31.2–38.3ROR 34.7 · calibrated p 1e-4 ✓
31.1 EB05 28.6 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=400 · ♀ 100% (drug 63%) · 92% cliniciannot reported in cached trials
Hand deformity1,27133.2
31.3–35.2ROR 33.8 · calibrated p 1e-4 ✓
30.0 EB05 28.7 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious PRR 25.9 · ♀ 100% (drug 63%) · 96% cliniciannot reported in cached trials
Subcutaneous drug absorption impaired5031.2
23.3–41.7ROR 31.2 · calibrated p 3e-4 ✓
28.1 EB05 22.1 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=48 · ♀ 100% (drug 63%) · 100% cliniciannot reported in cached trials
Hyperparathyroidism secondary22429.9
26.1–34.3ROR 30.0 · calibrated p 3e-4 ✓
27.3 EB05 24.4 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious n=224not reported in cached trials
Lip dry79229.9
27.8–32.2ROR 30.2 · calibrated p 3e-4 ✓
27.3 EB05 25.7 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious n=770 · ♀ 100% (drug 63%) · 94% cliniciannot reported in cached trials
Nephrogenic anaemia40529.3
26.4–32.4ROR 29.4 · calibrated p 3e-4 ✓
26.7 EB05 24.6 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious n=405not reported in cached trials
Drug tolerance decreased24129.0
25.5–33.1ROR 29.1 · calibrated p 3e-4 ✓
26.5 EB05 23.9 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious n=238 · ♀ 100% (drug 63%) · 90% cliniciannot reported in cached trials
Rebound acid hypersecretion26328.9
25.5–32.8ROR 29.0 · calibrated p 3e-4 ✓
26.5 EB05 23.9 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious n=263 · 100% consumernot reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

ConceptReportsPRR 95% CIReading
Interstitial lung disease1,0283.33.1–3.5signal
Liver injury3,0053.13.0–3.2signal
Severe cutaneous reaction7343.12.9–3.3signal
Pancreatitis7843.02.8–3.2signal
Kidney injury4,0402.82.7–2.8signal
Serious infection6,1702.52.4–2.5signal
Tendon disorder3042.52.2–2.8signal
Depression2,0472.32.2–2.4signal
Arrhythmia / qt1,1561.81.7–2.0raised
Anaemia1,7131.81.7–1.9raised
Hyperglycaemia / diabetes1,9441.71.7–1.8raised
Thrombocytopenia1,1891.71.6–1.8raised
Gi bleeding9391.61.5–1.7raised
Venous thromboembolism1,1001.61.5–1.7raised
Hyponatraemia3931.51.4–1.7raised
Opportunistic infection6281.41.3–1.5raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Doxycycline as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Drug ineffective (drug did not work)5,3361.3
1.2–1.3ROR 1.3 · calibrated p 0.491
1.3 EB05 1.2 · IC025 +0.3Reporting / coding artifactage-adj. PRR 1.5 · serious PRR 2.1not reported in cached trials
Nausea5,0392.0
1.9–2.0ROR 2.1 · calibrated p 0.976
2.0 EB05 1.9 · IC025 +0.9Labeled adverse reaction
exact term
age-adj. PRR 1.7 · serious PRR 2.3NCT01320033: 14/223 (6.3%) on Doxycycline; 4/222 (1.8%) control
Off label use (used outside approved label)4,8031.7
1.7–1.8ROR 1.8 · calibrated p 0.811
1.7 EB05 1.7 · IC025 +0.7Reporting / coding artifactage-adj. PRR 1.7 · serious PRR 2.0not reported in cached trials
Fatigue (tiredness)4,7241.9
1.8–1.9ROR 2.0 · calibrated p 0.917
1.9 EB05 1.8 · IC025 +0.9Not in label — unassessedage-adj. PRR 1.7 · serious PRR 2.2not reported in cached trials
Rash4,1863.0
2.9–3.1ROR 3.1 · calibrated p 0.584
3.0 EB05 2.9 · IC025 +1.5
3/3 methods agree
Labeled adverse reaction
exact term
age-adj. PRR 3.0 · serious PRR 4.0not reported in cached trials
Diarrhoea (diarrhea)4,0652.0
1.9–2.0ROR 2.0 · calibrated p 0.955
2.0 EB05 1.9 · IC025 +0.9Labeled adverse reaction
exact term
age-adj. PRR 1.7 · serious PRR 2.1not reported in cached trials
Dyspnoea (shortness of breath)4,0532.2
2.2–2.3ROR 2.3 · calibrated p 0.902
2.2 EB05 2.2 · IC025 +1.1
3/3 methods agree
Not in label — unassessedage-adj. PRR 2.0 · serious PRR 2.2not reported in cached trials
Pain4,0212.0
2.0–2.1ROR 2.1 · calibrated p 0.993
2.0 EB05 2.0 · IC025 +1.0Labeled adverse reaction
exact term
age-adj. PRR 2.1 · serious PRR 2.1not reported in cached trials
Headache3,9532.0
1.9–2.0ROR 2.0 · calibrated p 0.953
2.0 EB05 1.9 · IC025 +0.9Labeled adverse reaction
exact term
age-adj. PRR 1.7 · serious PRR 2.5NCT01320033: 15/223 (6.7%) on Doxycycline; 6/222 (2.7%) control
Vomiting3,8592.6
2.5–2.6ROR 2.7 · calibrated p 0.751
2.5 EB05 2.5 · IC025 +1.3
3/3 methods agree
Labeled adverse reaction
exact term
age-adj. PRR 2.3 · serious PRR 2.6 · ♀ 83% (drug 63%)NCT01320033: 15/223 (6.7%) on Doxycycline; 5/222 (2.3%) control
Malaise (feeling unwell)3,0082.1
2.1–2.2ROR 2.2 · calibrated p 0.964
2.1 EB05 2.1 · IC025 +1.0
3/3 methods agree
Labeled adverse reaction
exact term
age-adj. PRR 2.1 · serious PRR 2.5not reported in cached trials
Condition aggravated2,9703.1
3.0–3.2ROR 3.2 · calibrated p 0.578
3.0 EB05 2.9 · IC025 +1.5
3/3 methods agree
Reporting / coding artifactage-adj. PRR 2.7 · serious PRR 3.2not reported in cached trials
Dizziness2,9451.8
1.8–1.9ROR 1.9 · calibrated p 0.872
1.8 EB05 1.8 · IC025 +0.8Not in label — unassessedage-adj. PRR 1.7 · serious PRR 2.1not reported in cached trials
Pruritus (itching)2,9372.4
2.3–2.5ROR 2.5 · calibrated p 0.823
2.4 EB05 2.3 · IC025 +1.2
3/3 methods agree
Not in label — unassessedage-adj. PRR 2.2 · serious PRR 3.5not reported in cached trials

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.

✓ 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 nausea, fatigue, rash, diarrhoea, dyspnoea, pain. 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

Page generated 2026-10-14. 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.