Doxycycline side effects: what 67,795 FDA adverse event reports show
Drug class
Tetracycline-class Drug
Who reports
67,795 reports · 72% serious · 6,693 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 40 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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, 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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Amyloid arthropathy | 55 | 1,858.1 918.3–3,759.4ROR 1,859.6 · calibrated p 6e-17 ✓ | 240.3 EB05 191.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Grip strength | 142 | 496.3 380.1–648.0ROR 497.3 · calibrated p 2e-13 ✓ | 184.5 EB05 160.4 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=142 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Congenital hiatus hernia | 119 | 361.8 277.4–472.0ROR 362.5 · calibrated p 3e-12 ✓ | 161.5 EB05 138.6 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=119 · ♀ 0% (drug 63%) | not reported in cached trials |
| C-reactive protein | 462 | 323.7 284.0–368.9ROR 325.9 · calibrated p 5e-12 ✓ | 156.3 EB05 144.7 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=462 · ♀ 100% (drug 63%) · 97% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 869 | 247.6 226.5–270.7ROR 250.8 · calibrated p 5e-11 ✓ | 136.5 EB05 129.1 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=869 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 295 | 246.4 211.4–287.3ROR 247.5 · calibrated p 7e-11 ✓ | 135.4 EB05 122.9 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=295 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Jarisch-herxheimer reaction | 309 | 237.3 204.5–275.3ROR 238.3 · calibrated p 1e-10 ✓ | 132.6 EB05 120.7 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=294 · ♀ 28% (drug 63%) · 100% clinician | not reported in cached trials |
| Swollen joint count | 106 | 235.2 182.6–303.1ROR 235.6 · calibrated p 2e-10 ✓ | 130.0 EB05 110.5 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=106 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Lupus vulgaris | 509 | 232.4 207.1–260.7ROR 234.1 · calibrated p 1e-10 ✓ | 131.5 EB05 122.2 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=509 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Gastrointestinal mucosal necrosis | 55 | 192.2 137.1–269.4ROR 192.4 · calibrated p 2e-9 ✓ | 113.6 EB05 90.5 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Swollen joint count increased | 1,014 | 149.3 138.5–160.9ROR 151.6 · calibrated p 4e-9 ✓ | 100.3 EB05 95.2 · IC025 +6.5 3/3 methods agree | Lab value / disease marker | serious n=1,014 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Abortion incomplete | 553 | 128.4 116.2–141.7ROR 129.4 · calibrated p 2e-8 ✓ | 90.3 EB05 84.1 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=203 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 510 | 104.8 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 — unassessed | serious n=508 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Rheumatic fever | 1,095 | 103.5 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 — unassessed | serious n=1,095 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Retinitis | 409 | 100.4 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 — unassessed | serious n=409 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 710 | 89.9 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 — unassessed | serious n=710 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| X-ray abnormal | 373 | 81.6 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 marker | serious n=373 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,183 | 79.7 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 marker | serious n=1,183 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Dislocation of vertebra | 456 | 79.7 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 — unassessed | serious n=456 · ♀ 100% (drug 63%) · 93% clinician | not reported in cached trials |
| Overlap syndrome | 122 | 66.4 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 — unassessed | serious n=122 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 1,219 | 61.5 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 — unassessed | serious PRR 40.8 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| C-reactive protein abnormal | 930 | 52.4 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 marker | serious n=928 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Bone erosion | 510 | 51.9 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 — unassessed | serious n=510 · ♀ 100% (drug 63%) · 97% clinician | not reported in cached trials |
| Seronegative arthritis | 160 | 51.3 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 — unassessed | serious n=160 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 892 | 49.6 46.3–53.3ROR 50.3 · calibrated p 1e-5 ✓ | 42.8 EB05 40.5 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=890 · ♀ 100% (drug 63%) · 97% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 919 | 45.8 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 marker | serious PRR 31.9 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Helicobacter infection | 1,281 | 44.4 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 — unassessed | serious PRR 32.4 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Porphyria acute | 172 | 43.9 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 — unassessed | serious n=172 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Folliculitis | 1,200 | 40.6 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 — unassessed | serious PRR 33.3 · ♀ 97% (drug 63%) · 95% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 120 | 38.7 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 — unassessed | serious n=120 | not reported in cached trials |
| Muscle injury | 872 | 36.7 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 — unassessed | serious PRR 28.2 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Peripheral venous disease | 402 | 34.5 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 — unassessed | serious n=400 · ♀ 100% (drug 63%) · 92% clinician | not reported in cached trials |
| Hand deformity | 1,271 | 33.2 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 — unassessed | serious PRR 25.9 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Autoimmune disorder | 890 | 31.6 29.5–33.9ROR 32.0 · calibrated p 2e-4 ✓ | 28.7 EB05 27.2 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.4 · ♀ 98% (drug 63%) · 93% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 50 | 31.2 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 — unassessed | serious n=48 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Hyperparathyroidism secondary | 224 | 29.9 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 — unassessed | serious n=224 | not reported in cached trials |
| Lip dry | 792 | 29.9 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 — unassessed | serious n=770 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Nephrogenic anaemia | 405 | 29.3 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 — unassessed | serious n=405 | not reported in cached trials |
| Drug tolerance decreased | 241 | 29.0 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 — unassessed | serious n=238 · ♀ 100% (drug 63%) · 90% clinician | not reported in cached trials |
| Rebound acid hypersecretion | 263 | 28.9 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 — unassessed | serious n=263 · 100% consumer | not 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.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Interstitial lung disease | 1,028 | 3.33.1–3.5 | signal |
| Liver injury | 3,005 | 3.13.0–3.2 | signal |
| Severe cutaneous reaction | 734 | 3.12.9–3.3 | signal |
| Pancreatitis | 784 | 3.02.8–3.2 | signal |
| Kidney injury | 4,040 | 2.82.7–2.8 | signal |
| Serious infection | 6,170 | 2.52.4–2.5 | signal |
| Tendon disorder | 304 | 2.52.2–2.8 | signal |
| Depression | 2,047 | 2.32.2–2.4 | signal |
| Arrhythmia / qt | 1,156 | 1.81.7–2.0 | raised |
| Anaemia | 1,713 | 1.81.7–1.9 | raised |
| Hyperglycaemia / diabetes | 1,944 | 1.71.7–1.8 | raised |
| Thrombocytopenia | 1,189 | 1.71.6–1.8 | raised |
| Gi bleeding | 939 | 1.61.5–1.7 | raised |
| Venous thromboembolism | 1,100 | 1.61.5–1.7 | raised |
| Hyponatraemia | 393 | 1.51.4–1.7 | raised |
| Opportunistic infection | 628 | 1.41.3–1.5 | raised |
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).
- NCT01320033 — Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Ca (N=662, PHASE2; 15 AE terms posted; arms: CD2475/101 40 mg; Doxycycline 100 mg; Placebo)
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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 5,336 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.491 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | age-adj. PRR 1.5 · serious PRR 2.1 | not reported in cached trials |
| Nausea | 5,039 | 2.0 1.9–2.0ROR 2.1 · calibrated p 0.976 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.3 | NCT01320033: 14/223 (6.3%) on Doxycycline; 4/222 (1.8%) control |
| Off label use (used outside approved label) | 4,803 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.811 | 1.7 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | age-adj. PRR 1.7 · serious PRR 2.0 | not reported in cached trials |
| Fatigue (tiredness) | 4,724 | 1.9 1.8–1.9ROR 2.0 · calibrated p 0.917 | 1.9 EB05 1.8 · IC025 +0.9 | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 2.2 | not reported in cached trials |
| Rash | 4,186 | 3.0 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 4.0 | not reported in cached trials |
| Diarrhoea (diarrhea) | 4,065 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.955 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.1 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 4,053 | 2.2 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 — unassessed | age-adj. PRR 2.0 · serious PRR 2.2 | not reported in cached trials |
| Pain | 4,021 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.993 | 2.0 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 2.1 | not reported in cached trials |
| Headache | 3,953 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.953 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.5 | NCT01320033: 15/223 (6.7%) on Doxycycline; 6/222 (2.7%) control |
| Vomiting | 3,859 | 2.6 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 |
| Drug hypersensitivity | 3,745 | 6.1 5.9–6.3ROR 6.4 · calibrated p 0.129 | 6.0 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 5.8 · serious PRR 6.3 · ♀ 87% (drug 63%) | not reported in cached trials |
| Malaise (feeling unwell) | 3,008 | 2.1 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 2.5 | not reported in cached trials |
| Condition aggravated | 2,970 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.578 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 2.7 · serious PRR 3.2 | not reported in cached trials |
| Dizziness | 2,945 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.872 | 1.8 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 2.1 | not reported in cached trials |
| Pruritus (itching) | 2,937 | 2.4 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 — unassessed | age-adj. PRR 2.2 · serious PRR 3.5 | not 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.
- Amyloid arthropathy — n=55, PRR 1,858.1
- Grip strength — n=142, PRR 496.3
- Congenital hiatus hernia — n=119, PRR 361.8
- Deep vein thrombosis postoperative — n=869, PRR 247.6
- Jarisch-herxheimer reaction — n=309, PRR 237.3
- Swollen joint count — n=106, PRR 235.2
- Lupus vulgaris — n=509, PRR 232.4
- Gastrointestinal mucosal necrosis — n=55, PRR 192.2
- Abortion incomplete — n=553, PRR 128.4
- Adjustment disorder with depressed mood — n=510, PRR 104.8
✓ 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
- FDA label via openFDA (set ID 0e6b3e17-aeee-4910-8e94-c7ac925b9cca, effective 20250415; matched on
openfda.generic_name.exact:"DOXYCYCLINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,201 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 - ClinicalTrials.gov API v2 (query
DOXYCYCLINE, results-bearing studies sorted by enrollment)
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.