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Minocycline Hydrochloride side effects: what 5,790 FDA adverse event reports show

Minocycline Hydrochloride · Zilxi · 411 reaction terms · 69,023 drug–reaction co-reports · data 2026-09-14
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Drug class

Tetracycline-class drug

FDA label, Indications wording

Brand names

Zilxi

openFDA label

Who reports

5,790 reports · 81% serious · 1,708 with death outcome · 70% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults . Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of dru.

FDA label, Indications and Usage

What it is

Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S‑(4α,4aα,5aα,12aα)]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a‑tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride.

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 adverse reaction 3Labeled (related wording) 4Reporting / coding artifact 4Lab value / disease marker 3Not in label — unassessed 26
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 371 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
Pemphigus629193.0
178.8–208.2ROR 216.3 · χ² 113,841 / p <1e-300
182.1 EB05 170.5 · IC025 +7.2
3/3 methods agree
Not in label — unassessedserious PRR 129.9 · ♀ 100% (drug 70%) · 93% cliniciannot reported in cached trials
Folliculitis435159.2
145.1–174.6ROR 172.0 · χ² 65,331 / p <1e-300
151.4 EB05 139.8 · IC025 +6.9
3/3 methods agree
Not in label — unassessedserious PRR 126.7 · ♀ 98% (drug 70%) · 90% cliniciannot reported in cached trials
Helicobacter infection419155.2
141.2–170.5ROR 167.2 · χ² 61,388 / p <1e-300
147.8 EB05 136.3 · IC025 +6.8
3/3 methods agree
Not in label — unassessedserious PRR 111.2 · ♀ 100% (drug 70%) · 92% cliniciannot reported in cached trials
Hypercholesterolaemia386152.2
137.9–168.0ROR 163.0 · χ² 55,487 / p <1e-300
145.0 EB05 133.2 · IC025 +6.8
3/3 methods agree
Not in label — unassessedserious PRR 109.8 · ♀ 99% (drug 70%)not reported in cached trials
Pericarditis646146.0
135.5–157.3ROR 164.2 · χ² 89,303 / p <1e-300
139.7 EB05 130.9 · IC025 +6.9
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 99.9 · ♀ 100% (drug 70%) · 93% cliniciannot reported in cached trials
Hand deformity497142.9
131.2–155.8ROR 156.3 · χ² 67,262 / p <1e-300
136.8 EB05 127.0 · IC025 +6.8
3/3 methods agree
Not in label — unassessedserious PRR 105.8 · ♀ 100% (drug 70%) · 92% cliniciannot reported in cached trials
Synovitis629130.7
121.2–140.9ROR 146.5 · χ² 78,053 / p <1e-300
125.7 EB05 117.6 · IC025 +6.7
3/3 methods agree
Not in label — unassessedserious PRR 93.3 · ♀ 100% (drug 70%) · 93% cliniciannot reported in cached trials
Red blood cell sedimentation rate increased386130.5
118.3–144.0ROR 139.8 · χ² 47,767 / p <1e-300
125.2 EB05 115.1 · IC025 +6.6
3/3 methods agree
Lab value / disease markerserious PRR 100.8 · 92% cliniciannot reported in cached trials
Bursitis353109.1
98.4–120.9ROR 116.1 · χ² 36,603 / p <1e-300
105.3 EB05 96.4 · IC025 +6.4
3/3 methods agree
Not in label — unassessedserious PRR 88.2 · ♀ 100% (drug 70%) · 90% cliniciannot reported in cached trials
Back injury293100.7
89.9–112.7ROR 106.0 · χ² 28,039 / p <1e-300
97.3 EB05 88.3 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious PRR 91.4 · ♀ 100% (drug 70%)not reported in cached trials
Wound infection28597.5
86.9–109.3ROR 102.5 · χ² 26,408 / p <1e-300
94.3 EB05 85.5 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious PRR 72.0 · ♀ 100% (drug 70%) · 91% cliniciannot reported in cached trials
Joint dislocation26091.6
81.2–103.4ROR 95.9 · χ² 22,648 / p <1e-300
88.8 EB05 80.1 · IC025 +6.1
3/3 methods agree
Not in label — unassessedserious PRR 71.2 · ♀ 100% (drug 70%)not reported in cached trials
Glossodynia (burning tongue/mouth pain)54590.4
83.4–98.1ROR 99.7 · χ² 46,979 / p <1e-300
88.0 EB05 81.9 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious PRR 90.1 · ♀ 100% (drug 70%) · 90% cliniciannot reported in cached trials
Coeliac disease23990.3
79.6–102.4ROR 94.2 · χ² 20,514 / p <1e-300
87.5 EB05 78.6 · IC025 +6.0
3/3 methods agree
Not in label — unassessedserious PRR 77.6 · ♀ 100% (drug 70%)not reported in cached trials
Foot deformity26789.2
79.2–100.5ROR 93.5 · χ² 22,650 / p <1e-300
86.6 EB05 78.2 · IC025 +6.0
3/3 methods agree
Not in label — unassessedserious PRR 71.6 · ♀ 100% (drug 70%)not reported in cached trials
Wound65687.5
81.3–94.1ROR 98.5 · χ² 54,720 / p <1e-300
85.2 EB05 79.9 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious PRR 71.9 · ♀ 100% (drug 70%) · 91% cliniciannot reported in cached trials
Joint range of motion decreased29982.8
74.1–92.6ROR 87.3 · χ² 23,555 / p <1e-300
80.6 EB05 73.2 · IC025 +6.0
3/3 methods agree
Not in label — unassessedserious PRR 73.0 · ♀ 100% (drug 70%)not reported in cached trials
Contraindicated product administered66581.6
75.9–87.7ROR 92.0 · χ² 51,753 / p <1e-300
79.6 EB05 74.7 · IC025 +6.1
3/3 methods agree
Reporting / coding artifactserious PRR 70.2 · 91% cliniciannot reported in cached trials
Laryngitis21773.8
64.7–84.2ROR 76.6 · χ² 15,208 / p <1e-300
71.9 EB05 64.2 · IC025 +5.7
3/3 methods agree
Not in label — unassessedserious n=215 · ♀ 100% (drug 70%) · 96% cliniciannot reported in cached trials
C-reactive protein increased67868.8
64.0–73.9ROR 77.7 · χ² 44,427 / p <1e-300
67.4 EB05 63.2 · IC025 +5.9
3/3 methods agree
Lab value / disease markerserious PRR 49.7 · 94% cliniciannot reported in cached trials
Fibromyalgia44066.8
61.0–73.1ROR 72.2 · χ² 27,954 / p <1e-300
65.4 EB05 60.4 · IC025 +5.8
3/3 methods agree
Not in label — unassessedserious PRR 60.9 · ♀ 100% (drug 70%)not reported in cached trials
Adverse reaction23966.4
58.6–75.3ROR 69.2 · χ² 15,058 / p <1e-300
64.9 EB05 58.3 · IC025 +5.6
3/3 methods agree
Reporting / coding artifactserious n=239 · ♀ 99% (drug 70%)not reported in cached trials
Type 2 diabetes mellitus56861.9
57.2–67.0ROR 68.5 · χ² 33,452 / p <1e-300
60.8 EB05 56.7 · IC025 +5.7
3/3 methods agree
Not in label — unassessedserious PRR 45.4 · ♀ 100% (drug 70%) · 92% cliniciannot reported in cached trials
Irritable bowel syndrome35160.4
54.6–67.0ROR 64.3 · χ² 20,141 / p <1e-300
59.3 EB05 54.3 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious PRR 53.4 · ♀ 96% (drug 70%) · 93% cliniciannot reported in cached trials
Liver injury38758.9
53.4–64.9ROR 63.0 · χ² 21,624 / p <1e-300
57.8 EB05 53.1 · IC025 +5.6
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 42.5 · ♀ 98% (drug 70%) · 91% cliniciannot reported in cached trials
Obesity25358.3
51.6–65.8ROR 60.9 · χ² 13,976 / p <1e-300
57.2 EB05 51.5 · IC025 +5.5
3/3 methods agree
Not in label — unassessedserious PRR 47.1 · ♀ 100% (drug 70%) · 90% cliniciannot reported in cached trials
Taste disorder27951.1
45.5–57.3ROR 53.6 · χ² 13,474 / p <1e-300
50.2 EB05 45.5 · IC025 +5.3
3/3 methods agree
Not in label — unassessedserious PRR 70.9 · ♀ 98% (drug 70%)not reported in cached trials
Psoriatic arthropathy55350.5
46.6–54.7ROR 55.7 · χ² 26,437 / p <1e-300
49.7 EB05 46.3 · IC025 +5.4
3/3 methods agree
Not in label — unassessedserious PRR 44.3 · ♀ 99% (drug 70%) · 91% cliniciannot reported in cached trials
Osteoarthritis56849.1
45.3–53.1ROR 54.3 · χ² 26,383 / p <1e-300
48.3 EB05 45.1 · IC025 +5.4
3/3 methods agree
Not in label — unassessedserious PRR 38.4 · ♀ 100% (drug 70%)not reported in cached trials
Hepatic cirrhosis24548.1
42.5–54.4ROR 50.2 · χ² 11,106 / p <1e-300
47.3 EB05 42.5 · IC025 +5.2
3/3 methods agree
Not in label — unassessedserious PRR 34.0 · ♀ 99% (drug 70%) · 96% cliniciannot reported in cached trials
Therapeutic product effect decreased53243.9
40.5–47.6ROR 48.2 · χ² 22,041 / p <1e-300
43.3 EB05 40.3 · IC025 +5.2
3/3 methods agree
Reporting / coding artifactserious PRR 60.6 · ♀ 99% (drug 70%) · 90% cliniciannot reported in cached trials
Gait inability36540.4
36.5–44.6ROR 43.0 · χ² 13,834 / p <1e-300
39.8 EB05 36.5 · IC025 +5.1
3/3 methods agree
Not in label — unassessedserious PRR 35.0 · ♀ 99% (drug 70%)not reported in cached trials
Blood cholesterol increased51040.0
36.8–43.5ROR 43.8 · χ² 19,188 / p <1e-300
39.5 EB05 36.7 · IC025 +5.1
3/3 methods agree
Lab value / disease markerserious PRR 42.5 · ♀ 98% (drug 70%) · 92% cliniciannot reported in cached trials
Hepatitis (liver inflammation)27839.7
35.4–44.6ROR 41.7 · χ² 10,357 / p <1e-300
39.2 EB05 35.5 · IC025 +5.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 28.3 · ♀ 98% (drug 70%)not reported in cached trials
Impaired healing35639.7
35.8–43.9ROR 42.2 · χ² 13,253 / p <1e-300
39.2 EB05 35.9 · IC025 +5.0
3/3 methods agree
Reporting / coding artifactserious PRR 33.6 · ♀ 99% (drug 70%)not reported in cached trials
Joint stiffness26937.5
33.3–42.1ROR 39.3 · χ² 9,428 / p <1e-300
37.0 EB05 33.4 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious PRR 47.4 · ♀ 99% (drug 70%)not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Minocycline 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)1,3103.6
3.4–3.8ROR 4.4 · χ² 2,625 / p <1e-300
3.6 EB05 3.4 · IC025 +1.8
3/3 methods agree
Reporting / coding artifactserious PRR 6.9not reported in cached trials
Off label use (used outside approved label)1,2035.0
4.8–5.3ROR 6.1 · χ² 4,034 / p <1e-300
5.0 EB05 4.8 · IC025 +2.2
3/3 methods agree
Reporting / coding artifactserious PRR 6.5 · ♀ 90% (drug 70%) · 90% cliniciannot reported in cached trials
Drug intolerance96936.8
34.7–39.0ROR 44.0 · χ² 33,529 / p <1e-300
36.4 EB05 34.5 · IC025 +5.1
3/3 methods agree
Reporting / coding artifactserious PRR 41.7not reported in cached trials
Pain9565.6
5.3–6.0ROR 6.5 · χ² 3,741 / p <1e-300
5.6 EB05 5.3 · IC025 +2.4
3/3 methods agree
Not in label — unassessedserious PRR 6.0NCT03142451: 1/256 (0.4%) on Minocycline (serious AE)
Rheumatoid arthritis92930.0
28.3–31.8ROR 35.5 · χ² 25,919 / p <1e-300
29.7 EB05 28.2 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious PRR 25.7 · ♀ 95% (drug 70%)not reported in cached trials
Nausea8443.9
3.6–4.1ROR 4.4 · χ² 1,866 / p <1e-300
3.9 EB05 3.7 · IC025 +1.8
3/3 methods agree
Not in label — unassessedserious PRR 4.9 · ♀ 93% (drug 70%)NCT03142451: 1/494 (0.2%) on Minocycline (serious AE)
Rash8176.8
6.4–7.3ROR 7.8 · χ² 4,139 / p <1e-300
6.8 EB05 6.4 · IC025 +2.6
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 10.1 · ♀ 93% (drug 70%)not reported in cached trials
Arthralgia (joint pain)8107.1
6.6–7.6ROR 8.1 · χ² 4,306 / p <1e-300
7.1 EB05 6.7 · IC025 +2.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 8.9 · ♀ 96% (drug 70%)not reported in cached trials
Fatigue (tiredness)7543.5
3.3–3.8ROR 3.9 · χ² 1,406 / p <1e-300
3.5 EB05 3.3 · IC025 +1.7
3/3 methods agree
Not in label — unassessedserious PRR 4.5 · ♀ 93% (drug 70%)NCT03142451: 1/494 (0.2%) on Minocycline (serious AE)
Joint swelling75022.7
21.2–24.2ROR 25.9 · χ² 15,506 / p <1e-300
22.5 EB05 21.2 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious PRR 27.2not reported in cached trials
Headache7064.1
3.8–4.4ROR 4.5 · χ² 1,690 / p <1e-300
4.1 EB05 3.8 · IC025 +1.9
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 5.4 · ♀ 93% (drug 70%)NCT04608500: 11/514 (2.1%) on Minocycline
Condition aggravated6998.4
7.8–9.0ROR 9.4 · χ² 4,603 / p <1e-300
8.3 EB05 7.8 · IC025 +2.9
3/3 methods agree
Reporting / coding artifactserious PRR 8.8 · ♀ 93% (drug 70%)not reported in cached trials
General physical health deterioration68921.8
20.4–23.4ROR 24.6 · χ² 13,669 / p <1e-300
21.7 EB05 20.4 · IC025 +4.3
3/3 methods agree
Reporting / coding artifactserious PRR 18.0 · ♀ 98% (drug 70%) · 92% cliniciannot 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: Minocycline ↔ Skin hyperpigmentation.

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 Minocycline?

In FDA FAERS, the most frequently co-reported reaction terms for Minocycline are pain, rheumatoid arthritis, nausea, rash, arthralgia, drug hypersensitivity. 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 Minocycline have an FDA boxed warning?

No. The FDA label retrieved for Minocycline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Minocycline 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 2026-10-08. 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.