What the label lists and what reports show
Minocycline side effects
Minocycline's FDA label lists its adverse reactions in its own words. FAERS holds 16,577 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (1,657 reports).
- Generic listed
Check it at the source: the minocycline FDA label on DailyMed (effective April 2, 2026, Torrent Pharmaceuticals Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of EMROSI?EMROSI may cause serious side effects, including: Serious skin and allergic reactions have happened during treatment with minocycline. EMROSI may cause serious skin or allergic reactions that may also affect parts of your body such as your liver, lungs, kidneys, and heart. Sometimes these reactions can lead to death. […]
Source: FDA drug label (EMROSI), Journey Medical Corporation, effective April 22, 2025 (SPL set 0899eb25-8807-037c-f66c-141a2696b1c0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsDue to oral minocycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Body as a whole: Fever and discoloration of secretions. Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions. Instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ). Genitourinary: Vulvovaginitis. …
Table 5: Adverse Events (AEs) Reported in ≥3% of the Combined Clinical Trial Population of 3 Multicenter US Trials by Treatment Group
This table is printed in the Arestin label published by OraPharma, Inc. of May 31, 2024; the label quoted above does not print one.
| Reaction | SRP Alone N=250 | SRP + Vehicle N=249 | SRP + ARESTIN ® N=423 |
|---|---|---|---|
| Number (%) of Subjects Treatment-emergent AEs | 62.4% | 71.9% | 68.1% |
| Total Number of AEs | 543 | 589 | 987 |
| Periodontitis | 25.6% | 28.1% | 16.3% |
| Tooth Disorder | 12.0% | 13.7% | 12.3% |
| Tooth Caries | 9.2% | 11.2% | 9.9% |
| Dental Pain | 8.8% | 8.8% | 9.9% |
| Gingivitis | 7.2% | 8.8% | 9.2% |
| Headache | 7.2% | 11.6% | 9.0% |
| Infection | 8.0% | 9.6% | 7.6% |
| Stomatitis | 8.4% | 6.8% | 6.4% |
| Mouth Ulceration | 1.6% | 3.2% | 5.0% |
| Flu Syndrome | 3.2% | 6.4% | 5.0% |
| Pharyngitis | 3.2% | 1.6% | 4.3% |
| Pain | 4.0% | 1.2% | 4.3% |
| Dyspepsia | 2.0% | 0 | 4.0% |
| Infection Dental | 4.0% | 3.6% | 3.8% |
| Mucous Membrane Disorder | 2.4% | 0.8% | 3.3% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Torrent Pharmaceuticals Limited, effective April 2, 2026 (SPL set 55df55fb-18ec-4e00-9ed0-10bba0da513b), via openFDA; the full label on DailyMed
What do FAERS reports show?
16,577 reports list minocycline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,817 are coded as a death and 5,716 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Minocycline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions