What the label lists and what reports show
Demeclocycline side effects
Demeclocycline's FDA label lists its adverse reactions in its own words. FAERS holds 228 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 hyponatraemia (41 reports).
- Generic listed
Check it at the source: the demeclocycline FDA label on DailyMed (effective April 2, 2026, Amneal Pharmaceuticals of New York LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following reactions have been reported in patients receiving tetracyclines: Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitis and inflammatory lesions (with monilial overgrowth) in the anogenital region, increases in liver enzymes, and hepatic toxicity has been reported rarely. Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Instances of esophageal ulcerations have been reported in patients receiving oral tetracyclines. Most of the patients were reported to have taken the medication immediately before lying down (see DOSAGE AND ADMINISTRATION ). Skin: Maculopapular and erythematous rashes, erythema multiforme. Exfoliative dermatitis has been reported but is uncommon. …
Source: FDA drug label, Amneal Pharmaceuticals of New York LLC, effective April 2, 2026 (SPL set 539add06-e0a0-401a-b4f6-20776084aa9c), via openFDA; the full label on DailyMed
What do FAERS reports show?
228 reports list demeclocycline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 39 are coded as a death and 131 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 22 reactions below, 4 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.
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?
- Demeclocycline: 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