What the label lists and what reports show
Sarecycline side effects
Sarecycline's FDA label: “Most common adverse reaction (incidence ≥ 1%) is nausea.” FAERS holds 191 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 headache (21 reports).
- No generic listed
Check it at the source: the sarecycline FDA label on DailyMed (effective June 5, 2024, Almirall, LLC); 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 SEYSARA?SEYSARA may cause serious side effects, including: Harm to an unborn baby. See “ What should I tell my healthcare provider before taking SEYSARA? ” Permanent teeth discoloration. SEYSARA may permanently turn a baby or child's teeth yellow-gray-brown during tooth development. You should not use SEYSARA during tooth development. Tooth development happens in the second and third trimesters of pregnancy, and from birth to 8 years of age. Slow bone growth. SEYSARA may slow bone growth in infants and children. Slow bone growth is reversible after stopping treatment with SEYSARA. Diarrhea. Diarrhea can happen with most antibiotics, including SEYSARA. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your healthcare provider right away if you get watery or bloody stools. Central nervous system effects. […]
Source: FDA drug label, Almirall, LLC, effective June 5, 2024 (SPL set b200957c-3004-4988-be97-9fd619a83649), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reaction (incidence ≥ 1%) is nausea.
From the label: adverse reactions, continuedMost common adverse reaction (incidence ≥ 1%) is nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almirall at 1-866-665-2782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 1064 subjects and 1069 subjects with moderate to severe acne vulgaris were treated with SEYSARA and placebo, respectively, for 12 weeks in 3 controlled clinical trials. The only adverse drug reaction that was reported in at least 1% of subjects was nausea, SEYSARA (3.1%) versus placebo (2.0%). The following additional adverse drug reactions occurred in less than 1% of female SEYSARA subjects: vulvovaginal mycotic infection (0.8%) and vulvovaginal candidiasis (0.6%).
Source: FDA drug label, Almirall, LLC, effective June 5, 2024 (SPL set b200957c-3004-4988-be97-9fd619a83649), via openFDA; the full label on DailyMed
What do FAERS reports show?
191 reports list sarecycline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 15 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 20 reactions below, 2 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?
- Sarecycline: 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