What the label lists and what reports show
Doxycycline side effects
Doxycycline's FDA label lists its adverse reactions in its own words. FAERS holds 69,571 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 (5,167 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the doxycycline FDA label on DailyMed (effective July 25, 2025, Chartwell RX, LLC.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsDue to oral doxycycline’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. Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis. Hepatotoxicity has been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline class. Most of these patients took medications immediately before going to bed ( see DOSAGE AND ADMINISTRATION ). …
Table 1. Incidence (%) of Selected Adverse Reactions in Clinical Trials of ORACEA (n=269) v.s. Placebo (n=268)
This table is printed in the ORACEA label published by Galderma Laboratories, L.P. of April 16, 2025; the label quoted above does not print one.
| Reaction | ORACEA | Placebo |
|---|---|---|
| Nasopharyngitis | 13 (5) | 9 (3) |
| Pharyngolaryngeal Pain | 3 (1) | 2 (1) |
| Sinusitis | 7 (3) | 2 (1) |
| Nasal Congestion | 4 (2) | 2 (1) |
| Fungal Infection | 5 (2) | 1 (0) |
| Influenza | 5 (2) | 3 (1) |
| Diarrhea | 12 (5) | 7 (3) |
| Abdominal Pain Upper | 5 (2) | 1 (0) |
| Abdominal Distention | 3 (1) | 1 (0) |
| Abdominal Pain | 3 (1) | 1 (0) |
| Stomach Discomfort | 3 (1) | 2 (1) |
| Dry Mouth | 3 (1) | 0 (0) |
| Hypertension | 8 (3) | 2 (1) |
| Blood Pressure Increase | 4 (2) | 1 (0) |
| Aspartate Aminotransferase Increase | 6 (2) | 2 (1) |
| Blood Lactate Dehydrogenase Increase | 4 (2) | 1 (0) |
| Blood Glucose Increase | 3 (1) | 0 (0) |
| Anxiety | 4 (2) | 0 (0) |
| Pain | 4 (2) | 1 (0) |
| Back Pain | 3 (1) | 0 (0) |
| Sinus Headache | 3 (1) | 0 (0) |
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, Chartwell RX, LLC., effective July 25, 2025 (SPL set 02aa8731-d40f-43d8-8b63-a79a0503f8db), via openFDA; the full label on DailyMed
What do FAERS reports show?
69,571 reports list doxycycline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,819 are coded as a death and 22,202 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, 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?
- Doxycycline: 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