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What the label lists and what reports show

Tetracycline side effects

Tetracycline's FDA label lists its adverse reactions in its own words. FAERS holds 767 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 drug hypersensitivity (152 reports).

  • Generic listed

Check it at the source: the tetracycline FDA label on DailyMed (effective March 18, 2025, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Gastrointestinal: anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with Candida overgrowth) in the anogenital region. Esophagitis and esophageal ulceration have been reported in patients receiving particularly the capsule and also the tablet forms of tetracyclines. Most of the patients were reported to have taken medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ). Teeth: permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has been reported (see WARNINGS ). Skin: fixed drug eruption, maculopapular and erythematous rashes. Exfoliative dermatitis has been reported. Onycholysis and discoloration of the nails have been reported. Photosensitivity is discussed in WARNINGS . …

Source: FDA drug label, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective March 18, 2025 (SPL set eaa5b1bd-0927-46e4-b941-32fcc492d258), via openFDA; the full label on DailyMed

What do FAERS reports show?

767 reports list tetracycline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 208 are coded as a death and 286 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 21 reactions below, 5 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

  • Off Label Use (a use or a product term, not a reaction)223
  • Drug Hypersensitivity152
  • Hypersensitivity (named in the label)125
  • Pneumonia (a use or a product term, not a reaction)105
  • Intentional Product Use Issue (a use or a product term, not a reaction)101
  • Pain In Extremity95
  • Vomiting (named in the label)93
  • Arthralgia (named in the label)91
  • Mobility Decreased91
  • Neck Pain90
  • Hepatitis86
  • Nausea (named in the label)85
  • Urticaria (named in the label)85
  • Drug Ineffective (a use or a product term, not a reaction)84
  • Fall83
  • Injury83
  • Muscular Weakness83
  • Gastrooesophageal Reflux Disease82
  • Inflammation79
  • Hypoaesthesia77
  • Joint Swelling77
  • Liver Function Test Increased77
  • Folliculitis76
  • Bursitis75
  • Finger Deformity74

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Tetracycline: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions