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Drug side effects

tetracycline Side Effects

The reactions most often reported to the FDA for tetracycline (also sold as Sumycin), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

741
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of tetracycline come from 741 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 741 reports to the FDA Adverse Event Reporting System (FAERS) for tetracycline (Sumycin): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

741

Reports Mentioning Death

199

26.9% of reports — not proof the medicine caused the death

Hospitalizations

268

36.2% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG HYPERSENSITIVITY
151
HYPERSENSITIVITY
123
PNEUMONIA
103
PAIN IN EXTREMITY
93
ARTHRALGIA
90
MOBILITY DECREASED
89
NECK PAIN
88
HEPATITIS
84
VOMITING
83
URTICARIA
82
FALL
81
MUSCULAR WEAKNESS
81
NAUSEA
81
GASTROOESOPHAGEAL REFLUX DISEASE
80
INJURY
80
INFLAMMATION
77
FOLLICULITIS
75

Who Reports Side Effects

Gender Distribution

Female 465 (81%)
Male 111 (19%)
Unknown 1

Age Distribution

0-17 23 (5%)
18-44 221 (52%)
45-64 74 (17%)
65-74 69 (16%)
75+ 41 (10%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 199 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
PNEUMONIA 81
MOBILITY DECREASED 78
PAIN IN EXTREMITY 78
NECK PAIN 77
INJURY 70
MUSCULAR WEAKNESS 70
FALL 69
GASTROOESOPHAGEAL REFLUX DISEASE 67
HEPATITIS 67
INFLAMMATION 67
BURSITIS 66
FINGER DEFORMITY 66
LIVER FUNCTION TEST INCREASED 66
FOLLICULITIS 65
HYPOAESTHESIA 65
WEIGHT INCREASED 57
WHEEZING 57
BACK INJURY 56

Reactions in Hospitalization Reports

Top reactions in 268 reports where hospitalization was an outcome.

Reaction Reports
PNEUMONIA 102
PAIN IN EXTREMITY 89
MOBILITY DECREASED 88
NECK PAIN 87
HEPATITIS 83
FALL 79
INJURY 79
MUSCULAR WEAKNESS 79
GASTROOESOPHAGEAL REFLUX DISEASE 76
INFLAMMATION 76
BURSITIS 74
FOLLICULITIS 74
HYPOAESTHESIA 74
LIVER FUNCTION TEST INCREASED 74
FINGER DEFORMITY 73
WHEEZING 66
VOMITING 64
WEIGHT INCREASED 64

Compare tetracycline vs amikacin →

What the FAERS Data Reveals About tetracycline Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 741 voluntary reports linked to tetracycline and its brand equivalents (Sumycin), spanning 2004 through 2025. Of those, 199 (26.9%) listed death as an outcome and 268 (36.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 81% were female and 19% male; age distribution skews toward 18-44, with 221 reports in that bracket. The single most reported reaction is drug hypersensitivity with 151 submissions, followed by hypersensitivity and pneumonia.

How to read these numbers

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to tetracycline's 741.