tetracycline Side Effects
Also known as: Sumycin
Analysis of 741 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
741
Death-Related
199
26.9% of reports
Hospitalizations
268
36.2% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
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 |
|---|---|
| OFF LABEL USE | 118 |
| INTENTIONAL PRODUCT USE ISSUE | 82 |
| 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 |
|---|---|
| OFF LABEL USE | 143 |
| PNEUMONIA | 102 |
| INTENTIONAL PRODUCT USE ISSUE | 95 |
| 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 |
Nearby — Related Medications
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 off label use with 213 submissions, followed by drug hypersensitivity and hypersensitivity.
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.
Read our methodology — how this data is sourced, computed, and verified.