TRIAL RESULTS · SIDE EFFECTS
Vancomycin side effects
ANSWER
In 5 placebo-controlled trials with posted results, the most common side effects of Vancomycin were cough 16.1% (placebo 12.3%), headache 5.8% (placebo 6.4%), nausea 5.0% (placebo 5.3%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
61
with an arm on Vancomycin, of 738 registered
Against placebo
5
placebo-controlled trials
People in those trials
610
on Vancomycin · 402 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Vancomycin beside placebo
Share of people with each side effect in 5 placebo-controlled trials with posted results: 610 people on Vancomycin (all doses), 402 on placebo, same trials. Listed only when reported for at least half of the people on Vancomycin. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 1802 side effects reported
Every trial with posted results and an arm on Vancomycin (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Vancomycin | Placebo | Trials |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 6.5% (559 of 8,615) | 5.3% | 31 |
| Headache | Nervous system disorders | 5.6% (478 of 8,480) | 6.4% | 28 |
| Diarrhoea | Gastrointestinal disorders | 5.8% (372 of 6,434) | 4.8% | 25 |
| Constipation | Gastrointestinal disorders | 4.4% (264 of 6,049) | 10.7% | 20 |
| Vomiting | Gastrointestinal disorders | 3.2% (235 of 7,430) | 5.2% | 29 |
| Insomnia | Psychiatric disorders | 4.3% (212 of 4,911) | - | 14 |
| Pyrexia | General disorders | 2.4% (160 of 6,777) | 4.4% | 24 |
| Pruritus | Skin and subcutaneous tissue disorders | 5.0% (156 of 3,150) | 28.6% | 11 |
| Rash | Skin and subcutaneous tissue disorders | 2.6% (147 of 5,717) | - | 20 |
| Pruritis | Skin and subcutaneous tissue disorders | 11.4% (141 of 1,234) | - | 4 |
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | 52.0% (129 of 248) | 60.2% | 1 |
| Adverse effects | Product Issues | 42.7% (128 of 300) | - | 1 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3.6% (123 of 3,449) | 12.3% | 12 |
| Hypotension | Vascular disorders | 2.3% (113 of 4,856) | - | 15 |
| Anemia | Blood and lymphatic system disorders | 5.2% (112 of 2,145) | - | 6 |
| Hypertension | Vascular disorders | 2.3% (103 of 4,465) | - | 13 |
| Dizziness | Nervous system disorders | 2.5% (102 of 4,055) | - | 12 |
| Abdominal pain | Gastrointestinal disorders | 2.0% (99 of 4,985) | 11.4% | 17 |
| Hypokalemia | Metabolism and nutrition disorders | 5.8% (99 of 1,702) | - | 6 |
| Hypokalaemia | Metabolism and nutrition disorders | 2.9% (96 of 3,289) | - | 9 |
| Anxiety | Psychiatric disorders | 2.4% (77 of 3,270) | - | 9 |
| Anaemia | Blood and lymphatic system disorders | 2.3% (76 of 3,317) | - | 11 |
| Fatigue | General disorders | 1.8% (74 of 4,009) | 5.7% | 13 |
| Dysgeusia | Nervous system disorders | 3.5% (67 of 1,900) | - | 5 |
| Pneumonia | Infections and infestations | 0.8% (65 of 8,015) | 4.1% | 25 |
| Diarrhea | Gastrointestinal disorders | 3.2% (62 of 1,945) | 0.0% | 7 |
| Pruritis generalized | Skin and subcutaneous tissue disorders | 6.4% (60 of 938) | - | 2 |
| nausea | Gastrointestinal disorders | 12.0% (60 of 502) | - | 1 |
| Hypoglycaemia | Metabolism and nutrition disorders | 1.3% (59 of 4,657) | - | 14 |
| Erythema | Skin and subcutaneous tissue disorders | 1.4% (59 of 4,146) | - | 12 |
| Hypomagnesaemia | Metabolism and nutrition disorders | 1.9% (58 of 3,053) | - | 8 |
| Atrial fibrillation | Cardiac disorders | 1.3% (55 of 4,109) | - | 11 |
| Agitation | Psychiatric disorders | 1.9% (53 of 2,761) | - | 8 |
| Urinary tract infection | Infections and infestations | 1.8% (51 of 2,903) | - | 9 |
| Sepsis | Infections and infestations | 0.8% (50 of 6,483) | 1.0% | 20 |
| Infusion site reaction | General disorders | 2.5% (49 of 1,934) | - | 4 |
| Oedema Peripheral | General disorders | 4.1% (49 of 1,181) | - | 3 |
| Cellulitis | Infections and infestations | 0.7% (46 of 6,247) | 2.4% | 22 |
| Cardiac failure congestive | Cardiac disorders | 0.8% (46 of 5,771) | 0.0% | 18 |
| Infusion site pain | General disorders | 3.0% (45 of 1,493) | - | 4 |
| Decubitis Ulcer | Skin and subcutaneous tissue disorders | 5.9% (44 of 752) | - | 2 |
| Dyspepsia | Gastrointestinal disorders | 1.5% (42 of 2,892) | - | 8 |
| Hyperkalaemia | Metabolism and nutrition disorders | 1.5% (40 of 2,624) | - | 7 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1.2% (39 of 3,329) | 4.1% | 9 |
| Infusion site extravasation | General disorders | 2.5% (39 of 1,583) | - | 3 |
| Alanine Aminotransferase increased | Investigations | 3.1% (39 of 1,261) | - | 3 |
| Septic shock | Infections and infestations | 0.9% (37 of 4,110) | 2.4% | 12 |
| Urinary Tract Infection | Infections and infestations | 2.1% (37 of 1,727) | 2.4% | 5 |
| Oedema peripheral | General disorders | 1.6% (36 of 2,194) | - | 6 |
| Clostridium difficile infection | Infections and infestations | 2.9% (36 of 1,250) | - | 5 |
| Hyperglycaemia | Metabolism and nutrition disorders | 1.4% (35 of 2,498) | - | 6 |
| Infusion site phlebitis | General disorders | 1.4% (35 of 2,414) | - | 5 |
| Unplanned Medical Visit | General disorders | 6.3% (35 of 552) | - | 1 |
| Pain | General disorders | 0.9% (33 of 3,579) | - | 9 |
| Tachycardia | Cardiac disorders | 1.3% (33 of 2,617) | - | 8 |
| Asthenia | General disorders | 0.9% (32 of 3,523) | - | 11 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 0.9% (32 of 3,529) | - | 11 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 0.9% (32 of 3,384) | - | 9 |
| Abdominal Pain | Gastrointestinal disorders | 1.8% (32 of 1,786) | - | 5 |
| Allergy Symptoms | Immune system disorders | 5.8% (32 of 552) | - | 1 |
| Bradycardia | Cardiac disorders | 1.1% (31 of 2,929) | - | 7 |
| Aspartate Aminotransferase increased | Investigations | 2.5% (31 of 1,261) | - | 3 |
| Thrombocytopenia | Blood and lymphatic system disorders | 0.8% (30 of 3,655) | - | 10 |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 2.4% (30 of 1,247) | - | 4 |
| NAUSEA | Gastrointestinal disorders | 11.5% (30 of 260) | - | 1 |
| Gastrointestinal changes | Metabolism and nutrition disorders | 5.4% (30 of 552) | - | 1 |
| Decreased appetite | Metabolism and nutrition disorders | 1.1% (29 of 2,735) | 5.1% | 7 |
| Renal Failure Acute | Renal and urinary disorders | 1.6% (29 of 1,786) | - | 5 |
| pruritus | Skin and subcutaneous tissue disorders | 5.8% (29 of 502) | - | 1 |
| Infusion site erythema | General disorders | 1.3% (28 of 2,110) | - | 5 |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 1.5% (28 of 1,924) | - | 5 |
| headache | Nervous system disorders | 5.6% (28 of 502) | - | 1 |
| vomiting | Gastrointestinal disorders | 5.6% (28 of 502) | - | 1 |
| Back pain | Musculoskeletal and connective tissue disorders | 0.9% (27 of 2,985) | 1.0% | 9 |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | 1.5% (27 of 1,749) | - | 5 |
| Chills | General disorders | 1.0% (25 of 2,384) | - | 7 |
| Pruritus generalized | Skin and subcutaneous tissue disorders | 3.0% (25 of 828) | - | 2 |
| Persistent Wound Drainage or Dehiscence | Skin and subcutaneous tissue disorders | 2.5% (25 of 1,000) | - | 1 |
| Hearing Change | Ear and labyrinth disorders | 4.3% (24 of 552) | - | 1 |
| Dehydration | Metabolism and nutrition disorders | 0.6% (23 of 3,584) | 0.7% | 13 |
| Renal failure acute | Renal and urinary disorders | 0.8% (23 of 2,982) | - | 12 |
| Upper respiratory tract infection | Infections and infestations | 1.3% (23 of 1,797) | 4.1% | 5 |
| Dry Mouth | Gastrointestinal disorders | 2.3% (22 of 938) | - | 2 |
| Hyponatremia | Metabolism and nutrition disorders | 2.9% (22 of 752) | - | 2 |
| Hyponatraemia | Metabolism and nutrition disorders | 0.9% (21 of 2,234) | - | 5 |
| Red man syndrome | Skin and subcutaneous tissue disorders | 1.7% (21 of 1,204) | - | 4 |
| VOMITING | Gastrointestinal disorders | 3.4% (21 of 624) | - | 3 |
| Rigors | General disorders | 2.2% (21 of 938) | - | 2 |
| Cardiac arrest | Cardiac disorders | 0.8% (20 of 2,389) | - | 7 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 1.4% (20 of 1,420) | 12.2% | 4 |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | 2.7% (20 of 752) | - | 2 |
| Clostridium difficile colitis | Infections and infestations | 1.0% (19 of 1,976) | - | 6 |
| Hyperglycemia | Metabolism and nutrition disorders | 1.1% (19 of 1,772) | - | 5 |
| Urine Abnormality | Renal and urinary disorders | 3.7% (19 of 509) | - | 1 |
| Cardiac failure | Cardiac disorders | 0.4% (18 of 4,817) | - | 13 |
| Convulsion | Nervous system disorders | 0.5% (18 of 3,525) | - | 11 |
| Renal failure | Renal and urinary disorders | 0.4% (18 of 4,006) | - | 11 |
| Leukocytosis | Blood and lymphatic system disorders | 0.9% (18 of 2,099) | 1.0% | 7 |
| Aspartate aminotransferase increased | Investigations | 0.8% (18 of 2,250) | - | 7 |
| Depression | Psychiatric disorders | 0.7% (18 of 2,602) | - | 7 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
FDA LABEL
What the FDA label says
TYZAVAN NDA211962 · label of 2026-08-19 Regulator
The most common adverse reactions are anaphylaxis, “vancomycin infusion reactions”, acute kidney injury, hearing loss, neutropenia.
Vancomycin Hydrochloride ANDA210729 · label of 2026-08-17 Regulator
The most common adverse reactions (≥ 10%) were nausea (17%), abdominal pain (15%), and hypokalemia (13%).
Vancomycin Hydrochloride for Oral Solution NDA208910 · label of 2026-07-14 Regulator
The most common adverse reactions (≥ 10%) were nausea (17%), abdominal pain (15%), and hypokalemia (13%).
QUESTIONS
Does vancomycin cause cough?
In 5 placebo-controlled trials with posted results, 16.1% of people on vancomycin reported cough, against 12.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does vancomycin cause headache?
In 5 placebo-controlled trials with posted results, 5.8% of people on vancomycin reported headache, against 6.4% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does vancomycin cause nausea?
In 5 placebo-controlled trials with posted results, 5.0% of people on vancomycin reported nausea, against 5.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does vancomycin cause pyrexia?
In 5 placebo-controlled trials with posted results, 5.0% of people on vancomycin reported pyrexia, against 4.4% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does vancomycin cause diarrhoea?
In 5 placebo-controlled trials with posted results, 4.7% of people on vancomycin reported diarrhoea, against 4.8% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
738 registered clinical trials of Vancomycin
The 10 most recently updated are listed.
| NCT02764359 | Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens Status: COMPLETED · Updated 2026-10-01 |
|---|---|
| 2025-520452-28-00 | Fecal microbiota transfer for the secondary prevention of recurrent urinary tract infections in premenopausal women: a phase II trial (FEMITRANS) Status: UNKNOWN · Updated 2026-09-30 |
| NCT03765567 | Placement of Antibiotic Powder in Wounds During the Emergency Room Status: RECRUITING · Updated 2026-09-30 |
| NCT04731025 | Local Antibiotics for Breast Implants Status: ACTIVE_NOT_RECRUITING · Updated 2026-09-29 |
| NCT05539729 | Vancomycin Study in Multiple Sclerosis (MS) Status: RECRUITING · Updated 2026-09-28 |
| 2024-510921-25-00 | Antibiotic Impregnated Bone Graft to reduce infection in hip replacement - the ABOGRAFT trial Status: UNKNOWN · Updated 2026-09-25 |
| NCT06772675 | Vancomycin Reduction Practices (VRP) in the NICU Status: RECRUITING · Updated 2026-09-24 |
| NCT07328971 | Vancomycin Taper to Prevent Recurrent Clostridioides Difficile Status: RECRUITING · Updated 2026-09-23 |
| NCT06426836 | Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO) Status: RECRUITING · Updated 2026-09-21 |
| 2026-525632-41-00 | Randomized Controlled Trial Assessing the Effectiveness and Safety of Fecal Microbiota Transfer for VRE Eradication in Immunocompromised Patients (EU CTR, Phase II) - VRE-ex Status: UNKNOWN · Updated 2026-09-18 |
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