Drug
Sterile Water
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Hereditary Angioedema | 555 | 273.1 | 313.6 | signal |
| 2 | Poor Venous Access | 79 | 37.7 | 38.4 | signal |
| 3 | Product Packaging Quantity Issue | 51 | 23.0 | 23.2 | signal |
| 4 | Insurance Issue | 67 | 22.2 | 22.5 | signal |
| 5 | Myelosuppression | 129 | 18.6 | 19.2 | signal |
| 6 | Prescribed Overdose | 72 | 18.3 | 18.6 | signal |
| 7 | Device Related Infection | 48 | 15.3 | 15.4 | signal |
| 8 | Infusion Site Pain | 36 | 13.8 | 13.9 | signal |
| 9 | Pharyngitis Streptococcal | 29 | 13.1 | 13.2 | signal |
| 10 | Poor Quality Product Administered | 27 | 13.0 | 13.0 | signal |
| 11 | Dermatitis Contact | 27 | 11.7 | 11.7 | signal |
| 12 | Weight Fluctuation | 23 | 10.8 | 10.9 | signal |
| 13 | Gastroenteritis Viral | 36 | 9.7 | 9.8 | signal |
| 14 | Seasonal Allergy | 24 | 8.3 | 8.4 | signal |
| 15 | Respiratory Tract Infection | 39 | 7.4 | 7.4 | signal |
| 16 | Pharyngeal Oedema | 23 | 7.2 | 7.3 | signal |
| 17 | Ear Infection | 39 | 7.2 | 7.3 | signal |
| 18 | Product Preparation Error | 28 | 6.6 | 6.7 | signal |
| 19 | Sars-cov-2 Test Positive | 18 | 6.6 | 6.6 | signal |
| 20 | Sinusitis | 137 | 6.5 | 6.7 | signal |
| 21 | Ligament Sprain | 13 | 6.5 | 6.5 | signal |
| 22 | Complication Associated With Device | 17 | 6.3 | 6.3 | signal |
| 23 | Drug Effect Incomplete | 45 | 6.0 | 6.0 | signal |
| 24 | Respiratory Tract Congestion | 19 | 5.8 | 5.9 | signal |
| 25 | Sinus Congestion | 16 | 5.8 | 5.8 | signal |
| 26 | Tenderness | 12 | 5.6 | 5.6 | signal |
| 27 | Inappropriate Schedule Of Product Administration | 201 | 5.6 | 5.8 | signal |
| 28 | Product Availability Issue | 25 | 5.5 | 5.5 | signal |
| 29 | Bacteraemia | 13 | 5.4 | 5.4 | signal |
| 30 | Ear Discomfort | 11 | 5.3 | 5.3 | signal |
| 31 | Eye Infection | 12 | 5.2 | 5.3 | signal |
| 32 | Upper Respiratory Tract Infection | 47 | 5.0 | 5.0 | signal |
| 33 | Dyspnoea Exertional | 38 | 5.0 | 5.0 | signal |
| 34 | Neutrophil Count Decreased | 41 | 5.0 | 5.0 | signal |
| 35 | Incorrect Route Of Product Administration | 17 | 5.0 | 5.0 | signal |
| 36 | Skin Infection | 11 | 4.8 | 4.8 | signal |
| 37 | Infusion Related Reaction | 65 | 4.8 | 4.9 | signal |
| 38 | Circumstance Or Information Capable Of Leading To Medication Error | 33 | 4.8 | 4.8 | signal |
| 39 | Weight Increased | 217 | 4.8 | 5.0 | signal |
| 40 | Illness | 95 | 4.6 | 4.7 | signal |
| 41 | Drug Dispensing Error | 14 | 4.4 | 4.4 | signal |
| 42 | Candida Infection | 15 | 4.4 | 4.4 | signal |
| 43 | Viral Infection | 29 | 4.3 | 4.3 | signal |
| 44 | Neuralgia | 21 | 4.2 | 4.3 | signal |
| 45 | Bacterial Infection | 16 | 4.2 | 4.2 | signal |
| 46 | Wrist Fracture | 10 | 4.1 | 4.1 | signal |
| 47 | Product Dose Omission Issue | 237 | 4.1 | 4.3 | signal |
| 48 | Kidney Infection | 16 | 4.0 | 4.0 | signal |
| 49 | Covid-19 | 144 | 4.0 | 4.1 | signal |
| 50 | Limb Injury | 22 | 4.0 | 4.0 | signal |
| 51 | Nasopharyngitis | 146 | 3.9 | 4.0 | signal |
| 52 | Ear Pain | 15 | 3.8 | 3.8 | signal |
| 53 | Stress | 55 | 3.7 | 3.8 | signal |
| 54 | Influenza | 85 | 3.7 | 3.8 | signal |
| 55 | Scar | 13 | 3.7 | 3.7 | signal |
| 56 | Pneumothorax | 12 | 3.7 | 3.7 | signal |
| 57 | No Adverse Event | 134 | 3.7 | 3.8 | signal |
| 58 | Weight Decreased | 209 | 3.7 | 3.8 | signal |
| 59 | Foot Fracture | 14 | 3.6 | 3.6 | signal |
| 60 | Body Temperature Increased | 15 | 3.6 | 3.6 | signal |
| 61 | Staphylococcal Infection | 24 | 3.5 | 3.6 | signal |
| 62 | Brain Oedema | 9 | 3.5 | 3.5 | signal |
| 63 | Product Dose Omission In Error | 19 | 3.5 | 3.5 | signal |
| 64 | Chills | 82 | 3.4 | 3.5 | signal |
| 65 | Productive Cough | 33 | 3.4 | 3.4 | signal |
| 66 | Throat Tightness | 18 | 3.3 | 3.3 | signal |
| 67 | Fungal Infection | 22 | 3.2 | 3.2 | signal |
| 68 | Cystitis | 21 | 3.2 | 3.2 | signal |
| 69 | Sinus Disorder | 13 | 3.2 | 3.2 | signal |
| 70 | Skin Laceration | 7 | 3.2 | 3.2 | signal |
| 71 | Product Packaging Issue | 6 | 3.2 | 3.2 | signal |
| 72 | Pharyngitis | 8 | 3.1 | 3.1 | signal |
| 73 | Anaphylactic Reaction | 35 | 3.1 | 3.1 | signal |
| 74 | Dialysis | 9 | 3.1 | 3.1 | signal |
| 75 | Nasal Congestion | 37 | 3.1 | 3.1 | signal |
| 76 | Dizziness Postural | 6 | 3.1 | 3.1 | signal |
| 77 | Chest Discomfort | 63 | 3.0 | 3.1 | signal |
| 78 | Brain Fog | 9 | 3.0 | 3.0 | signal |
| 79 | Inappropriate Schedule Of Drug Administration | 44 | 3.0 | 3.0 | signal |
| 80 | Wheezing | 36 | 3.0 | 3.0 | signal |
| 81 | Osteomyelitis | 11 | 3.0 | 3.0 | signal |
| 82 | Joint Injury | 13 | 3.0 | 3.0 | signal |
| 83 | Pregnancy | 12 | 2.9 | 2.9 | signal |
| 84 | Intentional Dose Omission | 16 | 2.9 | 2.9 | signal |
| 85 | Product Use Complaint | 9 | 2.8 | 2.8 | signal |
| 86 | Scratch | 6 | 2.8 | 2.8 | signal |
| 87 | Localised Infection | 14 | 2.8 | 2.8 | signal |
| 88 | Spinal Operation | 7 | 2.8 | 2.8 | signal |
| 89 | Device Occlusion | 8 | 2.8 | 2.8 | signal |
| 90 | Post Procedural Complication | 11 | 2.8 | 2.8 | signal |
| 91 | White Blood Cell Count Decreased | 62 | 2.8 | 2.8 | signal |
| 92 | Mass | 8 | 2.8 | 2.8 | signal |
| 93 | Bronchitis | 42 | 2.8 | 2.8 | signal |
| 94 | Retching | 12 | 2.8 | 2.8 | signal |
| 95 | Tooth Extraction | 7 | 2.8 | 2.8 | signal |
| 96 | Impaired Quality Of Life | 8 | 2.7 | 2.7 | signal |
| 97 | Road Traffic Accident | 23 | 2.7 | 2.7 | signal |
| 98 | Pulmonary Thrombosis | 6 | 2.7 | 2.7 | signal |
| 99 | Exposure During Pregnancy | 34 | 2.7 | 2.7 | signal |
| 100 | Heart Rate Increased | 54 | 2.7 | 2.7 | signal |
| 101 | Tooth Fracture | 6 | 2.7 | 2.7 | signal |
| 102 | Burning Sensation | 38 | 2.7 | 2.7 | signal |
| 103 | Product Prescribing Issue | 11 | 2.6 | 2.6 | signal |
| 104 | Product Use Issue | 101 | 2.6 | 2.7 | signal |
| 105 | Appendicitis | 5 | 2.6 | 2.6 | no signal |
| 106 | Feeling Cold | 15 | 2.6 | 2.6 | signal |
| 107 | Thrombosis | 43 | 2.6 | 2.6 | signal |
| 108 | Contusion | 51 | 2.6 | 2.6 | signal |
| 109 | Pain In Jaw | 15 | 2.6 | 2.6 | signal |
| 110 | Gastrointestinal Disorder | 46 | 2.5 | 2.6 | signal |
| 111 | Therapy Change | 5 | 2.5 | 2.5 | no signal |
| 112 | Tachypnoea | 7 | 2.5 | 2.5 | signal |
| 113 | Hospitalisation | 78 | 2.5 | 2.5 | signal |
| 114 | Blood Iron Decreased | 6 | 2.5 | 2.5 | no signal |
| 115 | Cough | 141 | 2.5 | 2.5 | signal |
| 116 | Diplopia | 13 | 2.4 | 2.5 | signal |
| 117 | Migraine | 47 | 2.4 | 2.4 | signal |
| 118 | Temperature Intolerance | 5 | 2.4 | 2.4 | no signal |
| 119 | Drug Ineffective For Unapproved Indication | 27 | 2.4 | 2.4 | signal |
| 120 | Transfusion | 5 | 2.3 | 2.3 | no signal |
| 121 | Maternal Exposure During Pregnancy | 41 | 2.3 | 2.3 | signal |
| 122 | Oropharyngeal Pain | 43 | 2.3 | 2.3 | signal |
| 123 | Laryngitis | 5 | 2.3 | 2.3 | no signal |
| 124 | Gastrointestinal Pain | 5 | 2.2 | 2.2 | no signal |
| 125 | Tooth Infection | 6 | 2.2 | 2.2 | no signal |
| 126 | Cold Sweat | 8 | 2.2 | 2.2 | signal |
| 127 | Adverse Reaction | 6 | 2.2 | 2.2 | no signal |
| 128 | Obstructive Airways Disorder | 5 | 2.2 | 2.2 | no signal |
| 129 | Sneezing | 10 | 2.2 | 2.2 | signal |
| 130 | Full Blood Count Decreased | 9 | 2.2 | 2.2 | signal |
| 131 | Rhinorrhoea | 28 | 2.1 | 2.1 | signal |
| 132 | Diverticulitis | 12 | 2.1 | 2.1 | signal |
| 133 | Blood Thyroid Stimulating Hormone Increased | 4 | 2.1 | 2.1 | no signal |
| 134 | Drug Level Increased | 7 | 2.1 | 2.1 | no signal |
| 135 | Inability To Afford Medication | 4 | 2.0 | 2.0 | no signal |
| 136 | Device Issue | 34 | 1.9 | 1.9 | no signal |
| 137 | Throat Irritation | 17 | 1.9 | 1.9 | no signal |
| 138 | Agranulocytosis | 7 | 1.9 | 1.9 | no signal |
| 139 | Eye Haemorrhage | 5 | 1.8 | 1.8 | no signal |
| 140 | Hernia | 7 | 1.8 | 1.8 | no signal |
| 141 | Anaphylactic Shock | 9 | 1.7 | 1.7 | no signal |
| 142 | Upper Limb Fracture | 7 | 1.7 | 1.7 | no signal |
| 143 | Hypoacusis | 15 | 1.7 | 1.7 | no signal |
| 144 | Pulmonary Arterial Hypertension | 5 | 1.7 | 1.7 | no signal |
| 145 | Knee Arthroplasty | 7 | 1.6 | 1.6 | no signal |
| 146 | Cytopenia | 4 | 1.6 | 1.6 | no signal |
| 147 | Expired Product Administered | 11 | 1.6 | 1.6 | no signal |
| 148 | Procedural Pain | 9 | 1.6 | 1.6 | no signal |
| 149 | Skin Cancer | 7 | 1.6 | 1.6 | no signal |
| 150 | Injection Site Irritation | 4 | 1.5 | 1.5 | no signal |
| 151 | Sleep Disorder Due To A General Medical Condition | 5 | 1.5 | 1.5 | no signal |
| 152 | Knee Operation | 3 | 1.5 | 1.5 | no signal |
| 153 | Malignant Melanoma | 4 | 1.5 | 1.5 | no signal |
| 154 | Injection Site Discomfort | 3 | 1.4 | 1.4 | no signal |
| 155 | Product Odour Abnormal | 3 | 1.4 | 1.4 | no signal |
| 156 | Injection Site Urticaria | 7 | 1.4 | 1.4 | no signal |
| 157 | Incorrect Dose Administered | 59 | 1.3 | 1.3 | no signal |
| 158 | Product Storage Error | 22 | 1.2 | 1.2 | no signal |
| 159 | Injection Site Pain | 77 | 1.2 | 1.2 | no signal |
| 160 | Product Quality Issue | 34 | 1.2 | 1.2 | no signal |
| 161 | Product Physical Issue | 5 | 1.2 | 1.2 | no signal |
| 162 | Colitis Ulcerative | 11 | 1.2 | 1.2 | no signal |
| 163 | Therapy Interrupted | 17 | 1.2 | 1.2 | no signal |
| 164 | Needle Issue | 7 | 1.2 | 1.2 | no signal |
| 165 | Device Dislocation | 10 | 1.1 | 1.1 | no signal |
| 166 | Prostate Cancer | 16 | 1.0 | 1.0 | no signal |
| 167 | Injection Site Pruritus | 13 | 1.0 | 1.0 | no signal |
| 168 | Injection Site Warmth | 4 | 1.0 | 1.0 | no signal |
| 169 | Exposure Via Skin Contact | 4 | 0.9 | 0.9 | no signal |
| 170 | Extra Dose Administered | 7 | 0.9 | 0.9 | no signal |
| 171 | Skin Irritation | 8 | 0.9 | 0.9 | no signal |
| 172 | Device Use Issue | 3 | 0.8 | 0.8 | no signal |
| 173 | Injection Site Rash | 5 | 0.8 | 0.8 | no signal |
| 174 | Injection Site Reaction | 11 | 0.8 | 0.8 | no signal |
| 175 | Dermatitis Atopic | 8 | 0.8 | 0.8 | no signal |
| 176 | Injection Site Swelling | 12 | 0.8 | 0.8 | no signal |
| 177 | Therapeutic Response Shortened | 5 | 0.8 | 0.8 | no signal |
| 178 | Injury Associated With Device | 3 | 0.7 | 0.7 | no signal |
| 179 | Injection Site Erythema | 16 | 0.6 | 0.6 | no signal |
| 180 | Device Use Error | 4 | 0.6 | 0.6 | no signal |
| 181 | Device Breakage | 3 | 0.4 | 0.4 | no signal |