Drug
Sterile Water For Injection
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 | 576 | 238.6 | 268.9 | signal |
| 2 | Poor Venous Access | 85 | 34.1 | 34.7 | signal |
| 3 | Myelosuppression | 218 | 26.5 | 27.6 | signal |
| 4 | Product Packaging Quantity Issue | 52 | 19.7 | 19.9 | signal |
| 5 | Insurance Issue | 69 | 19.2 | 19.4 | signal |
| 6 | Prescribed Overdose | 72 | 15.3 | 15.5 | signal |
| 7 | Infusion Site Pain | 46 | 14.9 | 15.0 | signal |
| 8 | Device Related Infection | 54 | 14.4 | 14.6 | signal |
| 9 | Pharyngitis Streptococcal | 32 | 12.2 | 12.3 | signal |
| 10 | Poor Quality Product Administered | 28 | 11.3 | 11.3 | signal |
| 11 | Dermatitis Contact | 28 | 10.2 | 10.2 | signal |
| 12 | Weight Fluctuation | 25 | 9.9 | 9.9 | signal |
| 13 | Gastroenteritis Viral | 39 | 8.9 | 8.9 | signal |
| 14 | Respiratory Tract Infection | 48 | 7.6 | 7.7 | signal |
| 15 | Seasonal Allergy | 26 | 7.6 | 7.6 | signal |
| 16 | Product Preparation Error | 38 | 7.6 | 7.6 | signal |
| 17 | Sinus Congestion | 22 | 6.7 | 6.7 | signal |
| 18 | Ligament Sprain | 16 | 6.7 | 6.7 | signal |
| 19 | Ear Infection | 43 | 6.7 | 6.7 | signal |
| 20 | Pharyngeal Oedema | 23 | 6.1 | 6.1 | signal |
| 21 | Bone Marrow Failure | 30 | 6.0 | 6.1 | signal |
| 22 | Sinusitis | 148 | 5.9 | 6.1 | signal |
| 23 | Respiratory Tract Congestion | 22 | 5.7 | 5.7 | signal |
| 24 | Neutrophil Count Decreased | 56 | 5.7 | 5.7 | signal |
| 25 | Complication Associated With Device | 18 | 5.6 | 5.6 | signal |
| 26 | Sars-cov-2 Test Positive | 18 | 5.5 | 5.6 | signal |
| 27 | Circumstance Or Information Capable Of Leading To Medication Error | 43 | 5.3 | 5.3 | signal |
| 28 | Bacteraemia | 15 | 5.2 | 5.3 | signal |
| 29 | Drug Effect Incomplete | 45 | 5.0 | 5.1 | signal |
| 30 | Inappropriate Schedule Of Product Administration | 213 | 5.0 | 5.1 | signal |
| 31 | Illness | 119 | 4.9 | 5.0 | signal |
| 32 | Skin Infection | 13 | 4.8 | 4.8 | signal |
| 33 | Drug Dispensing Error | 18 | 4.8 | 4.8 | signal |
| 34 | Tenderness | 12 | 4.7 | 4.7 | signal |
| 35 | Upper Respiratory Tract Infection | 52 | 4.6 | 4.7 | signal |
| 36 | Infusion Related Reaction | 74 | 4.6 | 4.7 | signal |
| 37 | Dyspnoea Exertional | 42 | 4.6 | 4.6 | signal |
| 38 | Product Availability Issue | 25 | 4.6 | 4.6 | signal |
| 39 | Ear Discomfort | 11 | 4.4 | 4.4 | signal |
| 40 | Incorrect Route Of Product Administration | 18 | 4.4 | 4.4 | signal |
| 41 | Eye Infection | 12 | 4.4 | 4.4 | signal |
| 42 | Weight Increased | 232 | 4.3 | 4.4 | signal |
| 43 | Viral Infection | 34 | 4.2 | 4.2 | signal |
| 44 | Wrist Fracture | 12 | 4.1 | 4.1 | signal |
| 45 | Kidney Infection | 19 | 4.0 | 4.0 | signal |
| 46 | Limb Injury | 26 | 3.9 | 4.0 | signal |
| 47 | Candida Infection | 16 | 3.9 | 4.0 | signal |
| 48 | Neuralgia | 23 | 3.9 | 3.9 | signal |
| 49 | Bacterial Infection | 17 | 3.8 | 3.8 | signal |
| 50 | Chest Discomfort | 92 | 3.7 | 3.8 | signal |
| 51 | Nasopharyngitis | 166 | 3.7 | 3.8 | signal |
| 52 | No Adverse Event | 159 | 3.7 | 3.8 | signal |
| 53 | White Blood Cell Count Decreased | 97 | 3.7 | 3.7 | signal |
| 54 | Product Dose Omission Issue | 250 | 3.6 | 3.7 | signal |
| 55 | Ear Pain | 17 | 3.6 | 3.6 | signal |
| 56 | Product Packaging Issue | 8 | 3.5 | 3.5 | signal |
| 57 | Influenza | 96 | 3.5 | 3.6 | signal |
| 58 | Covid-19 | 150 | 3.5 | 3.6 | signal |
| 59 | Productive Cough | 40 | 3.5 | 3.5 | signal |
| 60 | Body Temperature Increased | 17 | 3.4 | 3.4 | signal |
| 61 | Pneumothorax | 13 | 3.4 | 3.4 | signal |
| 62 | Nasal Congestion | 48 | 3.4 | 3.4 | signal |
| 63 | Scar | 14 | 3.4 | 3.4 | signal |
| 64 | Agranulocytosis | 15 | 3.3 | 3.3 | signal |
| 65 | Stress | 58 | 3.3 | 3.3 | signal |
| 66 | Retching | 17 | 3.3 | 3.3 | signal |
| 67 | Full Blood Count Decreased | 16 | 3.3 | 3.3 | signal |
| 68 | Weight Decreased | 221 | 3.3 | 3.4 | signal |
| 69 | Brain Oedema | 10 | 3.3 | 3.3 | signal |
| 70 | Foot Fracture | 15 | 3.2 | 3.3 | signal |
| 71 | Abdominal Distension | 82 | 3.2 | 3.3 | signal |
| 72 | Chills | 89 | 3.1 | 3.2 | signal |
| 73 | Staphylococcal Infection | 25 | 3.1 | 3.1 | signal |
| 74 | Fungal Infection | 25 | 3.1 | 3.1 | signal |
| 75 | Joint Injury | 16 | 3.1 | 3.1 | signal |
| 76 | Flank Pain | 7 | 3.1 | 3.1 | signal |
| 77 | Skin Laceration | 8 | 3.0 | 3.0 | signal |
| 78 | Tachypnoea | 10 | 3.0 | 3.0 | signal |
| 79 | Therapy Change | 7 | 3.0 | 3.0 | signal |
| 80 | Cystitis | 23 | 3.0 | 3.0 | signal |
| 81 | Product Dose Omission In Error | 19 | 2.9 | 2.9 | signal |
| 82 | Sinus Disorder | 14 | 2.9 | 2.9 | signal |
| 83 | Dialysis | 10 | 2.9 | 2.9 | signal |
| 84 | Localised Infection | 17 | 2.9 | 2.9 | signal |
| 85 | Scratch | 7 | 2.8 | 2.8 | signal |
| 86 | Pain In Jaw | 19 | 2.8 | 2.8 | signal |
| 87 | Throat Tightness | 18 | 2.7 | 2.7 | signal |
| 88 | Osteomyelitis | 12 | 2.7 | 2.7 | signal |
| 89 | Spinal Operation | 8 | 2.7 | 2.7 | signal |
| 90 | Pallor | 18 | 2.7 | 2.7 | signal |
| 91 | Pyrexia | 226 | 2.7 | 2.8 | signal |
| 92 | Device Occlusion | 9 | 2.7 | 2.7 | signal |
| 93 | Wheezing | 38 | 2.6 | 2.7 | signal |
| 94 | Pharyngitis | 8 | 2.6 | 2.6 | signal |
| 95 | Anaphylactic Reaction | 35 | 2.6 | 2.6 | signal |
| 96 | Tooth Fracture | 7 | 2.6 | 2.6 | signal |
| 97 | Contusion | 61 | 2.6 | 2.6 | signal |
| 98 | Dizziness Postural | 6 | 2.6 | 2.6 | signal |
| 99 | Post Procedural Complication | 12 | 2.6 | 2.6 | signal |
| 100 | Cold Sweat | 11 | 2.6 | 2.6 | signal |
| 101 | Intentional Dose Omission | 17 | 2.6 | 2.6 | signal |
| 102 | Brain Fog | 9 | 2.5 | 2.5 | signal |
| 103 | Heart Rate Increased | 61 | 2.5 | 2.6 | signal |
| 104 | Burning Sensation | 43 | 2.5 | 2.5 | signal |
| 105 | Inappropriate Schedule Of Drug Administration | 44 | 2.5 | 2.5 | signal |
| 106 | Feeling Cold | 17 | 2.5 | 2.5 | signal |
| 107 | Tooth Infection | 8 | 2.5 | 2.5 | signal |
| 108 | Bronchitis | 45 | 2.5 | 2.5 | signal |
| 109 | Exposure During Pregnancy | 37 | 2.4 | 2.5 | signal |
| 110 | Thrombosis | 48 | 2.4 | 2.5 | signal |
| 111 | Cough | 166 | 2.4 | 2.5 | signal |
| 112 | Pregnancy | 12 | 2.4 | 2.4 | signal |
| 113 | Temperature Intolerance | 6 | 2.4 | 2.4 | no signal |
| 114 | Injection Site Discomfort | 6 | 2.4 | 2.4 | no signal |
| 115 | Product Use Complaint | 9 | 2.4 | 2.4 | signal |
| 116 | Hospitalisation | 87 | 2.3 | 2.4 | signal |
| 117 | Mass | 8 | 2.3 | 2.3 | signal |
| 118 | Migraine | 54 | 2.3 | 2.4 | signal |
| 119 | Respiratory Disorder | 17 | 2.3 | 2.3 | signal |
| 120 | Tooth Extraction | 7 | 2.3 | 2.3 | no signal |
| 121 | Product Use Issue | 105 | 2.3 | 2.3 | signal |
| 122 | Rhinorrhoea | 36 | 2.3 | 2.3 | signal |
| 123 | Swelling | 52 | 2.3 | 2.3 | signal |
| 124 | Impaired Quality Of Life | 8 | 2.3 | 2.3 | signal |
| 125 | Blood Pressure Abnormal | 11 | 2.3 | 2.3 | signal |
| 126 | Gastrointestinal Disorder | 49 | 2.3 | 2.3 | signal |
| 127 | Laryngitis | 6 | 2.3 | 2.3 | no signal |
| 128 | Product Administration Error | 11 | 2.3 | 2.3 | signal |
| 129 | Road Traffic Accident | 23 | 2.3 | 2.3 | signal |
| 130 | Pulmonary Thrombosis | 6 | 2.3 | 2.3 | no signal |
| 131 | Gastrointestinal Pain | 6 | 2.3 | 2.3 | no signal |
| 132 | Product Prescribing Issue | 11 | 2.2 | 2.2 | signal |
| 133 | Diplopia | 14 | 2.2 | 2.2 | signal |
| 134 | Appendicitis | 5 | 2.2 | 2.2 | no signal |
| 135 | Sneezing | 12 | 2.2 | 2.2 | signal |
| 136 | Sputum Discoloured | 5 | 2.2 | 2.2 | no signal |
| 137 | Adverse Reaction | 7 | 2.2 | 2.2 | no signal |
| 138 | Nephrolithiasis | 24 | 2.2 | 2.2 | signal |
| 139 | Oropharyngeal Pain | 48 | 2.1 | 2.1 | signal |
| 140 | Gingival Bleeding | 7 | 2.1 | 2.1 | no signal |
| 141 | Head Discomfort | 9 | 2.1 | 2.1 | signal |
| 142 | Maternal Exposure During Pregnancy | 45 | 2.1 | 2.1 | signal |
| 143 | Blood Iron Decreased | 6 | 2.1 | 2.1 | no signal |
| 144 | Medication Error | 28 | 2.1 | 2.1 | signal |
| 145 | Platelet Count Decreased | 53 | 2.0 | 2.1 | signal |
| 146 | Ovarian Cyst | 5 | 2.0 | 2.0 | no signal |
| 147 | Hepatic Function Abnormal | 18 | 2.0 | 2.0 | no signal |
| 148 | Drug Ineffective For Unapproved Indication | 27 | 2.0 | 2.0 | no signal |
| 149 | Transfusion | 5 | 2.0 | 2.0 | no signal |
| 150 | Diverticulitis | 13 | 1.9 | 1.9 | no signal |
| 151 | Anaphylactic Shock | 12 | 1.9 | 1.9 | no signal |
| 152 | Unresponsive To Stimuli | 12 | 1.9 | 1.9 | no signal |
| 153 | Discomfort | 28 | 1.9 | 1.9 | no signal |
| 154 | Tinnitus | 21 | 1.9 | 1.9 | no signal |
| 155 | Upper Limb Fracture | 9 | 1.8 | 1.9 | no signal |
| 156 | Nephropathy Toxic | 5 | 1.8 | 1.8 | no signal |
| 157 | Obstructive Airways Disorder | 5 | 1.8 | 1.8 | no signal |
| 158 | Device Issue | 39 | 1.8 | 1.8 | no signal |
| 159 | Blood Thyroid Stimulating Hormone Increased | 4 | 1.8 | 1.8 | no signal |
| 160 | Drug Level Increased | 7 | 1.7 | 1.7 | no signal |
| 161 | Swollen Tongue | 13 | 1.7 | 1.7 | no signal |
| 162 | Hernia | 8 | 1.7 | 1.7 | no signal |
| 163 | Feeling Hot | 25 | 1.7 | 1.7 | no signal |
| 164 | Inability To Afford Medication | 4 | 1.7 | 1.7 | no signal |
| 165 | Throat Irritation | 18 | 1.7 | 1.7 | no signal |
| 166 | Injection Site Irritation | 5 | 1.6 | 1.6 | no signal |
| 167 | Sluggishness | 4 | 1.6 | 1.6 | no signal |
| 168 | Expired Product Administered | 13 | 1.6 | 1.6 | no signal |
| 169 | Eye Haemorrhage | 5 | 1.5 | 1.5 | no signal |
| 170 | Hypoacusis | 16 | 1.5 | 1.5 | no signal |
| 171 | Pulmonary Arterial Hypertension | 5 | 1.4 | 1.4 | no signal |
| 172 | Knee Arthroplasty | 7 | 1.4 | 1.4 | no signal |
| 173 | Cytopenia | 4 | 1.4 | 1.4 | no signal |
| 174 | Eye Pruritus | 11 | 1.4 | 1.4 | no signal |
| 175 | Flushing | 34 | 1.4 | 1.4 | no signal |
| 176 | Injection Site Urticaria | 8 | 1.4 | 1.4 | no signal |
| 177 | Intercepted Product Preparation Error | 4 | 1.3 | 1.4 | no signal |
| 178 | Wrong Technique In Drug Usage Process | 12 | 1.3 | 1.3 | no signal |
| 179 | Procedural Pain | 9 | 1.3 | 1.3 | no signal |
| 180 | Skin Cancer | 7 | 1.3 | 1.3 | no signal |
| 181 | Sleep Disorder Due To A General Medical Condition | 5 | 1.3 | 1.3 | no signal |
| 182 | Knee Operation | 3 | 1.3 | 1.3 | no signal |
| 183 | Incorrect Dose Administered | 69 | 1.3 | 1.3 | no signal |
| 184 | Product Storage Error | 26 | 1.2 | 1.2 | no signal |
| 185 | Malignant Melanoma | 4 | 1.2 | 1.2 | no signal |
| 186 | Product Odour Abnormal | 3 | 1.2 | 1.2 | no signal |
| 187 | Injection Site Pain | 87 | 1.2 | 1.2 | no signal |
| 188 | Product Quality Issue | 38 | 1.2 | 1.2 | no signal |
| 189 | Needle Issue | 8 | 1.1 | 1.1 | no signal |
| 190 | Fistula | 3 | 1.1 | 1.1 | no signal |
| 191 | Injection Site Rash | 8 | 1.1 | 1.1 | no signal |
| 192 | Device Dislocation | 11 | 1.0 | 1.0 | no signal |
| 193 | Product Physical Issue | 5 | 1.0 | 1.0 | no signal |
| 194 | Colitis Ulcerative | 11 | 1.0 | 1.0 | no signal |
| 195 | Therapy Interrupted | 17 | 1.0 | 1.0 | no signal |
| 196 | Incorrect Product Storage | 3 | 0.9 | 0.9 | no signal |
| 197 | Injection Site Reaction | 15 | 0.9 | 0.9 | no signal |
| 198 | Prostate Cancer | 16 | 0.8 | 0.8 | no signal |
| 199 | Injection Site Pruritus | 13 | 0.8 | 0.8 | no signal |
| 200 | Injection Site Warmth | 4 | 0.8 | 0.8 | no signal |
| 201 | Injection Site Swelling | 14 | 0.8 | 0.8 | no signal |
| 202 | Exposure Via Skin Contact | 4 | 0.7 | 0.7 | no signal |
| 203 | Extra Dose Administered | 7 | 0.7 | 0.7 | no signal |
| 204 | Skin Irritation | 8 | 0.7 | 0.7 | no signal |
| 205 | Device Use Issue | 3 | 0.7 | 0.7 | no signal |
| 206 | Injection Site Mass | 6 | 0.7 | 0.7 | no signal |
| 207 | Dermatitis Atopic | 8 | 0.7 | 0.7 | no signal |
| 208 | Therapeutic Response Shortened | 5 | 0.6 | 0.6 | no signal |
| 209 | Injury Associated With Device | 3 | 0.6 | 0.6 | no signal |
| 210 | Injection Site Erythema | 18 | 0.6 | 0.6 | no signal |
| 211 | Device Use Error | 4 | 0.5 | 0.5 | no signal |
| 212 | Device Leakage | 4 | 0.4 | 0.4 | no signal |
| 213 | Device Breakage | 3 | 0.3 | 0.3 | no signal |