Drug
Sodium Ferric Gluconate Complex
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 | Appendicitis | 256 | 277.7 | 315.3 | signal |
| 2 | Ventricular Fibrillation | 222 | 199.4 | 222.4 | signal |
| 3 | Cardiogenic Shock | 251 | 175.5 | 198.7 | signal |
| 4 | Multiple Organ Dysfunction Syndrome | 257 | 91.1 | 103.4 | signal |
| 5 | Ascites | 260 | 87.4 | 99.4 | signal |
| 6 | Incorrect Route Of Product Administration | 127 | 74.6 | 79.3 | signal |
| 7 | Bacterial Infection | 137 | 72.8 | 77.8 | signal |
| 8 | Neuralgia | 133 | 54.1 | 57.6 | signal |
| 9 | Hyperlipidaemia | 63 | 51.8 | 53.3 | signal |
| 10 | Hyponatraemia | 258 | 45.2 | 51.3 | signal |
| 11 | End Stage Renal Disease | 83 | 44.4 | 46.1 | signal |
| 12 | Ulcer | 68 | 42.0 | 43.4 | signal |
| 13 | Gout | 69 | 37.8 | 39.0 | signal |
| 14 | Stress | 255 | 34.9 | 39.5 | signal |
| 15 | Blood Test Abnormal | 48 | 33.6 | 34.4 | signal |
| 16 | Blood Cholesterol Increased | 145 | 30.6 | 32.7 | signal |
| 17 | Infusion Related Reaction | 196 | 29.2 | 32.0 | signal |
| 18 | Aspiration | 30 | 27.2 | 27.6 | signal |
| 19 | Sepsis | 293 | 25.8 | 29.7 | signal |
| 20 | Abdominal Distension | 269 | 25.4 | 28.9 | signal |
| 21 | Chronic Obstructive Pulmonary Disease | 130 | 24.5 | 26.0 | signal |
| 22 | General Physical Health Deterioration | 285 | 24.4 | 28.0 | signal |
| 23 | Dry Mouth | 174 | 21.1 | 22.9 | signal |
| 24 | Micturition Urgency | 24 | 20.8 | 21.0 | signal |
| 25 | Iron Deficiency Anaemia | 19 | 20.3 | 20.5 | signal |
| 26 | Full Blood Count Abnormal | 21 | 19.6 | 19.7 | signal |
| 27 | Swelling | 181 | 19.0 | 20.7 | signal |
| 28 | Hypercholesterolaemia | 18 | 18.5 | 18.6 | signal |
| 29 | Diabetes Mellitus | 138 | 17.7 | 18.8 | signal |
| 30 | Abdominal Pain | 407 | 17.2 | 21.0 | signal |
| 31 | Thrombosis | 139 | 16.9 | 18.0 | signal |
| 32 | Anaphylactic Reaction | 93 | 16.6 | 17.3 | signal |
| 33 | Sleep Disorder | 118 | 16.6 | 17.5 | signal |
| 34 | Toxic Epidermal Necrolysis | 24 | 15.6 | 15.8 | signal |
| 35 | Intentional Product Misuse | 133 | 15.0 | 16.0 | signal |
| 36 | Obstructive Airways Disorder | 17 | 15.0 | 15.1 | signal |
| 37 | Liver Function Test Increased | 32 | 14.7 | 14.9 | signal |
| 38 | Joint Range Of Motion Decreased | 20 | 14.7 | 14.8 | signal |
| 39 | Sputum Discoloured | 14 | 14.5 | 14.6 | signal |
| 40 | Blood Pressure Decreased | 96 | 14.2 | 14.8 | signal |
| 41 | Pulmonary Embolism | 136 | 14.0 | 14.9 | signal |
| 42 | Drug Intolerance | 134 | 13.7 | 14.5 | signal |
| 43 | Flank Pain | 12 | 12.6 | 12.7 | signal |
| 44 | Paraesthesia Oral | 17 | 11.6 | 11.7 | signal |
| 45 | Lower Respiratory Tract Infection | 53 | 11.5 | 11.7 | signal |
| 46 | Constipation | 252 | 11.4 | 12.8 | signal |
| 47 | Stevens-johnson Syndrome | 25 | 11.0 | 11.1 | signal |
| 48 | Oedema Peripheral | 135 | 10.8 | 11.5 | signal |
| 49 | Pallor | 30 | 10.8 | 10.9 | signal |
| 50 | Transaminases Increased | 24 | 10.6 | 10.7 | signal |
| 51 | Hypotension | 210 | 10.3 | 11.3 | signal |
| 52 | Urticaria | 174 | 10.3 | 11.1 | signal |
| 53 | Joint Stiffness | 27 | 10.1 | 10.2 | signal |
| 54 | Joint Injury | 22 | 10.1 | 10.2 | signal |
| 55 | Musculoskeletal Stiffness | 89 | 10.0 | 10.4 | signal |
| 56 | Anaemia | 187 | 9.6 | 10.4 | signal |
| 57 | Vomiting | 455 | 9.5 | 11.8 | signal |
| 58 | Pleural Effusion | 59 | 9.5 | 9.7 | signal |
| 59 | Pulmonary Fibrosis | 18 | 9.2 | 9.3 | signal |
| 60 | Pulmonary Mass | 14 | 9.2 | 9.3 | signal |
| 61 | Chest Discomfort | 96 | 9.2 | 9.6 | signal |
| 62 | Somnolence | 188 | 9.2 | 10.0 | signal |
| 63 | Unresponsive To Stimuli | 24 | 9.2 | 9.2 | signal |
| 64 | Coronary Artery Disease | 28 | 9.0 | 9.1 | signal |
| 65 | Cold Sweat | 16 | 8.9 | 9.0 | signal |
| 66 | Hypotonia | 9 | 8.8 | 8.8 | signal |
| 67 | Swollen Tongue | 28 | 8.8 | 8.9 | signal |
| 68 | Burning Sensation | 62 | 8.7 | 8.9 | signal |
| 69 | Blood Creatinine Increased | 57 | 8.5 | 8.8 | signal |
| 70 | Aspartate Aminotransferase Increased | 45 | 8.3 | 8.5 | signal |
| 71 | Hyperhidrosis | 106 | 8.1 | 8.4 | signal |
| 72 | Lip Swelling | 27 | 8.0 | 8.1 | signal |
| 73 | Cardiovascular Disorder | 20 | 7.7 | 7.7 | signal |
| 74 | Drug Hypersensitivity | 151 | 7.6 | 8.1 | signal |
| 75 | Heart Rate Decreased | 27 | 7.5 | 7.6 | signal |
| 76 | Blood Iron Decreased | 9 | 7.5 | 7.5 | signal |
| 77 | Grand Mal Convulsion | 7 | 7.3 | 7.4 | signal |
| 78 | Hypoxia | 26 | 7.3 | 7.3 | signal |
| 79 | Throat Tightness | 20 | 7.3 | 7.3 | signal |
| 80 | Haemoptysis | 20 | 7.0 | 7.1 | signal |
| 81 | Dyspnoea | 385 | 6.7 | 7.9 | signal |
| 82 | Paraesthesia | 107 | 6.7 | 7.0 | signal |
| 83 | Syncope | 67 | 6.6 | 6.7 | signal |
| 84 | Presyncope | 16 | 6.5 | 6.5 | signal |
| 85 | Condition Aggravated | 197 | 6.4 | 6.9 | signal |
| 86 | Transient Ischaemic Attack | 22 | 6.4 | 6.4 | signal |
| 87 | Injection Site Discolouration | 8 | 6.3 | 6.3 | signal |
| 88 | Nausea | 508 | 6.3 | 8.0 | signal |
| 89 | Urinary Incontinence | 19 | 6.3 | 6.3 | signal |
| 90 | Hypertensive Crisis | 7 | 6.1 | 6.2 | signal |
| 91 | Muscle Tightness | 10 | 6.1 | 6.1 | signal |
| 92 | Peripheral Swelling | 93 | 5.9 | 6.2 | signal |
| 93 | Post Procedural Haemorrhage | 7 | 5.9 | 5.9 | signal |
| 94 | Motor Dysfunction | 6 | 5.8 | 5.8 | signal |
| 95 | Chest Pain | 109 | 5.8 | 6.0 | signal |
| 96 | Anaphylactic Shock | 15 | 5.7 | 5.8 | signal |
| 97 | Circulatory Collapse | 10 | 5.7 | 5.8 | signal |
| 98 | Cyanosis | 9 | 5.6 | 5.6 | signal |
| 99 | Bradycardia | 30 | 5.5 | 5.6 | signal |
| 100 | Back Pain | 130 | 5.5 | 5.8 | signal |
| 101 | Flushing | 55 | 5.3 | 5.4 | signal |
| 102 | Deformity | 5 | 5.2 | 5.2 | signal |
| 103 | Scar | 9 | 5.1 | 5.2 | signal |
| 104 | Peripheral Coldness | 7 | 5.0 | 5.0 | signal |
| 105 | Loss Of Consciousness | 65 | 5.0 | 5.1 | signal |
| 106 | Anhedonia | 13 | 4.8 | 4.8 | signal |
| 107 | Hypoaesthesia Oral | 7 | 4.6 | 4.6 | signal |
| 108 | Blood Pressure Systolic Increased | 9 | 4.5 | 4.5 | signal |
| 109 | Skin Discolouration | 20 | 4.3 | 4.3 | signal |
| 110 | Swelling Face | 28 | 4.2 | 4.3 | signal |
| 111 | Throat Irritation | 19 | 4.2 | 4.2 | signal |
| 112 | Dialysis | 6 | 4.1 | 4.1 | signal |
| 113 | Face Oedema | 7 | 4.1 | 4.1 | signal |
| 114 | Exposure During Pregnancy | 25 | 3.9 | 4.0 | signal |
| 115 | Injection Site Extravasation | 5 | 3.9 | 3.9 | signal |
| 116 | Hypothermia | 4 | 3.9 | 3.9 | signal |
| 117 | Feeling Hot | 24 | 3.8 | 3.9 | signal |
| 118 | Pharyngeal Oedema | 6 | 3.8 | 3.8 | signal |
| 119 | Local Swelling | 6 | 3.3 | 3.3 | signal |
| 120 | Injection Site Discomfort | 3 | 2.8 | 2.9 | no signal |
| 121 | Abasia | 7 | 2.7 | 2.7 | signal |
| 122 | Drug Exposure During Pregnancy | 9 | 2.6 | 2.6 | signal |
| 123 | Convulsion | 15 | 2.5 | 2.5 | signal |
| 124 | Caesarean Section | 3 | 2.5 | 2.5 | no signal |
| 125 | Anorexia | 3 | 2.3 | 2.3 | no signal |
| 126 | Hair Texture Abnormal | 3 | 2.2 | 2.2 | no signal |
| 127 | Premature Delivery | 3 | 1.8 | 1.8 | no signal |
| 128 | Injection Site Swelling | 14 | 1.8 | 1.8 | no signal |
| 129 | Wrong Technique In Drug Usage Process | 5 | 1.3 | 1.3 | no signal |