Drug
Gadoterate Meglumine
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 | Sneezing | 130 | 33.6 | 34.8 | signal |
| 2 | Urticaria | 648 | 22.4 | 27.1 | signal |
| 3 | Throat Irritation | 163 | 21.0 | 21.9 | signal |
| 4 | Throat Tightness | 92 | 19.6 | 20.1 | signal |
| 5 | Pharyngeal Swelling | 32 | 19.2 | 19.4 | signal |
| 6 | Eyelid Oedema | 35 | 17.2 | 17.4 | signal |
| 7 | Bronchospasm | 40 | 16.1 | 16.2 | signal |
| 8 | Muscle Twitching | 61 | 15.2 | 15.4 | signal |
| 9 | Paraesthesia Oral | 36 | 14.4 | 14.5 | signal |
| 10 | Rash Maculo-papular | 50 | 13.0 | 13.1 | signal |
| 11 | Face Oedema | 38 | 12.9 | 13.0 | signal |
| 12 | Erythema | 422 | 11.8 | 13.2 | signal |
| 13 | Anaphylactic Shock | 51 | 11.4 | 11.6 | signal |
| 14 | Cold Sweat | 33 | 10.8 | 10.8 | signal |
| 15 | Eye Swelling | 69 | 10.7 | 10.9 | signal |
| 16 | Feeling Hot | 107 | 10.0 | 10.3 | signal |
| 17 | Anaphylactic Reaction | 94 | 9.8 | 10.1 | signal |
| 18 | Pharyngeal Oedema | 25 | 9.2 | 9.3 | signal |
| 19 | Eosinophilia | 28 | 9.2 | 9.3 | signal |
| 20 | Spinal Pain | 17 | 8.3 | 8.4 | signal |
| 21 | Cyanosis | 22 | 8.0 | 8.1 | signal |
| 22 | Lip Swelling | 46 | 8.0 | 8.0 | signal |
| 23 | Retching | 29 | 7.8 | 7.9 | signal |
| 24 | Skin Reaction | 19 | 7.8 | 7.8 | signal |
| 25 | Swelling Face | 84 | 7.4 | 7.6 | signal |
| 26 | Burning Sensation | 90 | 7.4 | 7.5 | signal |
| 27 | Lacrimation Increased | 38 | 7.3 | 7.4 | signal |
| 28 | Pruritus | 479 | 7.3 | 8.2 | signal |
| 29 | Feeling Cold | 35 | 7.2 | 7.3 | signal |
| 30 | Chest Discomfort | 127 | 7.2 | 7.4 | signal |
| 31 | Pallor | 33 | 7.0 | 7.0 | signal |
| 32 | Respiratory Distress | 32 | 6.7 | 6.7 | signal |
| 33 | Dysphonia | 67 | 6.6 | 6.7 | signal |
| 34 | Disturbance In Attention | 62 | 6.6 | 6.7 | signal |
| 35 | Head Discomfort | 20 | 6.5 | 6.6 | signal |
| 36 | Ocular Hyperaemia | 53 | 6.5 | 6.6 | signal |
| 37 | Brain Fog | 16 | 6.3 | 6.3 | signal |
| 38 | Unresponsive To Stimuli | 28 | 6.3 | 6.3 | signal |
| 39 | Motor Dysfunction | 11 | 6.2 | 6.3 | signal |
| 40 | Nasal Congestion | 63 | 6.2 | 6.3 | signal |
| 41 | Presyncope | 26 | 6.2 | 6.2 | signal |
| 42 | Erythema Multiforme | 10 | 6.2 | 6.2 | signal |
| 43 | Flank Pain | 10 | 6.1 | 6.2 | signal |
| 44 | Paraesthesia | 168 | 6.1 | 6.4 | signal |
| 45 | Hypoaesthesia Oral | 16 | 6.1 | 6.1 | signal |
| 46 | Cough | 295 | 6.1 | 6.5 | signal |
| 47 | Injection Site Extravasation | 13 | 6.0 | 6.0 | signal |
| 48 | Renal Pain | 11 | 6.0 | 6.0 | signal |
| 49 | Drug Reaction With Eosinophilia And Systemic Symptoms | 26 | 5.8 | 5.9 | signal |
| 50 | Sensory Disturbance | 16 | 5.7 | 5.7 | signal |
| 51 | Sinus Tachycardia | 14 | 5.7 | 5.7 | signal |
| 52 | Eye Pruritus | 32 | 5.6 | 5.6 | signal |
| 53 | Dyspnoea | 546 | 5.5 | 6.3 | signal |
| 54 | Oxygen Saturation Decreased | 52 | 5.4 | 5.4 | signal |
| 55 | Swollen Tongue | 29 | 5.3 | 5.4 | signal |
| 56 | Muscle Tightness | 15 | 5.3 | 5.3 | signal |
| 57 | Vomiting | 419 | 5.1 | 5.7 | signal |
| 58 | Aphasia | 27 | 5.1 | 5.2 | signal |
| 59 | Dry Throat | 9 | 5.1 | 5.1 | signal |
| 60 | Flushing | 90 | 5.1 | 5.2 | signal |
| 61 | Gingival Bleeding | 12 | 5.0 | 5.1 | signal |
| 62 | Bone Pain | 51 | 5.0 | 5.1 | signal |
| 63 | Angioedema | 38 | 4.9 | 5.0 | signal |
| 64 | Tinnitus | 39 | 4.9 | 4.9 | signal |
| 65 | Urinary Incontinence | 25 | 4.8 | 4.9 | signal |
| 66 | Dysphagia | 79 | 4.8 | 4.9 | signal |
| 67 | Adverse Reaction | 11 | 4.8 | 4.8 | signal |
| 68 | Product Use In Unapproved Indication | 202 | 4.7 | 5.0 | signal |
| 69 | Neuralgia | 20 | 4.7 | 4.8 | signal |
| 70 | Pruritus Generalised | 18 | 4.7 | 4.7 | signal |
| 71 | Tachypnoea | 11 | 4.7 | 4.7 | signal |
| 72 | Wheezing | 48 | 4.7 | 4.7 | signal |
| 73 | Generalised Tonic-clonic Seizure | 13 | 4.6 | 4.6 | signal |
| 74 | Coordination Abnormal | 11 | 4.5 | 4.5 | signal |
| 75 | Ear Discomfort | 8 | 4.5 | 4.5 | signal |
| 76 | Rash Erythematous | 35 | 4.3 | 4.3 | signal |
| 77 | Rash Macular | 26 | 4.3 | 4.3 | signal |
| 78 | Impaired Work Ability | 16 | 4.3 | 4.3 | signal |
| 79 | Blood Urea Increased | 12 | 4.1 | 4.1 | signal |
| 80 | Taste Disorder | 14 | 4.0 | 4.0 | signal |
| 81 | Sleep Disorder | 48 | 3.9 | 4.0 | signal |
| 82 | Quality Of Life Decreased | 9 | 3.8 | 3.9 | signal |
| 83 | Nausea | 523 | 3.8 | 4.3 | signal |
| 84 | Incontinence | 7 | 3.8 | 3.8 | signal |
| 85 | Hyperhidrosis | 85 | 3.8 | 3.9 | signal |
| 86 | Peripheral Coldness | 9 | 3.8 | 3.8 | signal |
| 87 | Haematocrit Decreased | 13 | 3.7 | 3.7 | signal |
| 88 | Joint Stiffness | 17 | 3.7 | 3.7 | signal |
| 89 | Oral Discomfort | 9 | 3.7 | 3.7 | signal |
| 90 | Dermatitis Allergic | 8 | 3.7 | 3.7 | signal |
| 91 | Hypoaesthesia | 96 | 3.7 | 3.8 | signal |
| 92 | Loss Of Consciousness | 82 | 3.7 | 3.7 | signal |
| 93 | Cytokine Release Syndrome | 12 | 3.6 | 3.6 | signal |
| 94 | Syringe Issue | 11 | 3.6 | 3.6 | signal |
| 95 | Restlessness | 23 | 3.6 | 3.6 | signal |
| 96 | Hypertensive Crisis | 7 | 3.6 | 3.6 | signal |
| 97 | Paralysis | 9 | 3.6 | 3.6 | signal |
| 98 | Impaired Quality Of Life | 9 | 3.6 | 3.6 | signal |
| 99 | Chills | 72 | 3.5 | 3.6 | signal |
| 100 | Myalgia | 104 | 3.5 | 3.6 | signal |
| 101 | Eye Irritation | 34 | 3.5 | 3.5 | signal |
| 102 | Rash | 263 | 3.5 | 3.7 | signal |
| 103 | Salivary Hypersecretion | 6 | 3.4 | 3.5 | signal |
| 104 | Hypotonia | 6 | 3.4 | 3.4 | signal |
| 105 | Polyneuropathy | 7 | 3.4 | 3.4 | signal |
| 106 | Hypersensitivity | 109 | 3.4 | 3.5 | signal |
| 107 | Temperature Intolerance | 6 | 3.4 | 3.4 | signal |
| 108 | Blood Sodium Decreased | 11 | 3.4 | 3.4 | signal |
| 109 | Circulatory Collapse | 10 | 3.4 | 3.4 | signal |
| 110 | Tremor | 96 | 3.3 | 3.4 | signal |
| 111 | Blood Pressure Decreased | 38 | 3.3 | 3.3 | signal |
| 112 | Muscular Weakness | 64 | 3.2 | 3.3 | signal |
| 113 | Muscle Atrophy | 7 | 3.2 | 3.2 | signal |
| 114 | Haematuria | 19 | 3.2 | 3.2 | signal |
| 115 | Hyperthyroidism | 8 | 3.2 | 3.2 | signal |
| 116 | Ocular Discomfort | 6 | 3.2 | 3.2 | signal |
| 117 | Menorrhagia | 11 | 3.2 | 3.2 | signal |
| 118 | Conjunctivitis | 10 | 3.1 | 3.1 | signal |
| 119 | Transaminases Increased | 12 | 3.1 | 3.1 | signal |
| 120 | Obstructive Airways Disorder | 6 | 3.1 | 3.1 | signal |
| 121 | Abortion Induced | 5 | 3.0 | 3.0 | signal |
| 122 | Hypotension | 105 | 3.0 | 3.1 | signal |
| 123 | Skin Burning Sensation | 37 | 3.0 | 3.0 | signal |
| 124 | Body Temperature Decreased | 5 | 2.9 | 2.9 | signal |
| 125 | Respiratory Tract Congestion | 8 | 2.9 | 2.9 | signal |
| 126 | Lymphopenia | 7 | 2.9 | 2.9 | signal |
| 127 | Heart Rate Increased | 49 | 2.8 | 2.9 | signal |
| 128 | Restless Legs Syndrome | 9 | 2.8 | 2.8 | signal |
| 129 | Hypothermia | 5 | 2.8 | 2.8 | signal |
| 130 | Hepatic Cytolysis | 6 | 2.8 | 2.8 | signal |
| 131 | Rash Papular | 11 | 2.8 | 2.8 | signal |
| 132 | Visual Impairment | 59 | 2.8 | 2.8 | signal |
| 133 | Proteinuria | 9 | 2.7 | 2.7 | signal |
| 134 | Dry Eye | 23 | 2.7 | 2.7 | signal |
| 135 | Seizure | 54 | 2.7 | 2.7 | signal |
| 136 | Immune System Disorder | 6 | 2.6 | 2.6 | signal |
| 137 | Cardio-respiratory Arrest | 19 | 2.6 | 2.6 | signal |
| 138 | Rash Pruritic | 24 | 2.6 | 2.6 | signal |
| 139 | Metastases To Lung | 5 | 2.5 | 2.5 | no signal |
| 140 | Cardiovascular Disorder | 11 | 2.5 | 2.5 | signal |
| 141 | Vertigo | 26 | 2.4 | 2.5 | signal |
| 142 | Haematoma | 11 | 2.4 | 2.4 | signal |
| 143 | Rash Generalised | 11 | 2.4 | 2.4 | signal |
| 144 | Dysgeusia | 31 | 2.4 | 2.4 | signal |
| 145 | Apathy | 6 | 2.4 | 2.4 | no signal |
| 146 | Heart Rate Irregular | 9 | 2.3 | 2.3 | signal |
| 147 | Toxic Skin Eruption | 4 | 2.3 | 2.3 | no signal |
| 148 | Toothache | 7 | 2.2 | 2.2 | no signal |
| 149 | Agranulocytosis | 7 | 2.2 | 2.2 | no signal |
| 150 | Pain Of Skin | 10 | 2.1 | 2.1 | signal |
| 151 | Drug Level Increased | 6 | 2.1 | 2.1 | no signal |
| 152 | Panic Attack | 13 | 2.0 | 2.0 | signal |
| 153 | Hot Flush | 24 | 1.8 | 1.8 | no signal |
| 154 | Mood Swings | 10 | 1.8 | 1.8 | no signal |
| 155 | Lactic Acidosis | 10 | 1.8 | 1.8 | no signal |
| 156 | Thrombotic Microangiopathy | 3 | 1.8 | 1.8 | no signal |
| 157 | Menstruation Irregular | 8 | 1.7 | 1.7 | no signal |
| 158 | Nephropathy Toxic | 3 | 1.5 | 1.5 | no signal |
| 159 | Metastases To Central Nervous System | 3 | 1.3 | 1.3 | no signal |
| 160 | Premature Delivery | 3 | 1.1 | 1.1 | no signal |
| 161 | No Adverse Event | 33 | 1.1 | 1.1 | no signal |
| 162 | Injection Site Pruritus | 7 | 0.6 | 0.6 | no signal |
| 163 | Incorrect Route Of Drug Administration | 3 | 0.5 | 0.5 | no signal |