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Drug

Gadoterate Meglumine

163 flagged reaction(s) · 8,625 total co-reports · max PRR 33.6
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