OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Glatiramer Acetate Injection

199 flagged reaction(s) · 9,328 total co-reports · max PRR 56.3
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 Multiple Sclerosis 592 56.3 64.3 signal
2 Injection Site Mass 348 43.0 46.4 signal
3 Multiple Sclerosis Relapse 509 33.5 37.5 signal
4 Injection Site Induration 70 24.5 24.9 signal
5 Injection Site Urticaria 128 23.9 24.6 signal
6 Injection Site Swelling 290 17.3 18.4 signal
7 Injection Site Pruritus 244 16.6 17.5 signal
8 Injection Site Warmth 73 16.0 16.3 signal
9 Injection Site Discolouration 42 15.3 15.5 signal
10 Injection Site Erythema 389 14.3 15.5 signal
11 Injection Site Extravasation 37 13.4 13.5 signal
12 Injection Site Irritation 33 11.8 11.9 signal
13 Injection Site Discomfort 25 11.0 11.0 signal
14 Injection Site Reaction 162 10.7 11.0 signal
15 Injection Site Pain 715 10.7 12.4 signal
16 Injection Site Bruising 182 10.4 10.8 signal
17 Device Use Issue 39 10.2 10.3 signal
18 Device Mechanical Issue 29 10.2 10.2 signal
19 Injection Site Nodule 23 9.5 9.5 signal
20 Needle Issue 58 9.2 9.3 signal
21 Central Nervous System Lesion 27 8.8 8.9 signal
22 Product Substitution Issue 94 7.4 7.5 signal
23 Pharyngeal Swelling 15 7.1 7.1 signal
24 Lymphopenia 21 6.7 6.8 signal
25 Injection Site Haemorrhage 118 6.7 6.9 signal
26 Flushing 147 6.5 6.7 signal
27 Hemiparesis 23 6.1 6.1 signal
28 Product Dose Omission 88 6.0 6.1 signal
29 Injection Site Rash 37 5.5 5.5 signal
30 Incorrect Route Of Product Administration 20 5.4 5.4 signal
31 Feeling Hot 72 5.3 5.4 signal
32 Hypoaesthesia 173 5.2 5.4 signal
33 Diplopia 29 5.0 5.1 signal
34 Device Issue 95 4.9 5.0 signal
35 Abortion Induced 10 4.8 4.8 signal
36 Maternal Exposure During Pregnancy 93 4.8 4.8 signal
37 Chills 123 4.7 4.8 signal
38 Paralysis 15 4.7 4.7 signal
39 Anaphylactic Shock 26 4.6 4.6 signal
40 Chest Discomfort 100 4.4 4.5 signal
41 Syringe Issue 17 4.4 4.4 signal
42 Muscle Spasticity 12 4.4 4.4 signal
43 Feeling Cold 26 4.2 4.2 signal
44 Limb Discomfort 28 4.1 4.1 signal
45 Throat Tightness 24 4.0 4.0 signal
46 Scar 15 3.9 4.0 signal
47 Hypoaesthesia Oral 13 3.9 3.9 signal
48 Product Packaging Issue 8 3.9 3.9 signal
49 Skin Reaction 12 3.9 3.9 signal
50 Head Discomfort 15 3.8 3.9 signal
51 Injury Associated With Device 17 3.8 3.8 signal
52 Abortion Spontaneous 34 3.8 3.8 signal
53 Product Use Complaint 13 3.8 3.8 signal
54 Gait Inability 27 3.7 3.7 signal
55 Urinary Incontinence 24 3.7 3.7 signal
56 Insurance Issue 12 3.6 3.7 signal
57 Bladder Disorder 8 3.6 3.6 signal
58 Palpitations 92 3.6 3.6 signal
59 Therapy Interrupted 54 3.5 3.6 signal
60 Gait Disturbance 147 3.5 3.5 signal
61 Kidney Infection 15 3.5 3.5 signal
62 Ataxia 9 3.4 3.4 signal
63 Drug-induced Liver Injury 23 3.4 3.4 signal
64 Device Defective 12 3.3 3.4 signal
65 Device Failure 11 3.3 3.3 signal
66 Muscular Weakness 81 3.2 3.3 signal
67 Balance Disorder 61 3.2 3.2 signal
68 Paraesthesia 110 3.1 3.2 signal
69 Anaphylactic Reaction 38 3.1 3.1 signal
70 Muscle Tightness 11 3.1 3.1 signal
71 Product Dose Omission Issue 193 3.1 3.1 signal
72 Malignant Melanoma 9 3.0 3.0 signal
73 Clostridium Difficile Colitis 7 3.0 3.0 signal
74 Loss Of Consciousness 81 2.9 2.9 signal
75 Cystitis 20 2.8 2.8 signal
76 Tremor 103 2.8 2.8 signal
77 Neuralgia 15 2.8 2.8 signal
78 Micturition Urgency 7 2.8 2.8 signal
79 Speech Disorder 32 2.8 2.8 signal
80 Hepatomegaly 6 2.7 2.7 signal
81 Urticaria 101 2.7 2.8 signal
82 Therapy Cessation 31 2.7 2.8 signal
83 Adverse Reaction 8 2.7 2.7 signal
84 Hypotonia 6 2.7 2.7 signal
85 Aphasia 18 2.7 2.7 signal
86 Body Temperature Increased 12 2.6 2.7 signal
87 Ear Discomfort 6 2.6 2.6 signal
88 Ankle Fracture 9 2.6 2.6 signal
89 Wrong Technique In Product Usage Process 117 2.6 2.7 signal
90 Oral Pain 13 2.6 2.6 signal
91 Panic Attack 21 2.6 2.6 signal
92 Post Procedural Complication 11 2.6 2.6 signal
93 Mouth Ulceration 12 2.6 2.6 signal
94 Visual Impairment 69 2.5 2.6 signal
95 Cognitive Disorder 26 2.5 2.5 signal
96 Hospitalisation 85 2.5 2.5 signal
97 Chest Pain 103 2.5 2.5 signal
98 Urinary Tract Infection 93 2.5 2.5 signal
99 Dysstasia 16 2.5 2.5 signal
100 Brain Neoplasm 5 2.5 2.5 no signal
101 Pregnancy 11 2.5 2.5 signal
102 Heart Rate Increased 53 2.4 2.4 signal
103 Burning Sensation 37 2.4 2.4 signal
104 Swelling Face 34 2.4 2.4 signal
105 Vasculitis 6 2.3 2.3 no signal
106 Spinal Pain 6 2.3 2.3 no signal
107 Incorrect Dose Administered By Device 13 2.3 2.3 signal
108 Cold Sweat 9 2.3 2.3 signal
109 Syncope 51 2.3 2.3 signal
110 Inability To Afford Medication 5 2.3 2.3 no signal
111 Head Injury 16 2.3 2.3 signal
112 Seizure 58 2.3 2.3 signal
113 Covid-19 89 2.3 2.3 signal
114 Mass 7 2.3 2.3 no signal
115 Coordination Abnormal 7 2.2 2.3 no signal
116 Device Leakage 21 2.2 2.2 signal
117 Presyncope 12 2.2 2.2 signal
118 Motor Dysfunction 5 2.2 2.2 no signal
119 Temperature Intolerance 5 2.2 2.2 no signal
120 Fall 162 2.2 2.2 signal
121 Paraesthesia Oral 7 2.2 2.2 no signal
122 Influenza Like Illness 40 2.2 2.2 signal
123 Lymphadenopathy 17 2.2 2.2 signal
124 Injection Site Haematoma 7 2.2 2.2 no signal
125 Renal Pain 5 2.1 2.1 no signal
126 Movement Disorder 15 2.1 2.1 signal
127 Oral Herpes 9 2.1 2.1 signal
128 Ocular Discomfort 5 2.1 2.1 no signal
129 Product Quality Issue 62 2.1 2.1 signal
130 Device Difficult To Use 30 2.0 2.1 signal
131 Muscle Spasms 83 2.0 2.1 signal
132 Lymphoma 7 2.0 2.0 no signal
133 Hot Flush 34 2.0 2.0 signal
134 Therapeutic Product Effect Decreased 20 2.0 2.0 signal
135 Nerve Injury 5 2.0 2.0 no signal
136 Adverse Drug Reaction 40 2.0 2.0 signal
137 Cyanosis 7 2.0 2.0 no signal
138 Blindness 18 2.0 2.0 no signal
139 Hyperhidrosis 57 2.0 2.0 no signal
140 Status Epilepticus 5 2.0 2.0 no signal
141 Sensory Disturbance 7 2.0 2.0 no signal
142 Muscle Twitching 10 2.0 2.0 no signal
143 Memory Impairment 59 1.9 1.9 no signal
144 Incorrect Dose Administered 96 1.9 1.9 no signal
145 Blindness Unilateral 6 1.9 1.9 no signal
146 Caesarean Section 5 1.9 1.9 no signal
147 Covid-19 Pneumonia 5 1.9 1.9 no signal
148 Accident 5 1.9 1.9 no signal
149 Macular Degeneration 5 1.9 1.9 no signal
150 Hypokinesia 6 1.9 1.9 no signal
151 Underdose 30 1.9 1.9 no signal
152 Pruritus Generalised 9 1.9 1.9 no signal
153 Jaundice 11 1.8 1.8 no signal
154 Device Breakage 16 1.8 1.8 no signal
155 Cyst 5 1.8 1.8 no signal
156 Pneumocystis Jirovecii Pneumonia 4 1.8 1.8 no signal
157 Ovarian Cyst 4 1.8 1.8 no signal
158 Feeling Abnormal 95 1.8 1.8 no signal
159 Herpes Zoster 22 1.7 1.7 no signal
160 Skin Cancer 8 1.7 1.7 no signal
161 Mental Impairment 9 1.7 1.7 no signal
162 Generalised Tonic-clonic Seizure 6 1.7 1.7 no signal
163 Musculoskeletal Disorder 7 1.7 1.7 no signal
164 Cerebral Haemorrhage 13 1.6 1.6 no signal
165 Hyperthyroidism 5 1.6 1.6 no signal
166 Incorrect Product Administration Duration 7 1.6 1.6 no signal
167 Neoplasm Malignant 23 1.6 1.6 no signal
168 Product Prescribing Issue 7 1.6 1.6 no signal
169 Knee Arthroplasty 7 1.5 1.5 no signal
170 Product Dose Omission In Error 9 1.5 1.5 no signal
171 Spinal Operation 4 1.5 1.5 no signal
172 Thyroid Cancer 4 1.5 1.5 no signal
173 Foetal Exposure During Pregnancy 26 1.4 1.4 no signal
174 Increased Appetite 6 1.4 1.4 no signal
175 Premature Delivery 5 1.4 1.4 no signal
176 Decreased Immune Responsiveness 3 1.4 1.4 no signal
177 Inflammatory Bowel Disease 3 1.4 1.4 no signal
178 Drug Exposure During Pregnancy 10 1.3 1.3 no signal
179 Drug Effect Less Than Expected 4 1.3 1.3 no signal
180 Skin Irritation 13 1.3 1.3 no signal
181 Device Malfunction 19 1.3 1.3 no signal
182 Product Dispensing Error 6 1.2 1.2 no signal
183 Product Administered At Inappropriate Site 5 1.2 1.2 no signal
184 Product Availability Issue 6 1.2 1.2 no signal
185 Product Storage Error 20 1.0 1.0 no signal
186 Device Delivery System Issue 6 1.0 1.0 no signal
187 Dysmenorrhoea 3 1.0 1.0 no signal
188 Colitis Ulcerative 10 1.0 1.0 no signal
189 Menorrhagia 4 0.9 0.9 no signal
190 Wrong Technique In Device Usage Process 9 0.9 0.9 no signal
191 Amenorrhoea 3 0.8 0.8 no signal
192 Circumstance Or Information Capable Of Leading To Medication Error 6 0.8 0.8 no signal
193 Accidental Exposure To Product 17 0.8 0.8 no signal
194 Breast Cancer 15 0.7 0.7 no signal
195 Device Use Error 4 0.5 0.5 no signal
196 Menstruation Irregular 3 0.5 0.5 no signal
197 Incorrect Route Of Drug Administration 4 0.5 0.5 no signal
198 Drug Dose Omission By Device 8 0.5 0.5 no signal
199 Renal Cancer 3 0.3 0.3 no signal