IMMUNE GLOBULIN

Immune Globulin Adverse Events Reported to the FDA Over Time

How are Immune Globulin adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Immune Globulin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Immune Globulin is flagged as the suspect drug causing the adverse event.

Most Common Immune Globulin Adverse Events Reported to the FDA

What are the most common Immune Globulin adverse events reported to the FDA?

Pyrexia	161 (1.91%)
Drug Exposure During Pregnancy	159 (1.89%)
Neutropenia	131 (1.55%)
Haemoglobin Decreased	126 (1.5%)
Headache	113 (1.34%)
Purpura	103 (1.22%)
Rash Maculo-papular	101 (1.2%)
Chills	97 (1.15%)
Nausea	96 (1.14%)
Rash Erythematous	96 (1.14%)
Rectal Haemorrhage	96 (1.14%)
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Vaginal Haemorrhage	96 (1.14%)
Melaena	92 (1.09%)
Drug Ineffective	91 (1.08%)
Vomiting	82 (.97%)
Infusion Related Reaction	76 (.9%)
Arthralgia	69 (.82%)
Haemorrhage	64 (.76%)
Haemolytic Anaemia	61 (.72%)
Adverse Event	58 (.69%)
Dyspnoea	57 (.68%)
Rash	56 (.66%)
Convulsion	54 (.64%)
Renal Failure Acute	50 (.59%)
Haemorrhage Intracranial	49 (.58%)
Metal Poisoning	49 (.58%)
Hypertension	45 (.53%)
Hypotension	45 (.53%)
Tachycardia	45 (.53%)
Pulmonary Embolism	44 (.52%)
Neurotoxicity	43 (.51%)
Thrombocytopenia	41 (.49%)
Cerebrovascular Accident	37 (.44%)
Asthenia	35 (.42%)
Abortion Spontaneous	34 (.4%)
Blood Pressure Increased	34 (.4%)
Acute Respiratory Distress Syndrome	33 (.39%)
Condition Aggravated	33 (.39%)
Renal Failure	33 (.39%)
Respiratory Failure	33 (.39%)
Chest Pain	32 (.38%)
Diarrhoea	32 (.38%)
Pneumonia	32 (.38%)
Pulmonary Hypertension	32 (.38%)
Meningitis Aseptic	31 (.37%)
Oxygen Saturation Decreased	31 (.37%)
Cough	30 (.36%)
Haemolysis	30 (.36%)
Malaise	30 (.36%)
Off Label Use	30 (.36%)
Anaphylactic Reaction	29 (.34%)
Sepsis	29 (.34%)
Tremor	29 (.34%)
Multi-organ Failure	28 (.33%)
Toxic Epidermal Necrolysis	28 (.33%)
Back Pain	27 (.32%)
Depressed Level Of Consciousness	27 (.32%)
Dizziness	27 (.32%)
Fatigue	27 (.32%)
Hypersensitivity	27 (.32%)
Respiratory Disorder	27 (.32%)
Anaphylactoid Reaction	25 (.3%)
Heart Rate Increased	25 (.3%)
Hyperhidrosis	25 (.3%)
Pruritus	25 (.3%)
Abdominal Pain	24 (.28%)
Blood Creatinine Increased	24 (.28%)
Deep Vein Thrombosis	24 (.28%)
Hypoglycaemia	24 (.28%)
Tricuspid Valve Incompetence	24 (.28%)
Urinary Tract Infection	24 (.28%)
Feeling Abnormal	23 (.27%)
Premature Baby	23 (.27%)
Urticaria	23 (.27%)
Cytomegalovirus Infection	22 (.26%)
Dilatation Ventricular	22 (.26%)
No Therapeutic Response	22 (.26%)
Premature Labour	22 (.26%)
Blood Blister	21 (.25%)
Haematocrit Decreased	21 (.25%)
Idiopathic Thrombocytopenic Purpura	21 (.25%)
Cerebral Infarction	20 (.24%)
Drug Intolerance	20 (.24%)
Lymphoproliferative Disorder	20 (.24%)
Bacteraemia	19 (.23%)
Cardiac Failure	19 (.23%)
Pancytopenia	19 (.23%)
Staphylococcal Infection	19 (.23%)
Bacterial Infection	18 (.21%)
Confusional State	18 (.21%)
Myocardial Infarction	18 (.21%)
Peritonitis	18 (.21%)
Photophobia	18 (.21%)
Red Blood Cell Count Decreased	18 (.21%)
Anaemia	17 (.2%)
Blood Pressure Decreased	17 (.2%)
Caesarean Section	17 (.2%)
Disseminated Intravascular Coagulat...	17 (.2%)
Encephalopathy	17 (.2%)
Herpes Zoster	17 (.2%)
Loss Of Consciousness	17 (.2%)

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This graph shows the top adverse events submitted to the FDA for Immune Globulin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Immune Globulin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Immune Globulin

What are the most common Immune Globulin adverse events reported to the FDA?

Epidermal And Dermal Conditions	494 (5.86%)
Infections - Pathogen Unspecified	284 (3.37%)
Neurological	279 (3.31%)
Hematology Investigations	278 (3.3%)
Respiratory	273 (3.24%)
Chemical Injury And Poisoning	239 (2.84%)
Therapeutic And Nontherapeutic Effe...	231 (2.74%)
Gastrointestinal Signs	230 (2.73%)
Gastrointestinal Hemorrhages	199 (2.36%)
Viral Infectious	197 (2.34%)
Central Nervous System Vascular	192 (2.28%)
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Body Temperature Conditions	167 (1.98%)
White Blood Cell	166 (1.97%)
Bacterial Infectious	128 (1.52%)
Renal Disorders	128 (1.52%)
Skin Vascular Abnormalities	124 (1.47%)
Headaches	121 (1.44%)
Cardiac And Vascular Investigations	120 (1.42%)
Allergic Conditions	118 (1.4%)
Administration Site Reactions	110 (1.31%)
Hemolyses And Related Conditions	110 (1.31%)
Cardiac Arrhythmias	106 (1.26%)
Joint	101 (1.2%)
Vulvovaginal Disorders	96 (1.14%)
Microbiology And Serology	95 (1.13%)
Lower Respiratory Tract Disorders	85 (1.01%)
Pulmonary Vascular	80 (.95%)
Musculoskeletal And Connective Tiss...	78 (.93%)
Decreased And Nonspecific Blood Pre...	70 (.83%)
Platelet	70 (.83%)
Movement Disorders	69 (.82%)
Hepatic And Hepatobiliary	68 (.81%)
Vascular Hemorrhagic	67 (.8%)
Seizures	64 (.76%)
Embolism And Thrombosis	62 (.74%)
Vision	62 (.74%)
Abortions And Stillbirth	61 (.72%)
Myocardial	61 (.72%)
Procedural And Device Related Injur...	59 (.7%)
Coronary Artery	58 (.69%)
Renal And Urinary Tract Investigati...	58 (.69%)
Metabolic, Nutritional And Blood Ga...	57 (.68%)
Physical Examination Topics	57 (.68%)
Hepatobiliary	55 (.65%)
Encephalopathies	54 (.64%)
Anemias Nonhemolytic And Marrow Dep...	48 (.57%)
Glucose Metabolism Disorders	48 (.57%)
Vascular Hypertensive	47 (.56%)
Medication Errors	46 (.55%)
Skin Appendage Conditions	45 (.53%)
Immune	42 (.5%)
Hematological And Lymphoid Tissue T...	41 (.49%)
Fungal Infectious	39 (.46%)
Hematopoietic Neoplasms	39 (.46%)
Therapeutic Procedures And Supporti...	39 (.46%)
Vascular	39 (.46%)
Fatal Outcomes	37 (.44%)
Injuries	37 (.44%)
Angiedema And Urticaria	36 (.43%)
Gastrointestinal Motility And Defec...	36 (.43%)
Urinary Tract Signs	35 (.42%)
Cardiac Valve	34 (.4%)
Deliria	34 (.4%)
Electrolyte And Fluid Balance Condi...	34 (.4%)
Upper Respiratory Tract Disorders	34 (.4%)
Anxiety Disorders	32 (.38%)
Coagulopathies And Bleeding Diathes...	32 (.38%)
Heart Failures	32 (.38%)
Peritoneal And Retroperitoneal Cond...	32 (.38%)
Appetite And General Nutritional	31 (.37%)
Enzyme	30 (.36%)
Maternal Complications Of Labour An...	30 (.36%)
Muscle	30 (.36%)
Obstetric And Gynecological Therape...	30 (.36%)
Ocular Infections, Irritations And ...	28 (.33%)
Protein And Chemistry Analyses	27 (.32%)
Tongue Conditions	27 (.32%)
Arteriosclerosis, Stenosis, Vascula...	26 (.31%)
Neonatal And Perinatal Conditions	26 (.31%)
Nephropathies	26 (.31%)
Tissue	24 (.28%)
Water, Electrolyte And Mineral	24 (.28%)
Peripheral Neuropathies	23 (.27%)
Ancillary Infectious Topics	22 (.26%)
Bronchial Disorders	21 (.25%)
Ocular Sensory Symptoms	20 (.24%)
Ocular Structural Change, Deposit A...	20 (.24%)
Retina, Choroid And Vitreous Hemorr...	20 (.24%)
Gastrointestinal Ulceration And Per...	19 (.23%)
Neuromuscular	19 (.23%)
Spleen, Lymphatic And Reticulendoth...	19 (.23%)
Cardiac Disorder Signs	17 (.2%)
Mental Impairment	17 (.2%)
Pleural	17 (.2%)
Oral Soft Tissue Conditions	16 (.19%)
Immunodeficiency Syndromes	15 (.18%)
Leukemias	15 (.18%)
Lipid Analyses	15 (.18%)
Product Quality Issues	15 (.18%)
Ocular Neuromuscular	14 (.17%)
Vascular Inflammations	14 (.17%)

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This graph shows the top categories of adverse events submitted to the FDA for Immune Globulin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Immune Globulin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.