SEROPRAM

Seropram Adverse Events Reported to the FDA Over Time

How are Seropram adverse event reports trending over time?

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

Most Common Seropram Adverse Events Reported to the FDA

What are the most common Seropram adverse events reported to the FDA?

Drug Exposure During Pregnancy	38 (3%)
Drug Interaction	36 (2.85%)
Fall	24 (1.9%)
Hyponatraemia	24 (1.9%)
Malaise	20 (1.58%)
Premature Baby	14 (1.11%)
Confusional State	13 (1.03%)
Depression	13 (1.03%)
Agitation	11 (.87%)
Cytolytic Hepatitis	11 (.87%)
Disorientation	11 (.87%)
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International Normalised Ratio Incr...	11 (.87%)
Loss Of Consciousness	11 (.87%)
Condition Aggravated	10 (.79%)
Renal Failure Acute	10 (.79%)
Serotonin Syndrome	10 (.79%)
Somnolence	10 (.79%)
Agranulocytosis	9 (.71%)
Coma	9 (.71%)
Hyperkalaemia	9 (.71%)
Overdose	9 (.71%)
Tremor	9 (.71%)
Abdominal Pain	8 (.63%)
Anaemia	8 (.63%)
Atrial Septal Defect	8 (.63%)
Congenital Musculoskeletal Anomaly	8 (.63%)
Dyskinesia	8 (.63%)
Suicide Attempt	8 (.63%)
Asthenia	7 (.55%)
Cerebrovascular Accident	7 (.55%)
Cholestasis	7 (.55%)
Depressed Level Of Consciousness	7 (.55%)
Haemoglobin Decreased	7 (.55%)
Hypertension	7 (.55%)
Vomiting	7 (.55%)
Anxiety	6 (.47%)
Diplopia	6 (.47%)
Disturbance In Attention	6 (.47%)
Drug Ineffective	6 (.47%)
Gamma-glutamyltransferase Increased	6 (.47%)
General Physical Health Deteriorati...	6 (.47%)
Head Injury	6 (.47%)
Hemianopia	6 (.47%)
Hepatitis Fulminant	6 (.47%)
Hypercholesterolaemia	6 (.47%)
Hypotension	6 (.47%)
Leukopenia	6 (.47%)
Neutropenia	6 (.47%)
Pyrexia	6 (.47%)
Renal Failure	6 (.47%)
Renal Impairment	6 (.47%)
Respiratory Failure	6 (.47%)
Sepsis	6 (.47%)
Abnormal Behaviour	5 (.4%)
Caesarean Section	5 (.4%)
Cerebral Haemorrhage	5 (.4%)
Cervical Root Pain	5 (.4%)
Dehydration	5 (.4%)
Drug Toxicity	5 (.4%)
Electrocardiogram Qt Prolonged	5 (.4%)
Eyelid Ptosis	5 (.4%)
Haematoma	5 (.4%)
Lactic Acidosis	5 (.4%)
Muscle Rigidity	5 (.4%)
Musculoskeletal Pain	5 (.4%)
Pregnancy	5 (.4%)
Speech Disorder	5 (.4%)
Stomatitis	5 (.4%)
Urinary Retention	5 (.4%)
Vertigo	5 (.4%)
White Blood Cell Count Increased	5 (.4%)
Abortion Induced	4 (.32%)
Blood Chloride Decreased	4 (.32%)
Cardiac Failure	4 (.32%)
Coordination Abnormal	4 (.32%)
Dermatosis	4 (.32%)
Diarrhoea	4 (.32%)
Dizziness	4 (.32%)
Dry Skin	4 (.32%)
Dysphagia	4 (.32%)
Extrapyramidal Disorder	4 (.32%)
Gastric Ulcer Perforation	4 (.32%)
Genital Erythema	4 (.32%)
Jaundice	4 (.32%)
Orthostatic Hypotension	4 (.32%)
Peritonitis	4 (.32%)
Platelet Count Increased	4 (.32%)
Polyhydramnios	4 (.32%)
Renal Cyst	4 (.32%)
Skin Burning Sensation	4 (.32%)
Skin Infection	4 (.32%)
Tachycardia	4 (.32%)
Thrombocytopenia	4 (.32%)
Abortion Spontaneous	3 (.24%)
Agitation Neonatal	3 (.24%)
Anorexia	3 (.24%)
Apgar Score Low	3 (.24%)
Aphasia	3 (.24%)
Blood Creatine Phosphokinase Increa...	3 (.24%)
Blood Pressure Systolic Increased	3 (.24%)
Blood Sodium Decreased	3 (.24%)

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This graph shows the top adverse events submitted to the FDA for Seropram, 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 Seropram 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 Seropram

What are the most common Seropram adverse events reported to the FDA?

Neurological	83 (6.56%)
Chemical Injury And Poisoning	47 (3.72%)
Therapeutic And Nontherapeutic Effe...	46 (3.64%)
Hepatic And Hepatobiliary	45 (3.56%)
Hematology Investigations	44 (3.48%)
Electrolyte And Fluid Balance Condi...	40 (3.16%)
Injuries	38 (3%)
Infections - Pathogen Unspecified	32 (2.53%)
Renal Disorders	29 (2.29%)
Movement Disorders	28 (2.21%)
Epidermal And Dermal Conditions	27 (2.13%)
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Deliria	26 (2.06%)
Gastrointestinal Signs	25 (1.98%)
Central Nervous System Vascular	24 (1.9%)
White Blood Cell	23 (1.82%)
Cardiac And Vascular Investigations	21 (1.66%)
Anxiety Disorders	20 (1.58%)
Respiratory	18 (1.42%)
Hepatobiliary	17 (1.34%)
Medication Errors	16 (1.26%)
Neonatal And Perinatal Conditions	16 (1.26%)
Depressed Mood Disorders	15 (1.19%)
Musculoskeletal And Connective Tiss...	15 (1.19%)
Neuromuscular	15 (1.19%)
Cardiac Arrhythmias	14 (1.11%)
Anemias Nonhemolytic And Marrow Dep...	13 (1.03%)
Water, Electrolyte And Mineral	13 (1.03%)
Decreased And Nonspecific Blood Pre...	12 (.95%)
Disturbances In Thinking	12 (.95%)
Mental Impairment	12 (.95%)
Musculoskeletal And Connective Tiss...	11 (.87%)
Oral Soft Tissue Conditions	11 (.87%)
Peritoneal And Retroperitoneal Cond...	11 (.87%)
Seizures	10 (.79%)
Body Temperature Conditions	9 (.71%)
Muscle	9 (.71%)
Obstetric And Gynecological Therape...	9 (.71%)
Ocular Neuromuscular	9 (.71%)
Suicidal And Self-injurious Behavio...	9 (.71%)
Urinary Tract Signs	9 (.71%)
Vision	9 (.71%)
Acid-base	8 (.63%)
Cardiac And Vascular Disorders Cong...	8 (.63%)
Embolism And Thrombosis	8 (.63%)
Myocardial	8 (.63%)
Placental, Amniotic And Cavity Diso...	8 (.63%)
Skin Vascular Abnormalities	7 (.55%)
Vascular Hypertensive	7 (.55%)
Fetal Complications	6 (.47%)
Inner Ear And Viiith Cranial Nerve	6 (.47%)
Lipid Metabolism	6 (.47%)
Maternal Complications Of Labour An...	6 (.47%)
Metabolic, Nutritional And Blood Ga...	6 (.47%)
Neurological Disorders Of The Eye	6 (.47%)
Neurological, Special Senses And Ps...	6 (.47%)
Pregnancy, Labour, Delivery And Pos...	6 (.47%)
Reproductive Tract	6 (.47%)
Vascular Hemorrhagic	6 (.47%)
Abortions And Stillbirth	5 (.4%)
Appetite And General Nutritional	5 (.4%)
Enzyme	5 (.4%)
Gastrointestinal Motility And Defec...	5 (.4%)
Menstrual Cycle And Uterine Bleedin...	5 (.4%)
Physical Examination Topics	5 (.4%)
Psychiatric And Behavioural Symptom...	5 (.4%)
Renal And Urinary Tract Disorders C...	5 (.4%)
Renal And Urinary Tract Investigati...	5 (.4%)
Spinal Cord And Nerve Root	5 (.4%)
Toxicology And Therapeutic Drug Mon...	5 (.4%)
Encephalopathies	4 (.32%)
Gastrointestinal Ulceration And Per...	4 (.32%)
Heart Failures	4 (.32%)
Lower Respiratory Tract Disorders	4 (.32%)
Mood Disorders	4 (.32%)
Peripheral Neuropathies	4 (.32%)
Platelet	4 (.32%)
Bacterial Infectious	3 (.24%)
Bile Duct	3 (.24%)
Bone And Joint Injuries	3 (.24%)
Congenital And Hereditary	3 (.24%)
Fungal Infectious	3 (.24%)
Gastrointestinal	3 (.24%)
Gastrointestinal Hemorrhages	3 (.24%)
Glucose Metabolism Disorders	3 (.24%)
Headaches	3 (.24%)
Hemolyses And Related Conditions	3 (.24%)
Hepatobiliary Therapeutic Procedure...	3 (.24%)
Increased Intracranial Pressure And...	3 (.24%)
Lifestyle Issues	3 (.24%)
Microbiology And Serology	3 (.24%)
Neonatal Respiratory	3 (.24%)
Ocular Hemorrhages And Vascular	3 (.24%)
Personality Disorders	3 (.24%)
Procedural And Device Related Injur...	3 (.24%)
Skin And Subcutaneous Tissue	3 (.24%)
Therapeutic Procedures And Supporti...	3 (.24%)
Vascular	3 (.24%)
Allergic Conditions	2 (.16%)
Arteriosclerosis, Stenosis, Vascula...	2 (.16%)
Bronchial Disorders	2 (.16%)
Cardiac Valve	2 (.16%)

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This graph shows the top categories of adverse events submitted to the FDA for Seropram, 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 Seropram 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.