milnacipran


EMA27



General information:


Withdrawn ID: EMA27
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): N06AX17
Molecular Formula: C15H22N2O
Molweight: 246.354



Withdrawal information:


Withdrawn due to drug safety reasons:No



Side-effects:

Total reported cases (submitted by medical professionals) with milnacipran as primary suspect: 1184


Reported final outcomes:
Hospitalization (initial or prolonged): 168
Intervention required to prevent permanent impairment/damage: 59
Death: 25
Life-Threatening condition: 18
Disability: 13


Reported side-effects:

Side-effect Case number
NAUSEA144
HEADACHE80
SUICIDAL IDEATION75
HYPERHIDROSIS63
VOMITING58
BLOOD PRESSURE INCREASED53
RASH47
INSOMNIA44
DIZZINESS40
HOT FLUSH39
HYPERTENSION37
DEPRESSION37
TACHYCARDIA36
PALPITATIONS36
TREMOR33
SEROTONIN SYNDROME33
ANXIETY33
PAIN32
HEART RATE INCREASED30
URINARY RETENTION29
FEELING ABNORMAL29
OFF LABEL USE27
CHEST PAIN27
DYSPNOEA25
FATIGUE23
DRUG HYPERSENSITIVITY22
CRYING22
ANGER22
AGITATION22
VISION BLURRED19
HYPERSENSITIVITY19
IRRITABILITY18
MALAISE17
DRUG INEFFECTIVE17
CONFUSIONAL STATE17
ABDOMINAL PAIN17
MIGRAINE16
CONSTIPATION16
HALLUCINATION15
FLUSHING15
SUICIDE ATTEMPT14
PRURITUS14
DYSURIA14
WEIGHT INCREASED13
DRUG INTERACTION13
DIARRHOEA13
DECREASED APPETITE13
PARAESTHESIA12
NIGHTMARE12
ASTHENIA12
PYREXIA11
CONVULSION11
AGGRESSION11
WEIGHT DECREASED10
VERTIGO10
URTICARIA10
SOMNOLENCE10
SINUS TACHYCARDIA10
CHILLS10
ALOPECIA10
OVERDOSE9
HYPOAESTHESIA9
DEATH9
SYNCOPE8
RHABDOMYOLYSIS8
PANIC ATTACK8
OEDEMA PERIPHERAL8
NIGHT SWEATS8
MYOCARDIAL INFARCTION8
MUSCLE SPASMS8
LIP SWELLING8
HOMICIDAL IDEATION8
HEPATIC ENZYME INCREASED8
FEELING JITTERY8
CONDITION AGGRAVATED8
COMPLETED SUICIDE8
CHEST DISCOMFORT8
BLOOD GLUCOSE INCREASED8
NERVOUSNESS7
LIBIDO DECREASED7
HYPERTENSIVE CRISIS7
DEHYDRATION7
AMNESIA7
ADVERSE EVENT7
URINARY HESITATION6
TESTICULAR PAIN6
SWELLING FACE6
SLEEP DISORDER6
PARANOIA6
LOSS OF CONSCIOUSNESS6
DRY MOUTH6
ABDOMINAL PAIN UPPER6
URINARY TRACT INFECTION5
TARDIVE DYSKINESIA5
STEVENS-JOHNSON SYNDROME5
RESTLESSNESS5
RASH MACULO-PAPULAR5
NECK PAIN5
MUSCULOSKELETAL STIFFNESS5
MOOD SWINGS5
MENTAL STATUS CHANGES5
MEMORY IMPAIRMENT5
INFLUENZA LIKE ILLNESS5
HYPOTENSION5
FOOD ALLERGY5
FIBROMYALGIA5
FALL5
ELECTROCARDIOGRAM QT PROLONGED5
DISTURBANCE IN ATTENTION5
DEPRESSIVE SYMPTOM5
CARDIOMYOPATHY5
BLISTER5
ASPARTATE AMINOTRANSFERASE INCREASED5
ARTHRALGIA5
ARRHYTHMIA5
ALANINE AMINOTRANSFERASE INCREASED5
ADVERSE DRUG REACTION5
ABNORMAL DREAMS5
RASH PAPULAR4
RASH GENERALISED4
PHARYNGEAL OEDEMA4
PANCREATITIS ACUTE4
PAIN IN EXTREMITY4
OROPHARYNGEAL PAIN4
MYALGIA4
MOOD ALTERED4
LIVER FUNCTION TEST ABNORMAL4
INTERNATIONAL NORMALISED RATIO INCREASED4
HYPONATRAEMIA4
HYPOMANIA4
GRAND MAL CONVULSION4
ERYTHEMA4
CONTUSION4
CARDIAC FAILURE CONGESTIVE4
BLOOD SODIUM DECREASED4
BIPOLAR DISORDER4
ABDOMINAL DISCOMFORT4
WHITE BLOOD CELL COUNT DECREASED3
VAGINAL HAEMORRHAGE3
UNEVALUABLE EVENT3
THROAT TIGHTNESS3
SWELLING3
STATUS ASTHMATICUS3
SPEECH DISORDER3
ROAD TRAFFIC ACCIDENT3
RENAL FAILURE ACUTE3
RENAL FAILURE3
PULMONARY OEDEMA3
PULMONARY EMBOLISM3
PSYCHOTIC DISORDER3
Prescribed overdose3
Pneumonia3
PLEURAL EFFUSION3
Peripheral swelling3
PAROSMIA3
PARAESTHESIA ORAL3
ORGASM ABNORMAL3
OEDEMA3
NOREPINEPHRINE INCREASED3
MYDRIASIS3
MUSCLE RIGIDITY3
MULTIPLE DRUG OVERDOSE INTENTIONAL3
MITRAL VALVE INCOMPETENCE3
MICTURITION DISORDER3
MEDICATION ERROR3
MANIA3
Intentional overdose3
IMPAIRED WORK ABILITY3
HYPOGLYCAEMIA3
HEPATOTOXICITY3
HAEMATOMA3
GINGIVAL BLEEDING3
GASTROOESOPHAGEAL REFLUX DISEASE3
FAECES DISCOLOURED3
EMOTIONAL DISORDER3
DYSPHAGIA3
DYSGEUSIA3
DRUG SCREEN POSITIVE3
Drug intolerance3
Drug dose omission3
CHROMATURIA3
CEREBROVASCULAR ACCIDENT3
CEREBRAL HAEMORRHAGE3
Cardiac disorder3
BURNING SENSATION3
BLOOD CATECHOLAMINES INCREASED3
BLOOD ALKALINE PHOSPHATASE INCREASED3
BACK PAIN3
ATRIAL FIBRILLATION3
ANGIOEDEMA3
ANGINA PECTORIS3
AFFECT LABILITY3
ABNORMAL BEHAVIOUR3
Wrong technique in product usage process2
VIRAL INFECTION2
VENTRICULAR HYPOKINESIA2
URINE ODOUR ABNORMAL2
URINE FLOW DECREASED2
URINARY INCONTINENCE2
UPPER RESPIRATORY TRACT INFECTION2
TINNITUS2
THINKING ABNORMAL2
THERMAL BURN2
TENSION2
SUSPICIOUSNESS2
SKIN EXFOLIATION2
SEDATION2
RETCHING2
RENAL PAIN2
RECTAL HAEMORRHAGE2
RASH PRURITIC2
QUALITY OF LIFE DECREASED2
PSYCHOMOTOR HYPERACTIVITY2
PROSTATITIS2
PROSTATIC DISORDER2
Product dose omission2
PREGNANCY2
POOR QUALITY SLEEP2
POLLAKIURIA2
Pneumonia aspiration2
PHOTOSENSITIVITY REACTION2
ORTHOSTATIC HYPOTENSION2
ORTHOPNOEA2
NO THERAPEUTIC RESPONSE2
NEUROLEPTIC MALIGNANT SYNDROME2
MUSCULOSKELETAL PAIN2
MUSCULOSKELETAL DISCOMFORT2
MOVEMENT DISORDER2
MOUTH ULCERATION2
MICTURITION URGENCY2
MENTAL DISORDER2
MENSTRUAL DISORDER2
LUNG DISORDER2
LOW DENSITY LIPOPROTEIN INCREASED2
Intestinal obstruction2
IMPULSIVE BEHAVIOUR2
IMPAIRED DRIVING ABILITY2
ILL-DEFINED DISORDER2
HYPOAESTHESIA ORAL2
Hyperprolactinaemia2
HEPATITIS ACUTE2
HEPATITIS2
HEPATIC STEATOSIS2
HELLP SYNDROME2
HAEMORRHAGE2
GROIN PAIN2
GLAUCOMA2
GASTROINTESTINAL HAEMORRHAGE2
GASTROINTESTINAL DISORDER2
FRUSTRATION2
FLATULENCE2
FEELING HOT2
FAECALOMA2
EYE SWELLING2
ERECTILE DYSFUNCTION2
EPISTAXIS2
EJACULATION DISORDER2
DYSTONIA2
DYSPNOEA EXERTIONAL2
DYSPEPSIA2
DYSKINESIA2
DRUG PRESCRIBING ERROR2
DRUG ABUSE2
DIASTOLIC DYSFUNCTION2
Depressed level of consciousness2
DELUSION2
CYANOSIS2
CONGESTIVE CARDIOMYOPATHY2
COLD SWEAT2
COGNITIVE DISORDER2
CARDIOMEGALY2
BRUXISM2
BRADYCARDIA2
BLOOD PRESSURE SYSTOLIC INCREASED2
BLOOD CALCIUM DECREASED2
BLOOD ALBUMIN DECREASED2
BLINDNESS2
BLEPHAROSPASM2
APHASIA2
Anaemia2
AMENORRHOEA2
ACUTE HEPATIC FAILURE2
ACUTE CORONARY SYNDROME2
WRONG DRUG ADMINISTERED1
Wound infection staphylococcal1
WITHDRAWAL SYNDROME1
White blood cell disorder1
WHITE BLOOD CELL COUNT INCREASED1
WHEEZING1
Weight fluctuation1
Weight abnormal1
VON WILLEBRAND'S DISEASE1
VOMITING PROJECTILE1
VISUAL IMPAIRMENT1
Visual acuity reduced transiently1
VISUAL ACUITY REDUCED1
VENTRICULAR TACHYCARDIA1
VENTRICULAR HYPERTROPHY1
VENTRICULAR EXTRASYSTOLES1
VAGINAL DISCHARGE1
URINE COLOUR ABNORMAL1
URINE ANALYSIS ABNORMAL1
URETHRITIS1
URETHRAL PAIN1
URETHRAL DISORDER1
UPPER LIMB FRACTURE1
UNRESPONSIVE TO STIMULI1
UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE1
Type 2 diabetes mellitus1
TREATMENT NONCOMPLIANCE1
Toxicity to various agents1
TOOTH LOSS1
TOOTH EXTRACTION1
TOOTH EROSION1
Tonic convulsion1
Thunderclap headache1
THROMBOTIC THROMBOCYTOPENIC PURPURA1
THROAT IRRITATION1
THIRST1
THERAPY RESPONDER1
THERAPY CESSATION1
THERAPEUTIC RESPONSE UNEXPECTED1
TESTICULAR SWELLING1
TESTICULAR OEDEMA1
TESTICULAR DISORDER1
TENSION HEADACHE1
Tenderness1
TEMPERATURE REGULATION DISORDER1
Telangiectasia1
TACHYPNOEA1
SWOLLEN TONGUE1
SWEAT DISCOLOURATION1
Suicidal behaviour1
SUDDEN DEATH1
SUBDURAL HAEMATOMA1
Status epilepticus1
Staring1
SOMNAMBULISM1
SOCIAL FEAR1
Social avoidant behaviour1
Skin ulcer1
SKIN DISCOLOURATION1
SKIN CHAPPED1
SHOPLIFTING1
Shock haemorrhagic1
SHOCK1
SEXUAL DYSFUNCTION1
SERUM SICKNESS1
SERUM SEROTONIN INCREASED1
SEROSITIS1
SEPSIS1
Sensory disturbance1
SENSATION OF HEAVINESS1
SENSATION OF FOREIGN BODY1
Seizure1
SCREAMING1
SCOTOMA1
SCOLIOSIS1
RHINORRHOEA1
Reversible cerebral vasoconstriction syndrome1
RESTLESS LEGS SYNDROME1
RESPIRATORY DISTRESS1
Relapsing-remitting multiple sclerosis1
REFUSAL OF EXAMINATION1
RED BLOOD CELL COUNT DECREASED1
REACTION TO DRUG EXCIPIENTS1
REACTION TO COLOURING1
Rash morbilliform1
RADICULITIS1
Pyelonephritis acute1
PYELONEPHRITIS1
PURULENCE1
Psychiatric decompensation1
Pseudophaeochromocytoma1
PRURITUS GENERALISED1
PROTHROMBIN TIME PROLONGED1
PROTEIN TOTAL DECREASED1
Product use issue1
Product storage error1
PRODUCT PACKAGING ISSUE1
Product administered to patient of inappropriate age1
PRESYNCOPE1
POSTMENOPAUSAL HAEMORRHAGE1
POST PROCEDURAL HAEMORRHAGE1
POISONING DELIBERATE1
Poisoning1
PLATELET COUNT DECREASED1
Plantar fasciitis1
PILOERECTION1
PIGMENTATION DISORDER1
PHYSICAL ASSAULT1
PHOTOPHOBIA1
Phaeochromocytoma1
PETIT MAL EPILEPSY1
Personality change1
PERONEAL NERVE PALSY1
PERIPHERAL COLDNESS1
PERICARDITIS1
PERICARDIAL EFFUSION1
PEPTIC ULCER1
Parkinson's disease1
PANCREATITIS1
Painful ejaculation1
PAINFUL DEFAECATION1
PAIN OF SKIN1
Pain in jaw1
Osteoarthritis1
ORAL PRURITUS1
OESOPHAGEAL STENOSIS1
OEDEMA MOUTH1
Obsessive-compulsive symptom1
NON-CARDIAC CHEST PAIN1
NO ADVERSE EVENT1
NEUROGENIC BLADDER1
NEURALGIA1
Nerve injury1
Neck injury1
NEAR DROWNING1
Nasopharyngitis1
MYOFASCIAL PAIN SYNDROME1
MYOCLONUS1
MYOCARDIAL ISCHAEMIA1
Mutism1
Musculoskeletal disorder1
MUSCLE TWITCHING1
MUSCLE TIGHTNESS1
Muscle haemorrhage1
MUSCLE CONTRACTIONS INVOLUNTARY1
Multiple sclerosis relapse1
MULTIPLE ALLERGIES1
Multi-organ failure1
Motion sickness1
MORBID THOUGHTS1
Mobility decreased1
Mixed liver injury1
Middle insomnia1
MICROLITHIASIS1
MESENTERIC ARTERY THROMBOSIS1
MENINGITIS1
MATERNAL EXPOSURE DURING PREGNANCY1
Lymphoedema1
Lymphadenopathy1
LOCAL SWELLING1
LOBAR PNEUMONIA1
Liver disorder1
Livedo reticularis1
LEUKOPENIA1
Lethargy1
LEGAL PROBLEM1
LAGOPHTHALMOS1
Lack of spontaneous speech1
LABORATORY TEST ABNORMAL1
JOINT SWELLING1
JOINT DISLOCATION1
JAW DISORDER1
JAUNDICE1
ISCHAEMIC STROKE1
IRRITABLE BOWEL SYNDROME1
Interstitial lung disease1
Intercepted drug dispensing error1
Intentional self-injury1
Intentional product misuse1
INJURY1
INCREASED TENDENCY TO BRUISE1
Incorrect product storage1
INCOHERENT1
Inappropriate antidiuretic hormone secretion1
IMPULSE-CONTROL DISORDER1
Impaired gastric emptying1
Immune thrombocytopenic purpura1
IMMUNE SYSTEM DISORDER1
Ileus1
IDIOPATHIC THROMBOCYTOPENIC PURPURA1
HYPOVOLAEMIA1
HYPOTONIC URINARY BLADDER1
HYPOMAGNESAEMIA1
HYPOKALAEMIA1
Hypochloraemia1
HYPOAESTHESIA FACIAL1
HYPOACUSIS1
HYPERTENSIVE ENCEPHALOPATHY1
Hypersexuality1
HYPERREFLEXIA1
HYPERGLYCAEMIA1
Hyperchlorhydria1
Hyperammonaemia1
HYPERAESTHESIA1
HYPERACUSIS1
Hostility1
HIATUS HERNIA1
HERPES ZOSTER1
HEPATITIS CHOLESTATIC1
HEPATIC LESION1
Hepatic failure1
Helicobacter infection1
HEAT EXHAUSTION1
Heart transplant1
HEART RATE IRREGULAR1
Head injury1
HEAD DISCOMFORT1
Hallucinations, mixed1
HALLUCINATION, VISUAL1
HALLUCINATION, AUDITORY1
HAEMORRHOIDS1
HAEMORRHAGE URINARY TRACT1
Haemolytic anaemia1
HAEMOGLOBIN DECREASED1
HAEMATOCRIT DECREASED1
HAEMATOCHEZIA1
Haematemesis1
Gynaecomastia1
GUN SHOT WOUND1
GLOMERULAR FILTRATION RATE DECREASED1
GINGIVAL RECESSION1
GINGIVAL PAIN1
Generalised tonic-clonic seizure1
GENERAL PHYSICAL HEALTH DETERIORATION1
GASTROINTESTINAL NECROSIS1
GASTROENTERITIS1
GASTRITIS1
GASTRIC DISORDER1
Gait disturbance1
FORMICATION1
FOOD POISONING1
FLUID RETENTION1
FLANK PAIN1
FIBROCYSTIC BREAST DISEASE1
FEELING OF DESPAIR1
FEELING DRUNK1
FEAR OF DEATH1
FEAR1
FACE OEDEMA1
EYE MOVEMENT DISORDER1
EYE DISCHARGE1
EXTRAPYRAMIDAL DISORDER1
Exposure during pregnancy1
Excoriation1
EUPHORIC MOOD1
ERYTHEMA MULTIFORME1
ERUCTATION1
ENDOMETRIAL CANCER1
Endometrial adenocarcinoma1
ENDODONTIC PROCEDURE1
Encephalitis1
ELECTROCARDIOGRAM T WAVE INVERSION1
ELECTROCARDIOGRAM ST-T CHANGE1
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION1
ELECTROCARDIOGRAM POOR R-WAVE PROGRESSION1
EATING DISORDER1
Ear infection1
EAR CONGESTION1
DYSARTHRIA1
Dysaesthesia1
Dry throat1
DRY SKIN1
DRUG WITHDRAWAL SYNDROME1
Drug screen false positive1
Drug level increased1
DRUG ERUPTION1
DISSOCIATION1
DISORIENTATION1
DISINHIBITION1
Diabetes mellitus1
DERMATITIS EXFOLIATIVE1
DERMATITIS1
DEPRESSED MOOD1
DENTAL CARIES1
Dementia1
DECREASED ACTIVITY1
Deafness transitory1
CYSTITIS1
CUTANEOUS LUPUS ERYTHEMATOSUS1
CREATININE RENAL CLEARANCE INCREASED1
CREATININE RENAL CLEARANCE DECREASED1
COUGH1
COORDINATION ABNORMAL1
COMPLEX PARTIAL SEIZURES1
COLITIS ULCERATIVE1
Circulatory collapse1
Cholestasis1
CHOKING SENSATION1
Central nervous system lesion1
CELLULITIS1
CATECHOLAMINES URINE INCREASED1
Catatonia1
Carotid artery occlusion1
Carotid artery dissection1
CARDIOVASCULAR DISORDER1
Cardiogenic shock1
Cardio-respiratory arrest1
CARDIAC FAILURE1
CAPILLARY FRAGILITY1
BUNDLE BRANCH BLOCK RIGHT1
Bronchitis1
BREAST TENDERNESS1
BREAST PAIN1
BREAST CANCER1
Bone marrow failure1
Body height decreased1
BLOOD URINE PRESENT1
BLOOD TRIGLYCERIDES INCREASED1
BLOOD PRESSURE FLUCTUATION1
Blood pressure diastolic increased1
BLOOD MAGNESIUM1
BLOOD BILIRUBIN INCREASED1
Bladder dilatation1
Bifascicular block1
BARRETT'S OESOPHAGUS1
AXILLARY PAIN1
AUTOIMMUNE HEPATITIS1
AUTOIMMUNE DISORDER1
AURICULAR SWELLING1
ASTHMA1
ASPARTATE AMINOTRANSFERASE DECREASED1
Arthropathy1
Aplastic anaemia1
Apathy1
AORTIC DISSECTION1
ANURIA1
ANORGASMIA1
ANGLE CLOSURE GLAUCOMA1
Androgen deficiency1
ANAPHYLACTIC SHOCK1
ANAPHYLACTIC REACTION1
Altered state of consciousness1
ALANINE AMINOTRANSFERASE DECREASED1
Akinesia1
AKINAESTHESIA1
AKATHISIA1
AGORAPHOBIA1
ADVERSE REACTION1
Adrenomegaly1
ADRENAL INSUFFICIENCY1
ACUTE MYOCARDIAL INFARCTION1
ACTIVITIES OF DAILY LIVING IMPAIRED1
Acquired claw toe1
ACCIDENTAL OVERDOSE1
Abortion induced1





Filtered ChEMBL targets:

Target UniProtKB ID Activity in nm Target Name Target gene
P23975 5500 Sodium-dependent noradrenaline transporter SC6A2_HUMAN
P31645 22 Sodium-dependent serotonin transporter SC6A4_HUMAN



Toxicity information:

Toxicity class: 4
Toxicity type: N/A
LD50: 316 mg/kg



External links:

ChEBML: CHEMBL252923
DrugBank: DB04896