Dinoprostone


w157



General information:


Withdrawn ID: w157
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): G02AD02
Molecular Formula: C20H32O5
Molweight: 352.465



Withdrawal information:


Withdrawn due to drug safety reasons:Yes
First approved: 1977
First withdrawn: 1990
Last withdrawn: 1990
Reference: https://dij.sagepub.com/content/35/1/293.full.pdf



Side-effects:

Total reported cases (submitted by medical professionals) with Dinoprostone as primary suspect: 412


Reported final outcomes:
Hospitalization (initial or prolonged): 94
Life-Threatening condition: 73
Death: 59
Intervention required to prevent permanent impairment/damage: 15
Disability: 11
Congenital anomaly: 3


Reported side-effects:

Side-effect Case number
DRUG EXPOSURE DURING PREGNANCY60
CAESAREAN SECTION60
PREMATURE SEPARATION OF PLACENTA42
Uterine hyperstimulation33
UTERINE HYPERTONUS32
DISSEMINATED INTRAVASCULAR COAGULATION29
POSTPARTUM HAEMORRHAGE28
FOETAL DISTRESS SYNDROME25
UTERINE RUPTURE23
Foetal heart rate deceleration abnormality22
NEONATAL ASPHYXIA21
OFF LABEL USE19
Foetal death19
DRUG INEFFECTIVE19
BRADYCARDIA FOETAL18
APGAR SCORE LOW18
MATERNAL DRUGS AFFECTING FOETUS15
Uterine tachysystole14
ANAPHYLACTOID SYNDROME OF PREGNANCY14
UTERINE CONTRACTIONS ABNORMAL12
TACHYCARDIA12
MATERNAL EXPOSURE DURING PREGNANCY11
DYSPNOEA11
DEATH NEONATAL11
VOMITING10
FOETAL HEART RATE DECELERATION10
Vulvovaginal swelling9
UTERINE HAEMORRHAGE9
Product use issue9
MALAISE9
Foetal exposure during delivery9
VAGINAL HAEMORRHAGE8
UTERINE ATONY8
TACHYCARDIA FOETAL8
Pyrexia8
FOETAL HEART RATE ABNORMAL8
Contraindicated product administered8
COMPLICATIONS OF MATERNAL EXPOSURE TO THERAPEUTIC DRUGS8
Tremor7
STILLBIRTH7
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY7
HYPERSENSITIVITY7
CONVULSION NEONATAL7
Vulvovaginal pain6
SEPSIS NEONATAL6
Nonreassuring foetal heart rate pattern6
HYPOTENSION6
HAEMORRHAGE6
Vulvovaginal erythema5
Vulvovaginal dryness5
Vulvovaginal discomfort5
Pain5
Overdose5
OEDEMA GENITAL5
NAUSEA5
MECONIUM STAIN5
LABOUR COMPLICATION5
HYPERTENSION5
Foetal monitoring abnormal5
FOETAL HEART RATE DISORDER5
FOETAL HEART RATE DECREASED5
Exposure during pregnancy5
DEATH5
BLOOD PH DECREASED5
Apnoea5
Amniotic cavity infection5
ABNORMAL LABOUR5
Vulvovaginal burning sensation4
SHOCK4
PRODUCT QUALITY ISSUE4
Precipitate labour4
PLACENTAL DISORDER4
PHARMACEUTICAL PRODUCT COMPLAINT4
PALLOR4
METABOLIC ACIDOSIS4
Meconium in amniotic fluid4
INCORRECT DRUG ADMINISTRATION DURATION4
HYSTERECTOMY4
HAEMOGLOBIN DECREASED4
Foetal exposure during pregnancy4
FAILED INDUCTION OF LABOUR4
Drug administration error4
DISCOMFORT4
CEREBRAL PALSY4
CARDIO-RESPIRATORY ARREST4
ARRESTED LABOUR4
ANAPHYLACTIC SHOCK4
ABDOMINAL PAIN4
Vulvovaginal pruritus3
Vulval oedema3
Vertigo3
Vaginal oedema3
UMBILICAL CORD AROUND NECK3
Therapeutic product effect incomplete3
SYNCOPE3
Shock haemorrhagic3
Seizure3
Product use in unapproved indication3
Prescribed overdose3
PLACENTAL INSUFFICIENCY3
Perineal pain3
Obstructed labour3
OBSTETRICAL PULMONARY EMBOLISM3
NO THERAPEUTIC RESPONSE3
MULTI-ORGAN FAILURE3
METRORRHAGIA3
Loss of consciousness3
Intrapartum haemorrhage3
INTRA-UTERINE DEATH3
HYPOXIC ENCEPHALOPATHY3
HYPOXIA3
FORCEPS DELIVERY3
Foetal acidosis3
Dysuria3
DIZZINESS3
COMPLICATION OF DELIVERY3
Cardiac arrest3
Bradycardia3
BACK PAIN3
Asthenia3
ANAPHYLACTOID REACTION3
ANAPHYLACTIC REACTION3
ACUTE PULMONARY OEDEMA3
ABNORMAL LABOUR AFFECTING FOETUS3
VAGINAL LACERATION2
Urinary retention2
UNEVALUABLE EVENT2
UMBILICAL CORD ABNORMALITY2
THROMBOCYTOPENIA2
SMALL FOR DATES BABY2
SINUS TACHYCARDIA2
RESUSCITATION2
Restlessness2
RESPIRATORY FAILURE2
RESPIRATORY DISTRESS2
RENAL FAILURE2
RASH2
Product packaging issue2
Product monitoring error2
Product administration error2
Premature rupture of membranes2
PREMATURE BABY2
PNEUMONIA2
PLACENTA ACCRETA2
Patent ductus arteriosus2
PARAESTHESIA2
PAIN IN EXTREMITY2
OXYGEN SATURATION DECREASED2
Neonatal respiratory distress syndrome2
Neonatal hypoxia2
NEONATAL DISORDER2
MYOCLONUS2
MYOCARDIAL ISCHAEMIA2
Muscular weakness2
MUSCLE SPASMS2
Maternal exposure during delivery2
MATERNAL CONDITION AFFECTING FOETUS2
Labour pain2
IRRITABILITY2
Infection2
INFARCTION2
Incorrect product administration duration2
INCORRECT DOSE ADMINISTERED2
HYPOTONIA2
HEART RATE INCREASED2
HEART RATE DECREASED2
Headache2
Gynaecological examination abnormal2
FOREIGN BODY TRAUMA2
FOETAL DISORDER2
FLUSHING2
Fever neonatal2
Dysgeusia2
Drug monitoring procedure incorrectly performed2
Cough2
CONVULSION2
Condition aggravated2
COMPLICATION OF PREGNANCY2
CEREBRAL ISCHAEMIA2
CARDIOMYOPATHY2
CARDIOGENIC SHOCK2
Brain injury2
Bradycardia neonatal2
BLOOD PRESSURE INCREASED2
BLOOD PRESSURE DECREASED2
Asthma2
Abortion induced2
Abdominal pain upper2
Abdominal pain lower2
Wrong technique in product usage process1
Wrong product administered1
Wrong drug administered1
White matter lesion1
WEIGHT INCREASED1
VISUAL DISTURBANCE1
Vision blurred1
Vaginal infection1
VAGINAL DISORDER1
Uterine inflammation1
Uterine disorder1
UTERINE CONTRACTIONS DURING PREGNANCY1
URINARY BLADDER RUPTURE1
Urethral stenosis1
Urethral disorder1
Ureteric injury1
UNRESPONSIVE TO STIMULI1
Underweight1
TROPONIN INCREASED1
Treatment failure1
Transient tachypnoea of the newborn1
TONGUE BITING1
TINNITUS1
Thyroid disorder1
Third stage postpartum haemorrhage1
THERAPY NON-RESPONDER1
Therapy interrupted1
Therapeutic response unexpected1
Therapeutic response decreased1
THALAMIC INFARCTION1
TETANUS1
TEMPERATURE INTOLERANCE1
Talipes1
Tachypnoea1
Tachyarrhythmia1
SWELLING FACE1
SWELLING1
Supraventricular tachycardia1
Sudden infant death syndrome1
Streptococcal sepsis1
Status epilepticus1
Somnolence1
Skin ulcer1
SKIN BURNING SENSATION1
Shoulder dystocia1
Sensitivity to weather change1
REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME1
Retroplacental haematoma1
Retained placenta or membranes1
Respiratory disorder1
Respiratory arrest1
RESPIRATION ABNORMAL1
Renal impairment1
Renal dysplasia1
Raynaud's phenomenon1
Rash neonatal1
Pyelonephritis acute1
Pulse absent1
PULMONARY OEDEMA1
Puerperal infection1
Pruritus1
PROTEIN URINE PRESENT1
Prolonged labour1
Product shape issue1
Product physical issue1
Procedural haemorrhage1
PROCEDURAL COMPLICATION1
Presyncope1
Premature delivery1
Pre-eclampsia1
Postpartum sepsis1
Postpartum disorder1
POSTICTAL STATE1
Post procedural haemorrhage1
POST PROCEDURAL COMPLICATION1
Poisoning deliberate1
PO2 DECREASED1
Pneumomediastinum1
Pleural effusion1
Periventricular leukomalacia1
Peritonitis1
Peritoneal haemorrhage1
PERITONEAL HAEMATOMA1
Peripheral venous disease1
PERIPHERAL CIRCULATORY FAILURE1
Pelvic pain1
PCO2 INCREASED1
OVARIAN HYPERSTIMULATION SYNDROME1
OVARIAN HAEMORRHAGE1
Osteochondrodysplasia1
OPERATIVE HAEMORRHAGE1
Oedema peripheral1
Obstructive pancreatitis1
OBSTETRIC PROCEDURE COMPLICATION1
NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL1
No adverse event1
Neuromuscular blockade1
Nervousness1
NEONATAL RESPIRATORY DEPRESSION1
Neonatal pneumonia1
Neonatal infection1
NEONATAL ASPIRATION1
Nasal flaring1
MUSCULOSKELETAL STIFFNESS1
Musculoskeletal pain1
Moaning1
MENINGISM1
Medication error1
MEDICAL OBSERVATION ABNORMAL1
MECONIUM INCREASED1
Meconium aspiration syndrome1
MATERNAL DISTRESS DURING LABOUR1
Maternal death during childbirth1
Liver disorder1
Lip oedema1
Life support1
Leukocytosis1
LETHARGY1
Learning disorder1
Lactic acidosis1
Jaundice neonatal1
Intercepted drug administration error1
Influenza like illness1
Infected skin ulcer1
Infantile apnoea1
INCORRECT ROUTE OF DRUG ADMINISTRATION1
INADEQUATE ANALGESIA1
Ileus paralytic1
IATROGENIC INJURY1
HYPOVOLAEMIC SHOCK1
Hypotonia neonatal1
Hypoglycaemia1
HYPOCALCAEMIA1
Hyperventilation1
HYPERTHERMIA1
Hypertensive nephropathy1
HYPERKALAEMIA1
Hypercapnia1
Hydrothorax1
Hydronephrosis1
Hot flush1
Hereditary angioedema1
Heart rate variability decreased1
Heart disease congenital1
Haemorrhagic anaemia1
Haemoptysis1
HAEMODYNAMIC TEST ABNORMAL1
HAEMODYNAMIC INSTABILITY1
Haematoma1
HAEMATOCRIT DECREASED1
Haematochezia1
Haematemesis1
Gestational hypertension1
Genital swelling1
GENERALISED OEDEMA1
GENERAL PHYSICAL CONDITION ABNORMAL1
GASTROINTESTINAL PAIN1
GASTROINTESTINAL DISORDER1
Gait inability1
Fungal infection1
Foetal arrhythmia1
Foetal anaemia1
Floppy infant1
Fall1
Failure to suspend medication1
Face oedema1
EVACUATION OF RETAINED PRODUCTS OF CONCEPTION1
Epilepsy1
Endometritis decidual1
Endometritis1
ELECTROENCEPHALOGRAM ABNORMAL1
Eclampsia1
Dysphoria1
DRUG HYPERSENSITIVITY1
Drug effective for unapproved indication1
DRUG EFFECT DECREASED1
Disease recurrence1
Diarrhoea1
DEVICE FAILURE1
DEVICE EXPULSION1
DEVICE BREAKAGE1
Depressed level of consciousness1
Dehydration1
DEFAECATION URGENCY1
CYSTITIS HAEMORRHAGIC1
Cyanosis neonatal1
CYANOSIS1
Contraindicated drug administered1
CONGENITAL BRAIN DAMAGE1
COMPLICATION OF DEVICE REMOVAL1
COMA1
Coagulopathy1
CIRCULATORY COLLAPSE1
Cholecystitis chronic1
Chills1
CHEST PAIN1
Chest discomfort1
Cervix oedema1
Cervix haemorrhage uterine1
CERVIX DISORDER1
Cerebrovascular accident1
Cerebral infarction1
CARDIAC FAILURE1
Burning sensation1
BRONCHOSPASM1
Broad ligament haematoma1
BREECH DELIVERY1
BREAST FEEDING1
Brain stem syndrome1
Bone hypertrophy1
Blood pressure systolic increased1
BLOOD LACTATE DEHYDROGENASE INCREASED1
BLOOD GASES ABNORMAL1
BLOOD FIBRINOGEN INCREASED1
BLOOD CULTURE POSITIVE1
BLOOD BICARBONATE INCREASED1
BLOOD BICARBONATE DECREASED1
BLADDER INJURY1
ATRIAL THROMBOSIS1
Atonic urinary bladder1
ATELECTASIS1
ASPARTATE AMINOTRANSFERASE INCREASED1
Application site pain1
Application site oedema1
Application site discomfort1
Apparent life threatening event1
Apparent death1
APALLIC SYNDROME1
ANTITHROMBIN III DECREASED1
ALANINE AMINOTRANSFERASE INCREASED1
Agitation1
Acute respiratory distress syndrome1
Acute kidney injury1
ABDOMINAL DISCOMFORT1





Filtered ChEMBL targets:

Target UniProtKB ID Activity in nm Target Name Target gene
P16473 10 Thyrotropin receptor TSHR_HUMAN
P28482 100 Mitogen-activated protein kinase 1 MK01_HUMAN
P34995 3.7 Prostaglandin E2 receptor EP1 subtype PE2R1_HUMAN
P35408 0.02 Prostaglandin E2 receptor EP4 subtype PE2R4_HUMAN
P43088 250 Prostaglandin F2-alpha receptor PF2R_HUMAN
P43115 0.33 Prostaglandin E2 receptor EP3 subtype PE2R3_HUMAN
P43116 1.03 Prostaglandin E2 receptor EP2 subtype PE2R2_HUMAN
P43119 260 Prostacyclin receptor PI2R_HUMAN



Toxicity information:

Toxicity class: 3
Toxicity type: muscular
LD50: 186 mg/kg



External links:

ChEBML: CHEMBL548
DrugBank: DB00917