Reported safety narratives, with historical warnings and uncertain findings separated. Read the record and supporting citations before drawing conclusions.
Estrogen therapy carries FDA boxed warnings: endometrial cancer (unopposed estrogen), cardiovascular/stroke/VTE events, breast cancer and probable dementia (WHI findings)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Dose-related seizure risk (dalfampridine label warning)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.TCA boxed warning: suicidal ideation in children/young adults; cardiotoxicity in overdose
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Amphetamine: boxed warning for abuse/dependence (Schedule II). Atomoxetine: boxed warning for suicidal ideation in children/adolescents.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Suspended worldwide 2007-2008 after BART trial showed increased mortality vs other antifibrinolytics; reintroduced with restrictions in EU (2012) and Canada; remains unavailable in the US
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.GI bleeding/Reye's syndrome (established class warnings)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Epicel: FDA 'effectiveness not demonstrated'; SCC warning added 2022
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Abrupt withdrawal (esp. intrathecal) can cause life-threatening withdrawal syndrome (label warning)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.JAK-inhibitor class boxed warning: serious infections, mortality, malignancy, MACE, thrombosis
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Withdrawn/banned in most countries due to bromism (neurotoxicity), addiction, and overdose/suicide risk (ChEMBL withdrawn_flag = true)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Marketing authorisation suspended in France (Feb 2011) and across the EU by EMA (2011) due to serious/fatal neurological (seizures, status epilepticus) and cardiac (arrhythmia, cardiac arrest) toxicity. ChEMBL withdrawn_flag set.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Risk of hypercalcaemia/hypercalciuria (label warning); no market withdrawal
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA warning (2017) re: rare but serious anaphylaxis with chlorhexidine gluconate skin antiseptics
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Withdrawn (US 2002); WHO Primary Prevention trial showed ~25% increase in all-cause mortality (excess non-cardiovascular deaths, cancer, gallstones, pancreatitis)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warnings: nephrotoxicity, increased susceptibility to infection and malignancy (lymphoma/skin) due to immunosuppression
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.No withdrawal; class corticosteroid warnings. NB: MRC CRASH trial showed corticosteroids INCREASE mortality in acute head injury (stopped early for harm)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Hypotension, bradycardia and sinus arrest (label); no withdrawal
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.NSAID boxed warnings: serious cardiovascular thrombotic events (MI/stroke) and serious GI bleeding/ulceration/perforation.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Boxed warning: spinal/epidural haematoma with neuraxial anaesthesia/puncture
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warnings: increased risk of serious infections and malignancy (incl. lymphoma); topical - possible malignancy risk
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warning: increased risk of suicidal thinking/behavior in children, adolescents, and young adults
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.EMA/PRAC-endorsed withdrawal of marketing authorisation across EU in 2018 due to risk of acute liver failure (hepatotoxicity)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Serious warnings: bradyarrhythmia/AV block at first dose, progressive multifocal leukoencephalopathy, macular edema, infections, and severe MS disease rebound after discontinuation
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Hypoglycaemia risk (label). IV glibenclamide (BIIB093/CIRARA) for cerebral oedema after large hemispheric infarction: phase 3 CHARM overall primary endpoint not met, with positive functional-ambulation signals in subgroups (still investigational).
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.EMA marketing authorisation withdrawn 11 Feb 2020 and global LEO withdrawal; increased skin malignancy (SCC) risk outweighs benefit (PRAC April 2020)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.COVID-19 authorisation is conditional/EUA and suPAR-restricted; injection-site reactions and infection risk (label). SAVE-MORE trial supported EMA approval/FDA EUA.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Multiple boxed warnings: GI bleeding/perforation, renal, bleeding risk; contraindicated in labour/delivery and CABG
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Endari well tolerated (no boxed warning). NB: REDOXS trial (NEJM 2013) found early high-dose glutamine INCREASED mortality in critically ill/multi-organ-failure patients
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.1989-90 eosinophilia-myalgia syndrome (EMS) outbreak: >1,500 cases and 37 deaths traced to contaminated Showa Denko batches; FDA nationwide recall/ban 1990 (returned ~2005). ChEMBL withdrawn_flag set.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Neuropsychiatric/behavioural adverse effects and rare serious skin reactions (label warnings); no withdrawal. In status epilepticus (ESETT) levetiracetam was comparable/non-inferior to fosphenytoin and valproate.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Boxed warning: fetal toxicity (discontinue in pregnancy); angioedema risk
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Withdrawn (ChEMBL withdrawn_flag = true); hepatotoxicity and androgenic adverse effects; banned/controlled substance
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Boxed warning for rare lactic acidosis; no withdrawal
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Long-term ORAL milrinone increased mortality (PROMISE trial) - oral use abandoned; IV use only
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Anaphylactoid reactions with IV administration (label); no withdrawal. NAC is established standard-of-care antidote for acetaminophen-induced acute liver injury.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Boxed warning: death and serious life-threatening events after inadvertent IV administration of capsule contents; IV solution not FDA-approved in US
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warning: extravasation causes tissue necrosis/sloughing (requires central line/antidote phentolamine)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Boxed warning against elective (non-medical) labour induction; uterine hyperstimulation risk
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warning: serious/life-threatening neuropsychiatric events (aggression, hostility, homicidal/suicidal ideation)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Hepatotoxicity and photosensitivity (label warnings); no withdrawal
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Withdrawn from major markets (e.g. US) due to QT prolongation / torsades-de-pointes risk and marked HDL-cholesterol lowering. ChEMBL withdrawn_flag set.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Withdrawn from all markets Oct 2011 by Eli Lilly after PROWESS-SHOCK showed no survival benefit; bleeding risk
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA 2008 Public Health Notification: life-threatening cervical airway/soft-tissue swelling with off-label cervical use; indication narrowed to when autograft not feasible; ongoing efficacy-vs-autograft and cancer-risk debate
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.ASCEND-HF (2011, n=7141) showed no benefit on death/HF rehospitalization; use collapsed and Janssen discontinued manufacturing (2018)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warning for erythropoiesis-stimulating agents: increased mortality, serious cardiovascular/thromboembolic events, and tumour progression. EPO-TBI (Lancet 2015) and meta-analyses showed no neuroprotective benefit in TBI.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Temporarily withdrawn from US market 1999-2002 over manufacturing/safety concerns, later reintroduced (Kinlytic); note related CLEAR III trial (intraventricular alteplase, not urokinase) was neutral on functional outcome
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Bleeding risk (class effect); FDA warnings re: spinal/epidural haematoma and premature discontinuation
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Withdrawn worldwide 30 Sept 2004 (Merck voluntary) due to increased myocardial infarction/stroke risk (APPROVe/VIGOR)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.EMA suspended EU marketing authorisation (Sept 2010) for increased cardiovascular (ischaemic) risk; FDA imposed a boxed warning and restricted-access REMS program (later eased in 2013 and removed 2015). ChEMBL withdrawn_flag set.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warning: may increase risk of myocardial infarction, stroke, and cardiovascular death (from ARCH trial imbalance)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.No market withdrawal; selenium toxicity (selenosis) at high doses
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Dose-related myopathy/rhabdomyolysis; FDA 2011 restricted use of 80 mg dose. Statins broadly showed no benefit in acute lung injury/sepsis (e.g. HARP-2).
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warning: risk of serious/life-threatening methemoglobinemia and hypotension
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warnings: hepatotoxicity, teratogenicity (neural tube defects, reduced IQ), and pancreatitis
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Opioid boxed warning: addiction, abuse, misuse, life-threatening respiratory depression; Schedule II controlled substance.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warning: serious or fatal respiratory failure (higher risk in volume overload / ACLF grade 3)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warnings: blood pressure increase/cardiovascular risk; abuse potential; risk of secondary exposure (virilization) to women/children
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Boxed warning: bleeding risk; and reduced efficacy with maintenance aspirin >100 mg/day
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Warnings for serious/fatal bleeding including symptomatic intracranial hemorrhage; narrow therapeutic time window (within 3-4.5 h) and numerous contraindications
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Boxed warning: addiction/abuse/misuse, life-threatening respiratory depression, ultra-rapid metaboliser risk (contraindicated in children post-tonsillectomy)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Dose-dependent seizure risk and thromboembolism (label); no withdrawal. CRASH-2 (20,211 trauma patients) showed reduced all-cause mortality and death due to bleeding; on WHO Essential Medicines list and standard-of-care in trauma.
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Hepatotoxicity; withdrawn from markets (e.g., Australia, France); Loprinzi NEJM 1999 RCT found no benefit for lymphoedema and a case of hepatotoxicity; ChEMBL withdrawn_flag true
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warnings: hepatotoxicity, teratogenicity, pancreatitis
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.High-dose IV vitamin C in sepsis/critical illness: CITRIS-ALI (JAMA 2019) no SOFA benefit; LOVIT (NEJM 2022) showed increased risk of death or persistent organ dysfunction (harm signal).
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.High-dose vitamin E associated in meta-analyses with increased all-cause mortality and haemorrhagic-stroke risk; no market withdrawal
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.FDA boxed warning: bleeding risk; contraindicated in patients with prior stroke/TIA/ICH or active bleeding
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.No market withdrawal; chronic high-dose zinc can cause copper deficiency
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.Withdrawn from US market (2000) and Canada (2003) due to agranulocytosis (also vasculitis, leukoencephalopathy)
The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.