{
 "query": "venlafaxine",
 "ingredient": "venlafaxine",
 "slug": "venlafaxine",
 "rxcui": "39786",
 "brands": [
  "Effexor"
 ],
 "names": [
  "venlafaxine",
  "venlafaxine besylate",
  "venlafaxine besylate monohydrate",
  "venlafaxine hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 182
  },
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] . Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patient s [see Use in Specific Populations (8.4) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric patients and young adults taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients ( 8.4 ).",
  "indications_and_usage": "Venlafaxine Hydrochloride Extended-Release Capsules, USP are indicated in adults for the treatment of: Major Depressive Disorder (MDD) [see Clinical Studies (14.1) ] Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2) ] Social Anxiety Disorder (SAD) [see Clinical Studies (14.3) ] Panic Disorder (PD) [see Clinical Studies (14.4) ] Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: Major Depressive Disorder (MDD) ( 1 ) Generalized Anxiety Disorder (GAD) ( 1 ) Social Anxiety Disorder (SAD) ( 1 ) Panic Disorder (PD) ( 1 )",
  "contraindications": "Venlafaxine Hydrochloride Extended-Release Capsules are contraindicated in patients: with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see Adverse Reactions (6.2) ] . taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see Dosage and Administration (2.11) , Warnings and Precautions (5.2) , and Drug Interactions (7.1) ] . Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the venlafaxine hydrochloride extended-release capsules formulation ( 4 ). Concomitant use of monoaminoxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI ( 4 , 5.2 , 7.1 ).",
  "warnings_and_cautions": "Serotonin Syndrome : Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue venlafaxine hydrochloride extended-release capsules and serotonergic agents and initiate supportive treatment ( 4 , 5.2 , 7.1 ). Elevated Blood Pressure : Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment ( 5.3 ). Increased Risk of Bleeding : Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase risk ( 5.4 ). Angle-Closure Glaucoma : Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles, treated with antidepressants ( 5.5 ). Activation of Mania or Hypomania : Screen patients for bipolar disorder ( 5.6 ). Discontinuation Syndrome : Taper dose and monitor for discontinuation symptoms ( 5.7 ). Seizures : Can occur. Use cautiously in patients with seizure disorder ( 5.8 ). Hyponatremia : Can occur in association with SIADH ( 5.9 ). Interstitial Lung Disease and Eosinophilic Pneumonia : Can occur ( 5.12 ). Sexual Dysfunction : Venlafaxine hydrochloride extended-release capsules may cause symptoms of sexual d...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity [see Contraindications (4) ] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Elevated Blood Pressure [see Warnings and Precautions (5.3) ] Increased Risk of Bleeding [see Warnings and Precautions (5.4) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.5) ] Activation of Mania/Hypomania [see Warnings and Precautions (5.6) ] Discontinuation Syndrome [see Warnings and Precautions (5.7) ] Seizure [see Warnings and Precautions (5.8) ] Hyponatremia [see Warnings and Precautions (5.9) ] Weight and Height Changes in Pediatric Patients [see Warnings and Precautions (5.10) ] Appetite Changes in Pediatric Patients [see Warnings and Precautions (5.11) ] Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions (5.12) ] Sexual Dysfunction [see Warnings and Precautions (5.13) ] Most common adverse reactions (incidence \u22655% and at least twice the rate of placebo): nausea, somnolence, dry mouth, sweating, abnormal ejaculation, anorexia, constipat...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Venlafaxine hydrochloride extended-release capsules contain venlafaxine which is not a controlled substance. 9.2 Abuse Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. While venlafaxine has not been systematically studied in clinical studies for its potential for abuse, there was no indication of drug-seeking behavior in the clinical studies. However, it is not possible to predict on the basis of premarketing experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, providers should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior). 9.3 Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. In vitro studies revealed that venlafaxine has virtually no affinity fo...",
  "controlled_substance": "9.1 Controlled Substance Venlafaxine hydrochloride extended-release capsules contain venlafaxine which is not a controlled substance.",
  "recent_major_changes": "Warnings and Precautions ( 5.2 , 5.4 ) 8/2023",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions (5.1) ] . Concomitant Medication Instruct patients not to take venlafaxine hydrochloride extended-release capsules with an MAOI or within 14 days of stopping an MAOI [see Contraindications (4) ] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of venlafaxine hydrochloride extended-release capsules with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John\u2019s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome ...",
  "spl_medguide": "Dispense with Medication Guide available at: www.epic-pharma.com/medguide/Venlafaxine-Hydrochloride-ER-Capsule.pdf MEDICATION GUIDE Venlafaxine Hydrochloride (ven'' la fax' een hye'' droe klor' ide) Extended-Release Capsules What is the most important information I should know about venlafaxine hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules may cause serious side effects, including: Increased risk of suicidal thoughts and actions. Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Venlafaxine hydrochloride extended-release capsules are not for use in children. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started...",
  "clinical_studies": "14.1 Major Depressive Disorder The efficacy of venlafaxine hydrochloride extended-release capsules as a treatment for Major Depressive Disorder (MDD) was established in two placebo-controlled, short-term (8 weeks for study 1; 12 weeks for study 2), flexible-dose studies, with doses starting at 75 mg per day and ranging to 225 mg per day in adult outpatients meeting DSM-III-R or DSM-IV criteria for MDD. In moderately depressed outpatients, the initial dose of venlafaxine was 75 mg per day. In both studies, venlafaxine hydrochloride extended-release capsules demonstrated superiority over placebo on the primary efficacy measure defined as change from baseline in the HAM-D-21 total score to the endpoint visit, venlafaxine hydrochloride extended-release capsules also demonstrated superiority over placebo on the key secondary efficacy endpoint, the Clinical Global Impressions (CGI) Severity of Illness scale. Examination of gender subsets of the population studied did not reveal any differential responsiveness on the basis of gender. A 4-week study of inpatients meeting DSM-III-R criteria for MDD with melancholia utilizing venlafaxine hydrochloride tablets in a range of 150 to 375 mg per ...",
  "brand_name": "Venlafaxine Hydrochloride",
  "manufacturer": "Advanced Rx Pharmacy of Tennessee, LLC",
  "application_number": "ANDA214654",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240530",
  "set_id": "19b1543e-d599-a869-e063-6294a90a8e28",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 110473,
  "serious": 81226,
  "death": 11045,
  "hospitalization": 35000,
  "primary_suspect": 109432,
  "top_reactions": [
   [
    "Drug Ineffective",
    9596
   ],
   [
    "Nausea",
    7366
   ],
   [
    "Fatigue",
    7149
   ],
   [
    "Headache",
    6225
   ],
   [
    "Off Label Use",
    6170
   ],
   [
    "Dizziness",
    5152
   ],
   [
    "Toxicity To Various Agents",
    4618
   ],
   [
    "Anxiety",
    4583
   ],
   [
    "Depression",
    4583
   ],
   [
    "Diarrhoea",
    4561
   ],
   [
    "Pain",
    4401
   ],
   [
    "Fall",
    4006
   ],
   [
    "Vomiting",
    3918
   ],
   [
    "Dyspnoea",
    3740
   ],
   [
    "Drug Interaction",
    3727
   ]
  ],
  "by_year": {
   "2019": 11714,
   "2020": 10572,
   "2021": 8809,
   "2022": 7794,
   "2023": 7978,
   "2024": 8190,
   "2025": 7525,
   "2026": 3662
  },
  "by_year_primary": {
   "2019": 11702,
   "2020": 10558,
   "2021": 8756,
   "2022": 7579,
   "2023": 7763,
   "2024": 7941,
   "2025": 7358,
   "2026": 3565
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250321",
   "reason": "Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Completed"
  },
  {
   "class": "Class III",
   "date": "20250116",
   "reason": "Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet",
   "firm": "Appco Pharma LLC",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20240621",
   "reason": "Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20161222",
   "reason": "Failed Tablet/Capsule Specifications: Some bottles contain  punctured, and/or clumped/melted capsules.",
   "firm": "Aurobindo Pharma USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20160719",
   "reason": "Failed Dissolution Specifications: out of specification dissolution results in retained samples",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20160719",
   "reason": "Failed Dissolution Specifications: out of specification dissolution results in retained samples",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20160325",
   "reason": "Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.",
   "firm": "Bryant Ranch Prepack Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130305",
   "reason": "Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 51,
  "nda": 4,
  "anda": 45,
  "first_approval": "19931228",
  "rems": false,
  "rems_last": "20120731",
  "labeling_supplements": 98,
  "labeling_recent": 7,
  "sponsors": [
   "ABON PHARMS LLC",
   "ADAPTIS",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "ALEMBIC PHARMS LTD",
   "ALKEM LABS LTD",
   "ALMATICA",
   "AMNEAL PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/28/1993"
 },
 "trials": {
  "total": 273,
  "completed": 184,
  "terminated": 23,
  "with_results": 83,
  "industry": 101,
  "phase3": 61,
  "results_share": 0.45108695652173914,
  "terminated_share": 0.08424908424908426
 },
 "pubmed": {
  "rct": 346,
  "meta": 51,
  "recent_rct": 25,
  "cochrane": [
   {
    "pmid": "26298465",
    "title": "Venlafaxine for neuropathic pain in adults",
    "year": "2015"
   },
   {
    "pmid": "25267891",
    "title": "Venlafaxine versus other anti-depressive agents for depression",
    "year": "2007"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 23086.43,
  "records": 10,
  "by_name": [
   [
    "Effexor",
    23086.43
   ]
  ],
  "names_checked": [
   "venlafaxine",
   "Effexor"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 6174532,
  "beneficiaries": 1164400,
  "spend": 160005291.84,
  "by_brand": [
   {
    "brand": "Venlafaxine HCl ER",
    "claims": 5423191,
    "per_claim": 21.853929528,
    "is_generic": false
   },
   {
    "brand": "Venlafaxine HCl",
    "claims": 731696,
    "per_claim": 23.170949219,
    "is_generic": true
   },
   {
    "brand": "Effexor XR",
    "claims": 16997,
    "per_claim": 1398.7430341,
    "is_generic": false
   },
   {
    "brand": "Venlafaxine Besylate ER",
    "claims": 2648,
    "per_claim": 286.53009819,
    "is_generic": false
   }
  ],
  "per_claim": 25.913752141862737
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Haematology",
  "names": [
   "duloxetine",
   "milnacipran",
   "venlafaxine"
  ],
  "reason": "Duloxetine, milnacipran and venlafaxine are serotonin and noradrenaline (norepinephrine) reuptake inhibitors (SNRIs) that, as well as provoking the adverse effects of SSRI antidepressants, carry a risk of cardiac disorders due to their noradrenergic activity, including hypertension, tachycardia, arrhythmias, and QT prolongation. Compared with SSRIs, venlafaxine carries a higher risk of withdrawal symptoms following discontinuation, and a higher risk of cardiac arrest in cases of overdose (Prescrire Int n\u00b0 131, 170, 206, 250, 270; Rev Prescrire n\u00b0 338; Interactions M\u00e9dicamenteuses Prescrire). D...",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "venlafaxine"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 18864,
  "fills": 6174532,
  "per_million": 3055.1303321450114,
  "ratio": 1.103353474711058,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 55,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "3,055 FDA reports naming it as the suspect drug per million Medicare fills, 1.1x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 57,
   "letter": "D",
   "why": [
    "346 randomized trials and 51 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "2 independent Cochrane review(s) exist",
    "Only 45% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 80,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 2 Class III across 45 generic makers (-7)",
    "7 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $23,086 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (45 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 68,
 "grade": "C",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are nausea, fatigue, headache. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}