{
 "query": "desvenlafaxine",
 "ingredient": "desvenlafaxine",
 "slug": "desvenlafaxine",
 "rxcui": "734064",
 "brands": [
  "Pristiq",
  "Khedezla"
 ],
 "names": [
  "desvenlafaxine",
  "desvenlafaxine fumarate monohydrate",
  "desvenlafaxine succinate"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 44
  },
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ] . PRISTIQ is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. \u2022 Increased the risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants ( 5.1 ). \u2022 Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). \u2022 PRISTIQ is not approved for use in pediat...",
  "indications_and_usage": "is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14) ] . PRISTIQ is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) ( 1 ).",
  "contraindications": "\u2022 Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the PRISTIQ formulation. Angioedema has been reported in patients treated with PRISTIQ [see Adverse Reactions (6.1) ] . \u2022 The use of MAOIs intended to treat psychiatric disorders with PRISTIQ or within 7 days of stopping treatment with PRISTIQ is contraindicated because of an increased risk of serotonin syndrome. The use of PRISTIQ within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.7) and Warnings and Precautions (5.2) ]. \u2022 Starting PRISTIQ in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.8) and Warnings and Precautions (5.2) ]. \u2022 Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ formulation ( 4 ). \u2022 Serotonin Syndrome and MAOIs : Do not use MAOIs intended to treat psychiatric disorders with PRISTIQ or within 7 days of stopping treatment with PRISTIQ. Do not use PRISTIQ within 14 days of stopping an M...",
  "warnings_and_cautions": "\u2022 Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue PRISTIQ and serotonergic agents and initiate supportive treatment ( 5.2 ). \u2022 Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment ( 5.3 ). \u2022 Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.4 ). \u2022 Angle Closure Glaucoma: Avoid use of antidepressants, including PRISTIQ, in patients with untreated anatomically narrow angles treated ( 5.5 ). \u2022 Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania ( 5.6 ). \u2022 Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms ( 5.7 ). \u2022 Seizure: Can occur. Use cautiously in patients with seizure disorder ( 5.8 ). \u2022 Hyponatremia: Can occur in association with SIADH ( 5.9 ). \u2022 Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur ( 5.10 ). \u2022 Sexual Dysfunction: PRISTIQ may cause symptoms of sexual dysfuncti...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the label. \u2022 Hypersensitivity [see Contraindications (4) ] \u2022 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see Warnings and Precautions (5.1) ] \u2022 Serotonin Syndrome [see Warnings and Precautions (5.2) ] \u2022 Elevated Blood Pressure [see Warnings and Precautions (5.3) ] \u2022 Increased Risk of Bleeding [see Warnings and Precautions (5.4) ] \u2022 Angle Closure Glaucoma [see Warnings and Precautions (5.5) ] \u2022 Activation of Mania/Hypomania [see Warnings and Precautions (5.6) ] \u2022 Discontinuation Syndrome [see Warnings and Precautions (5.7) ] \u2022 Seizure [see Warnings and Precautions (5.8) ] \u2022 Hyponatremia [see Warnings and Precautions (5.9) ] \u2022 Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions (5.10) ] \u2022 Sexual Dysfunction [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence \u22655% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance PRISTIQ is not a controlled substance.",
  "controlled_substance": "9.1 Controlled Substance PRISTIQ is not a controlled substance.",
  "recent_major_changes": "",
  "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 Advise patients taking PRISTIQ not to use concomitantly other products containing desvenlafaxine or venlafaxine. Healthcare professionals should instruct patients not to take PRISTIQ with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping PRISTIQ before starting an MAOI [see Contraindications (4) ] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of PRISTIQ with other serotonergic agents (including triptans, tricyclic antidepressants, opioids, lithium, amphetamines, tryptophan, buspirone, and St. John's Wort supplements) [see Warnings and Precautions (5.2) ] . Elevated Blood Pressure Advise patients that they should have regular monitoring of blood pressure when taking PRISTIQ [see Wa...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 6/2025 MEDICATION GUIDE PRISTIQ \u00ae (pris- TEEK ) (desvenlafaxine) extended-release tablets What is the most important information I should know about PRISTIQ? PRISTIQ can cause serious side effects, including: \u2022 Increased risk of suicidal thoughts or actions in some children and young adults within the first few months of treatment. PRISTIQ is not for use in children. \u2022 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? o 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 or when the dose is changed. o Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. o Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider right away if you have any of the fo...",
  "clinical_studies": "Major Depressive Disorder The efficacy of PRISTIQ as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies (at doses of 50 mg per day to 400 mg per day) in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder. In the first study, patients received 100 mg (n = 114), 200 mg (n = 116), or 400 mg (n = 113) of PRISTIQ once daily, or placebo (n = 118). In a second study, patients received either 200 mg (n = 121) or 400 mg (n = 124) of PRISTIQ once daily, or placebo (n = 124). In two additional studies, patients received 50 mg (n = 150 and n = 164) or 100 mg (n = 147 and n = 158) of PRISTIQ once daily, or placebo (n = 150 and n = 161). PRISTIQ showed superiority over placebo as measured by improvement in the 17-item Hamilton Rating Scale for Depression (HAM-D 17 ) total score in four studies and overall improvement, as measured by the Clinical Global Impressions Scale - Improvement (CGI-I), in three of the four studies. In studies directly comparing 50 mg per day and 100 mg per day there was no suggestion of a greater effect with the higher d...",
  "brand_name": "Pristiq Extended-Release",
  "manufacturer": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
  "application_number": "NDA021992",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260428",
  "set_id": "0f43610c-f290-46ea-d186-4f998ed99fce",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 18368,
  "serious": 9143,
  "death": 759,
  "hospitalization": 3138,
  "primary_suspect": 18280,
  "top_reactions": [
   [
    "Drug Ineffective",
    2350
   ],
   [
    "Nausea",
    1299
   ],
   [
    "Anxiety",
    1174
   ],
   [
    "Headache",
    1097
   ],
   [
    "Depression",
    1070
   ],
   [
    "Fatigue",
    1053
   ],
   [
    "Dizziness",
    1031
   ],
   [
    "Off Label Use",
    967
   ],
   [
    "Feeling Abnormal",
    948
   ],
   [
    "Malaise",
    801
   ],
   [
    "Insomnia",
    757
   ],
   [
    "Pain",
    749
   ],
   [
    "Suicidal Ideation",
    642
   ],
   [
    "Withdrawal Syndrome",
    600
   ],
   [
    "Diarrhoea",
    584
   ]
  ],
  "by_year": {
   "2019": 1644,
   "2020": 1773,
   "2021": 1274,
   "2022": 1382,
   "2023": 1173,
   "2024": 1080,
   "2025": 1130,
   "2026": 537
  },
  "by_year_primary": {
   "2019": 1641,
   "2020": 1765,
   "2021": 1261,
   "2022": 1363,
   "2023": 1146,
   "2024": 1076,
   "2025": 1126,
   "2026": 527
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140416",
   "reason": "Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.",
   "firm": "Pfizer Us Pharmaceutical Group",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 15,
  "nda": 3,
  "anda": 11,
  "first_approval": "20080229",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 42,
  "labeling_recent": 6,
  "sponsors": [
   "ACTAVIS LABS FL",
   "ALEMBIC",
   "ALEMBIC PHARMS LTD",
   "ANCHEN PHARMS",
   "HIKMA",
   "LUPIN",
   "MACLEODS PHARMS",
   "OSMOTICA PHARM CORP"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/29/2008"
 },
 "trials": {
  "total": 99,
  "completed": 74,
  "terminated": 8,
  "with_results": 46,
  "industry": 75,
  "phase3": 37,
  "results_share": 0.6216216216216216,
  "terminated_share": 0.08080808080808081
 },
 "pubmed": {
  "rct": 59,
  "meta": 10,
  "recent_rct": 6,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "desvenlafaxine",
   "Pristiq",
   "Khedezla"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 976313,
  "beneficiaries": 187135,
  "spend": 69006519.08,
  "by_brand": [
   {
    "brand": "Desvenlafaxine Succinate ER",
    "claims": 958249,
    "per_claim": 63.390907322,
    "is_generic": false
   },
   {
    "brand": "Desvenlafaxine ER",
    "claims": 10502,
    "per_claim": 209.92738431,
    "is_generic": false
   },
   {
    "brand": "Pristiq",
    "claims": 7562,
    "per_claim": 801.05635282,
    "is_generic": false
   }
  ],
  "per_claim": 70.68073361719038
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2729,
  "fills": 976313,
  "per_million": 2795.210142648925,
  "ratio": 1.009483880602216,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,795 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.5x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 47,
   "letter": "F",
   "why": [
    "59 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 11 generic makers (-1)",
    "6 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 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 (11 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "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, anxiety, headache. How would we recognize and handle those?",
  "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.)"
 ]
}