{
 "query": "bupropion",
 "ingredient": "bupropion",
 "slug": "bupropion",
 "rxcui": "42347",
 "brands": [
  "Aplenzin",
  "Forfivo",
  "Wellbutrin"
 ],
 "names": [
  "bupropion",
  "bupropion hydrobromide",
  "bupropion hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 232
  },
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects 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 )] . NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation [see Warnings and Precautions ( 5.2 )]. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion trea...",
  "indications_and_usage": "Bupropion hydrochloride extended-release tablets, USP (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM ) . The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14 )] . The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14 )] . \u2022 Bupropion hydrochloride extended-release tablets, USP (SR), are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )",
  "contraindications": "\u2022 Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. \u2022 Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release formulation of bupropion [see Warnings and Precautions ( 5.3 )]. \u2022 Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.3 )] . \u2022 The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (SR) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (SR) is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (SR) are used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets (SR) within 14 days of discontinuing treatment w...",
  "warnings_and_cautions": "\u2022 Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 400 mg. Discontinue if seizure occurs. ( 4 , 5.3 , 7.3 ) \u2022 Hypertension: Bupropion hydrochloride extended-release tablets (SR) can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment. ( 5.4 ) \u2022 Activation of mania/hypomania: Screen patients for bipolar disorder and monitor for these symptoms. ( 5.5 ) \u2022 Psychosis and other neuropsychiatric reactions: Instruct patients to contact a healthcare professional if such reactions occur. ( 5.6 ) \u2022 Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.7 ) 5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with MDD, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the labeling: \u2022 Suicidal thoughts and behaviors in adolescents and young adults [see Boxed Warning , Warnings and Precautions ( 5.1 )] \u2022 Neuropsychiatric symptoms and suicide risk in smoking cessation treatment [see Boxed Warning , Warnings and Precautions ( 5.2 )] \u2022 Seizure [see Warnings and Precautions ( 5.3 )] \u2022 Hypertension [see Warnings and Precautions ( 5.4 )] \u2022 Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )] \u2022 Psychosis and other neuropsychiatric reactions [see Warnings and Precautions ( 5.6 )] \u2022 Angle-closure glaucoma [see Warnings and Precautions ( 5.7 )] \u2022 Hypersensitivity reactions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence greater than or equal to 5% and greater than or equal to 2% more than placebo rate) are: headache, dry mouth, nausea, insomnia, dizziness, pharyngitis, constipation, agitation, anxiety, abdominal pain, tinnitus, tremor, palpitation, myalgia, sweating, rash, and anorexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis Laboratories FL, Inc. at 1-800-272-5525 or FDA at 1-800-FDA-1088 or Error! H...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Bupropion is not a controlled substance. 9.2 Abuse Humans: Controlled clinical trials conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed subjects showed some increase in motor activity and agitation/excitement, often typical of central stimulant activity. In a population of individuals experienced with drugs of abuse, a single dose of 400 mg of bupropion produced mild amphetamine\u2011like activity as compared with placebo on the Morphine\u2011Benzedrine Subscale of the Addiction Research Center Inventories (ARCI) and a score greater than placebo but less than 15 mg of the Schedule II stimulant dextroamphetamine on the Liking Scale of the ARCI. These scales measure general feelings of euphoria and drug liking which are often associated with abuse potential. Findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs. Nonetheless, evidence from single\u2011dose trials does suggest that the recommended daily dosage of bupropion when administered orally in divided doses is not likely to be significantly reinforcing to amphetamine or CNS stimulant abusers. However, higher doses (that cou...",
  "controlled_substance": "9.1 Controlled Substance Bupropion is not a controlled substance.",
  "recent_major_changes": "RECENT MAJOR CHANGES Warnings and Precautions, Angle-Closure Glaucoma ( 5.7 ) 08/2014",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Error! Hyperlink reference not valid. ) . Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with bupropion hydrochloride extended-release tablets (SR) and counsel them in its appropriate use. A patient Medication Guide about \u201cAntidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions,\u201d \u201cQuitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions,\u201d and \u201cWhat Other Important Information Should I Know About Bupropion Hydrochloride Extended-release Tablets (SR)?\u201d is available for bupropion hydrochloride extended-release tablets (SR). Instruct patients, their families, and their caregivers to read the Medication Guide and assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Advise patients regarding the following issues and to alert their prescri...",
  "spl_medguide": "MEDICATION GUIDE Bupropion Hydrochloride (byoo-PRO-pee-on HYE-droe-KLOR-ide), USP (SR) Sustained-Release Tablets Read this Medication Guide carefully before you start taking bupropion hydrochloride extended-release tablets (SR) and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about bupropion hydrochloride extended-release tablets (SR), ask your healthcare provider or pharmacist. IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled \u201cWhat Other Important Information Should I Know About Bupropion Hydrochloride Extended-release Tablets (SR)?\u201d Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of suicidal ...",
  "clinical_studies": "The efficacy of the immediate\u2011release formulation of bupropion in the treatment of major depressive disorder was established in two 4\u2011week, placebo\u2011controlled trials in adult inpatients with MDD (Trials 1 and 2 in Table 6) and in one 6\u2011week, placebo\u2011controlled trial in adult outpatients with MDD (Trial 3 in Table 6). In the first trial, the dose range of bupropion was 300 mg to 600 mg per day administered in divided doses; 78% of subjects were treated with doses of 300 mg to 450 mg per day. This trial demonstrated the effectiveness of the immediate\u2011release formulation of bupropion by the Hamilton Depression Rating Scale (HDRS) total score, the HDRS depressed mood item (item 1), and the Clinical Global Impressions severity score (CGI-S). The second trial included 2 doses of the immediate\u2011release formulation of bupropion (300 and 450 mg per day) and placebo. This trial demonstrated the effectiveness of the immediate\u2011release formulation of bupropion, but only at the 450\u2011mg-per-day dose. The efficacy results were significant for the HDRS total score and the CGI-S score, but not for HDRS item 1. In the third trial, outpatients were treated with 300 mg per day of the immediate\u2011release fo...",
  "brand_name": "Bupropion Hydrochloride SR",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA079095",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20220501",
  "set_id": "13770e60-117c-4814-93bb-9bc41a042a20",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 110259,
  "serious": 65485,
  "death": 11532,
  "hospitalization": 27344,
  "primary_suspect": 109605,
  "top_reactions": [
   [
    "Drug Ineffective",
    9967
   ],
   [
    "Fatigue",
    8130
   ],
   [
    "Nausea",
    7634
   ],
   [
    "Headache",
    7174
   ],
   [
    "Depression",
    6320
   ],
   [
    "Off Label Use",
    6245
   ],
   [
    "Pain",
    5461
   ],
   [
    "Anxiety",
    5404
   ],
   [
    "Completed Suicide",
    5079
   ],
   [
    "Dizziness",
    4814
   ],
   [
    "Toxicity To Various Agents",
    4675
   ],
   [
    "Diarrhoea",
    4393
   ],
   [
    "Insomnia",
    3555
   ],
   [
    "Vomiting",
    3491
   ],
   [
    "Dyspnoea",
    3490
   ]
  ],
  "by_year": {
   "2019": 10697,
   "2020": 10132,
   "2021": 9245,
   "2022": 8967,
   "2023": 8535,
   "2024": 8941,
   "2025": 8424,
   "2026": 4711
  },
  "by_year_primary": {
   "2019": 10688,
   "2020": 10097,
   "2021": 9168,
   "2022": 8841,
   "2023": 8397,
   "2024": 8829,
   "2025": 8320,
   "2026": 4674
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20231122",
   "reason": "Failed Dissolution Specifications",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20231004",
   "reason": "Failed Dissolution Specifications",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230509",
   "reason": "Failed Dissolution Specifications; during stability testing",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20221227",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "Amerisource Health Services LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20220429",
   "reason": "Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20220429",
   "reason": "Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180906",
   "reason": "Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.",
   "firm": "InvaGen Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180315",
   "reason": "Failed Dissolution Specifications; during stability testing",
   "firm": "InvaGen Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180315",
   "reason": "Failed Dissolution Specifications; during stability testing",
   "firm": "InvaGen Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20161220",
   "reason": "Failed Dissolution Specifications; 18 month stability time point",
   "firm": "Sun Pharmaceutical Industries, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20160913",
   "reason": "Failed Dissolution Specifications",
   "firm": "Sun Pharmaceutical Industries, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 14,
 "drugsfda": {
  "applications": 71,
  "nda": 6,
  "anda": 64,
  "first_approval": "19851230",
  "rems": false,
  "rems_last": "20170504",
  "labeling_supplements": 164,
  "labeling_recent": 18,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS LABS FL INC",
   "ALEMBIC",
   "ANBISON LAB",
   "ANNORA PHARMA",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "AUROBINDO PHARMA USA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/30/1985"
 },
 "trials": {
  "total": 509,
  "completed": 368,
  "terminated": 48,
  "with_results": 184,
  "industry": 173,
  "phase3": 98,
  "results_share": 0.5,
  "terminated_share": 0.09430255402750491
 },
 "pubmed": {
  "rct": 368,
  "meta": 55,
  "recent_rct": 38,
  "cochrane": [
   {
    "pmid": "28965364",
    "title": "Bupropion for attention deficit hyperactivity disorder (ADHD) in adults",
    "year": "2017"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 219060.5,
  "records": 9138,
  "by_name": [
   [
    "Aplenzin",
    202787.35
   ],
   [
    "Wellbutrin",
    16273.15
   ]
  ],
  "names_checked": [
   "bupropion",
   "Aplenzin",
   "Forfivo",
   "Wellbutrin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 9815715,
  "beneficiaries": 2224994,
  "spend": 319023550.7,
  "by_brand": [
   {
    "brand": "Bupropion XL",
    "claims": 6831216,
    "per_claim": 24.684360427,
    "is_generic": false
   },
   {
    "brand": "Bupropion HCl SR",
    "claims": 2256886,
    "per_claim": 20.399069142,
    "is_generic": false
   },
   {
    "brand": "Bupropion HCl",
    "claims": 702514,
    "per_claim": 24.248501866,
    "is_generic": true
   },
   {
    "brand": "Wellbutrin XL",
    "claims": 18653,
    "per_claim": 4390.3850362,
    "is_generic": false
   },
   {
    "brand": "Wellbutrin SR",
    "claims": 6091,
    "per_claim": 852.98527007,
    "is_generic": false
   },
   {
    "brand": "Forfivo XL",
    "claims": 355,
    "per_claim": 666.70940845,
    "is_generic": false
   }
  ],
  "per_claim": 32.501305376123895
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20161216",
   "title": "FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm532221.htm",
   "kind": "drug",
   "matched": "bupropion"
  }
 ],
 "settlements": [
  {
   "year": 2012,
   "company": "GlaxoSmithKline",
   "amount_usd": 3000000000.0,
   "amount_text": "$3 billion ($1B criminal, $2B civil)",
   "violations": "Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program",
   "products": "Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/2012/July/12-civ-842.html",
    "https://web.archive.org/web/20240714112314/https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report"
   ],
   "matched": "wellbutrin"
  }
 ],
 "prescrire": {
  "section": "Smoking cessation",
  "names": [
   "bupropion"
  ],
  "reason": "Bupropion , a substance that is chemically related to certain amphetamines, is authorised for smoking cessation. It is no more effective than nicotine , but can cause neuropsychiatric disorders (including aggressiveness, depression and suicidal thoughts), potentially severe allergic reactions (including angioedema and Stevens-Johnson syndrome), addiction, and congenital heart defects in children exposed to the drug in utero ( Prescrire Int n\u00b0 126, 131; Rev Prescrire n\u00b0 221, 377). When a drug is needed to help with smoking cessation, nicotine is a better choice, despite its limitations. Urology",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "bupropion"
 },
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "bupropion",
  "matched": "bupropion",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 21823,
  "fills": 9815715,
  "per_million": 2223.2715599423987,
  "ratio": 0.8029295428344057,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 52,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-8)",
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "2,223 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 66,
   "letter": "C",
   "why": [
    "368 randomized trials and 55 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "1 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 10 Class III across 64 generic makers (-6)",
    "18 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": 50,
   "letter": "D",
   "why": [
    "Maker paid $3 billion ($1B criminal, $2B civil) in 2012 to settle federal allegations naming this drug (Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to) (-35)",
    "Pharma paid doctors $219,060 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (64 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 61,
 "grade": "D",
 "questions": [
  "In 2016 the FDA issued a safety communication about this drug (FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and ). Does that risk apply to me?",
  "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?",
  "The maker paid $3 billion in 2012 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "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 fatigue, nausea, 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.)"
 ]
}