{"id":"doconexent","rwe":[{"pmid":"40859213","year":"2025","title":"The mechanism of probiotics in pregnancy outcomes in overweight or obese pregnant women based on meta-analysis, network pharmacology and molecular docking.","finding":"","journal":"BMC pregnancy and childbirth","studyType":"Clinical Study"},{"pmid":"40380147","year":"2025","title":"Exploring causal associations between plasma metabolites and attention-deficit/hyperactivity disorder.","finding":"","journal":"BMC psychiatry","studyType":"Clinical Study"},{"pmid":"34650958","year":"2021","title":"Characterization of Phytochemicals in Ulva intestinalis L. and Their Action Against SARS-CoV-2 Spike Glycoprotein Receptor-Binding Domain.","finding":"","journal":"Frontiers in chemistry","studyType":"Clinical Study"},{"pmid":"33371199","year":"2020","title":"Grapefruit-Derived Micro and Nanovesicles Show Distinct Metabolome Profiles and Anticancer Activities in the A375 Human Melanoma Cell Line.","finding":"","journal":"Cells","studyType":"Clinical Study"},{"pmid":"29710507","year":"2018","title":"The ameliorative effect of Homalium nepalense on carbon tetrachloride-induced hepatocellular injury in rats.","finding":"","journal":"Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie","studyType":"Clinical Study"}],"_fda":{"id":"973ff5d8-ba4b-4641-a3a0-3840e4630ce3","set_id":"038fe2e7-dc16-485c-b5fb-746db7231347","openfda":{"nui":["N0000193618","M0001797","M0003153","N0000175901","M0022797","N0000175952","M0022794","N0000175951","N0000192800","N0000005657","N0000175452"],"unii":["WR1WPI7EW8","PQ6CK8PD0R","SY7Q814VUP","1C6V77QF41","P6YC3EG204","ZAD9OKH9JC","R5L488RY0Q","935E97BOY8","I38ZP9992A","KV2JZ1BI6Z"],"route":["ORAL"],"spl_id":["973ff5d8-ba4b-4641-a3a0-3840e4630ce3"],"brand_name":["PNV-DHA"],"spl_set_id":["038fe2e7-dc16-485c-b5fb-746db7231347"],"package_ndc":["42192-321-30"],"product_ndc":["42192-321"],"generic_name":["ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Ascorbic Acid [CS]","Calcium [CS]","Vitamin D [CS]","Vitamin B 12 [CS]","Vitamin B 6 [Chemical/Ingredient]","Analogs/Derivatives [Chemical/Ingredient]"],"substance_name":[".ALPHA.-TOCOPHEROL ACETATE, DL-","ASCORBIC ACID","CALCIUM","CHOLECALCIFEROL","CYANOCOBALAMIN","DOCONEXENT","FERROUS FUMARATE","FOLIC ACID","MAGNESIUM","PYRIDOXINE"],"pharm_class_epc":["Vitamin C [EPC]","Calcium [EPC]","Vitamin D [EPC]","Vitamin B12 [EPC]","Vitamin B6 Analog [EPC]"],"manufacturer_name":["Acella Pharmaceuticals, LLC"],"is_original_packager":[true]},"version":"3","warnings":["WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding."],"description":["DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque and imprinted with “BP 321” on one side. Supplement Facts Serving Size 1 Tablet Amount Per Serving % DV %DV for Pregnant or Lactating Women Vitamin C 85 mg 142% 142% Vitamin D 3 200 IU 50% 50% Vitamin E 10 IU 33% 33% Vitamin D 6 25 mg 1250% 1000% Folate 1 mg 250% 125% (L-methylfolate calcium 676 mcg (as Xolafin-B™ Percent Daily Values are based on a 2000 calorie diet ) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg) Vitamin B 12 12 mcg 200% 150% Calcium 140 mg 14% 11% Iron (ferrous fumarate) 27 mg 150% 150% Magnesium 45 mg 11% 10% Docosahexaenoic Acid (DHA) (from omega-3 fatty acids) 300 mg Daily Value (DV) not established OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3. INDICATIONS: PNV-DHA is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"precautions":["PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"how_supplied":["HOW SUPPLIED: PNV-DHA is supplied in child-resistant bottles of 30 softgels (NDC# 42192-321-30). Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]"],"boxed_warning":["WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"effective_time":"20240115","adverse_reactions":["ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"contraindications":["CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description_table":["<table width=\"75%\" border=\"Box\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"20%\" align=\"right\" valign=\"top\"/><col width=\"20%\" align=\"right\" valign=\"top\"/><col width=\"20%\" align=\"right\" valign=\"top\"/><tbody><tr align=\"center\" valign=\"top\"><th colspan=\"4\" align=\"center\">Supplement Facts</th></tr><tr><th align=\"left\" styleCode=\"Botrule\">Serving Size 1 Tablet</th><th align=\"left\" styleCode=\" Botrule\"/><th align=\"left\" styleCode=\" Botrule\"/><th align=\"left\" styleCode=\" Botrule\"/></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\"><content styleCode=\"bold\">Amount Per  Serving </content></td><td align=\"left\"/><td align=\"center\"><content styleCode=\"bold\">% DV </content></td><td align=\"center\"><content styleCode=\"bold\">%DV for Pregnant  or Lactating  Women </content></td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\">Vitamin C</td><td align=\"center\">85 mg</td><td align=\"center\">142%</td><td align=\"center\">142%</td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\">Vitamin D <sub>3</sub></td><td align=\"center\">200 IU</td><td align=\"center\">50%</td><td align=\"center\">50%</td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\">Vitamin E</td><td align=\"center\">10 IU</td><td align=\"center\">33%</td><td align=\"center\">33%</td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\">Vitamin D <sub>6</sub></td><td align=\"center\">25 mg</td><td align=\"center\">1250%</td><td align=\"center\">1000%</td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\">Folate</td><td align=\"center\">1 mg</td><td align=\"center\">250%</td><td align=\"center\">125%</td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td colspan=\"4\" align=\"left\" valign=\"middle\">(L-methylfolate calcium 676 mcg (as Xolafin-B&#x2122; <footnote ID=\"FN1\">Percent Daily Values are based on a 2000 calorie diet</footnote>)  molar equivalent to 600 mcg of Folic Acid) </td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td colspan=\"4\" align=\"left\" valign=\"middle\">(folic acid, USP 400 mcg)</td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\">Vitamin B <sub>12</sub></td><td align=\"center\">12 mcg</td><td align=\"center\">200%</td><td align=\"center\">150%</td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\">Calcium</td><td align=\"center\">140 mg</td><td align=\"center\">14%</td><td align=\"center\">11%</td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\">Iron (ferrous fumarate)</td><td align=\"center\">27 mg</td><td align=\"center\">150%</td><td align=\"center\">150%</td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\">Magnesium</td><td align=\"center\">45 mg</td><td align=\"center\">11%</td><td align=\"center\">10%</td></tr><tr align=\"left\" styleCode=\"Botrule\" valign=\"bottom\"><td align=\"left\" valign=\"bottom\">Docosahexaenoic Acid (DHA)  (from omega-3 fatty acids) </td><td align=\"center\" valign=\"top\">300 mg</td><td align=\"center\" valign=\"middle\"><footnote ID=\"FN2\">Daily Value (DV) not established</footnote></td><td align=\"center\" valign=\"middle\"><footnoteRef IDREF=\"FN2\"/></td></tr></tbody></table>"],"inactive_ingredient":["OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3."],"indications_and_usage":["INDICATIONS: PNV-DHA is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation."],"spl_unclassified_section":["Rx Only","KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.","All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.","MANUFACTURED FOR: Acella Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802 Rev. 04/10v6 *Xolafin-B™ is a trademark of Acella Pharmaceuticals, LLC"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician."],"spl_product_data_elements":["PNV-DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent CARNAUBA WAX CORN OIL LECITHIN, SOYBEAN GELATIN GLYCERIN WATER TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 3 ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- PYRIDOXINE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CALCIUM FERROUS FUMARATE FERROUS CATION MAGNESIUM MAGNESIUM DOCONEXENT DOCONEXENT BP;321"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets NDC 42192-321-30 PNV-DHA Rx Prenatal Vitamin and DHA Rx Only 30 Softgels Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - Film Coated Tablets"]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Free fatty acid receptor 1","category":"target"},{"label":"FFAR1","category":"gene"},{"label":"OXER1","category":"gene"},{"label":"RXRA","category":"gene"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Active","category":"status"},{"label":"Breastfeeding (mother)","category":"indication"},{"label":"Pregnancy, function","category":"indication"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"safetySignals":[{"date":"","signal":"PREMATURE DELIVERY","source":"FDA FAERS","actionTaken":"22 reports"},{"date":"","signal":"MATERNAL EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"8 reports"},{"date":"","signal":"EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"FOETAL EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"5 reports"}],"commonSideEffects":[{"effect":"Skin ailments","drugRate":"reported","severity":"unknown"},{"effect":"Gastrointestinal complaints","drugRate":"reported","severity":"unknown"},{"effect":"Glucose abnormalities","drugRate":"reported","severity":"unknown"},{"effect":"Visual problems","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Pregnancy":"The safety of phytosterols has not been studied in pregnant or breastfeeding women. There is no evidence that dietary intakes of naturally occurring phytosterols, such as those consumed by vegetarian women, adversely affects pregnancy or lactation.","Paediatric use":"Not for pediatric use."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DOCONEXENT","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:47:41.408165+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:47:46.720239+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DOCONEXENT","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:47:47.043867+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:47:39.963869+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:47:39.963904+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:47:39.963910+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:47:48.516824+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL367149/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:47:47.761766+00:00"}},"allNames":"efalex","offLabel":[],"synonyms":["docosahexaenoic acid","doconexent","cervonic acid","efalex"],"timeline":[],"approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Efalex","ecosystem":[{"indication":"Breastfeeding (mother)","otherDrugs":[{"name":"ascorbic acid","slug":"ascorbic-acid","company":""},{"name":"calcium 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RXR-alpha","protein":"Retinoic acid receptor RXR-alpha"},{"gene":"CYP19A1","source":"DrugCentral","target":"Aromatase","protein":"Aromatase"}],"modality":"Small Molecule","drugClass":"Vitamin C [EPC]","explanation":"","oneSentence":"","technicalDetail":"Efalex acts as a selective agonist of the free fatty acid receptor 1 (FFAR1), modulating the downstream signaling pathways involved in fatty acid metabolism and energy homeostasis."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4289","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DOCONEXENT","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DOCONEXENT","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:44:26.606839","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:47:50.532380+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"aminoglutethimide","drugSlug":"aminoglutethimide","fdaApproval":"1980-10-29","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"anastrozole","drugSlug":"anastrozole","fdaApproval":"1995-12-27","genericCount":19,"patentStatus":"Off-patent — generic 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