{"format":"citation-manifest/v1","page":"https://screamcreamrx.com/monograph","claim_count":60,"claims":[{"id":"SCR-001","text":"No FDA-approved product named scream cream exists: an openFDA Drugs@FDA query for the ingredient name returns NOT_FOUND, and no arousal cream of any name is approved for female sexual arousal disorder.","source_url":"https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22scream+cream%22&limit=3","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SCR-002","text":"FDA states that compounded drugs are not FDA-approved and that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SCR-003","text":"CareFirst Specialty Pharmacy advertises its Scream Cream with six active ingredients: sildenafil, aminophylline, L-arginine, pentoxifylline, ergoloid mesylate and phentolamine mesylate.","source_url":"https://cfspharmacy.pharmacy/scream-cream/","grade":"market-documentation","grade_label":"Market documentation"},{"id":"SCR-004","text":"Kare Rx advertises its Scream Cream as a three-ingredient blend: theophylline 3%, arginine 6% and sildenafil 2%, dispensed in a 30-gram metered pump.","source_url":"https://www.kare-rx.com/products/scream-cream","grade":"market-documentation","grade_label":"Market documentation"},{"id":"SCR-005","text":"The same Kare Rx page also sells a sildenafil-free variant under the name Climax Cream: theophylline 3%, arginine 6%, ergoloid mesylate 0.05% and pentoxifylline 5%.","source_url":"https://www.kare-rx.com/products/scream-cream","grade":"market-documentation","grade_label":"Market documentation"},{"id":"SCR-006","text":"Kare Rx explicitly offers custom strengths of its arousal cream: the order page reads 'Don't see your strength? Request a custom' formulation, meaning even one pharmacy's formula is negotiable per prescription.","source_url":"https://www.kare-rx.com/products/scream-cream","grade":"market-documentation","grade_label":"Market documentation"},{"id":"SCR-007","text":"Across the two pharmacies this site verified directly, three distinct formulas are documented, ranging from three to six active ingredients, with a combined ingredient set of seven drugs: sildenafil, aminophylline, theophylline, L-arginine, pentoxifylline, ergoloid mesylates and phentolamine. Formula count and ingredient set are computed from the documented-formula table rendered on this site.","source_url":"https://www.kare-rx.com/products/scream-cream","grade":"derived","grade_label":"Derived from cited data"},{"id":"SCR-008","text":"Sildenafil's FDA-approved products are oral (56 product records) and intravenous (2) only; no topical sildenafil product of any kind is approved.","source_url":"https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22sildenafil+citrate%22&count=products.route.exact","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SCR-009","text":"Alprostadil's FDA-approved products are injectable (7 product records) and urethral (1) only; the alprostadil creams tested for female arousal were never approved in the United States.","source_url":"https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22alprostadil%22&count=products.route.exact","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SCR-016","text":"Zero of the seven ingredients documented across verified scream cream formulas has an FDA-approved topical form. Count computed from the approved-topical-form column of the ingredient-evidence table rendered on this site (7 rows, 0 Yes entries).","source_url":"https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22sildenafil+citrate%22&count=products.route.exact","grade":"derived","grade_label":"Derived from cited data"},{"id":"SCR-017","text":"The Viagra label indicates sildenafil for the treatment of erectile dysfunction and contraindicates it with nitric oxide donors such as organic nitrates or nitrites in any form, because sildenafil was shown to potentiate the hypotensive effect of nitrates; guanylate cyclase stimulators such as riociguat are also contraindicated.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22VIAGRA%22&limit=1","grade":"fda-label","grade_label":"FDA label"},{"id":"SCR-018","text":"For the approved oral form, the Viagra label reports rapid absorption with mean absolute bioavailability of 41% (range 25 to 63%) and median time to peak of 60 minutes fasted; these are oral numbers, and no equivalent published figures exist for vulvar application of a compounded cream.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22VIAGRA%22&limit=1","grade":"fda-label","grade_label":"FDA label"},{"id":"SCR-019","text":"There is no FDA-approved drug for female sexual arousal disorder itself: the 2024 topical sildenafil trial report states there are currently no FDA-approved treatments for FSAD, matching earlier reviews.","source_url":"https://europepmc.org/article/MED/39079074","grade":"review","grade_label":"Review or guideline"},{"id":"SCR-020","text":"No randomized trial of any scream cream blend as sold has ever been published: a PubMed search for the exact phrase returns 4 records (food science, dentistry, linguistics and a cold-sensor commentary), none about the compounded arousal cream and none a clinical trial.","source_url":"https://pubmed.ncbi.nlm.nih.gov/?term=%22scream+cream%22","grade":"bibliographic","grade_label":"Bibliographic record"},{"id":"SCR-021","text":"Aminophylline and theophylline, the methylxanthine base of most scream cream recipes, have zero published studies for female sexual arousal: the PubMed search for either drug with the phrase returns no records.","source_url":"https://pubmed.ncbi.nlm.nih.gov/?term=%28aminophylline+OR+theophylline%29+AND+%22female+sexual+arousal%22","grade":"bibliographic","grade_label":"Bibliographic record"},{"id":"SCR-024","text":"The largest trial of any topical arousal cream ingredient is the 2024 phase 2b RESPOND study of investigational sildenafil cream 3.6% (NCT04948151): 200 premenopausal women with FSAD randomized 1:1 to sildenafil or placebo cream for 12 weeks, with co-primary endpoints of SFQ28 Arousal Sensation and FSDS-DAO question 14.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11250102/","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-025","text":"In the RESPOND intention-to-treat population there were no statistically significant differences between sildenafil cream and placebo cream on the co-primary or secondary efficacy endpoints.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11250102/","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-026","text":"In an exploratory post hoc subset of RESPOND (women whose enrollment diagnosis was FSAD with or without decreased desire, excluding concomitant orgasmic dysfunction), sildenafil cream improved arousal sensation (least squares mean +2.03, SE 0.62) versus placebo (+0.08, SE 0.71), P=.04, with reduced distress on FSDS-DAO questions 3, 5 and 10 (all P<=.04).","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11250102/","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-027","text":"Topical sildenafil cream 3.6% was well tolerated in RESPOND: 78 adverse events in 29 of 99 sildenafil users versus 65 in 28 of 94 placebo users (P=.76), all mild or moderate, with application-site discomfort the most common treatment-related event in both arms; 4 versus 3 participants discontinued for application-site discomfort.","source_url":"https://europepmc.org/article/MED/39079074","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-028","text":"Sexual partners were systematically followed in the topical sildenafil trial: 9 adverse events among 7 of 91 partners exposed to sildenafil cream versus 4 among 4 of 84 exposed to placebo (P=.54), across 1,357 and 1,160 product-use sexual experiences respectively.","source_url":"https://europepmc.org/article/MED/39079074","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-029","text":"The RESPOND publications are industry-run: the study was conducted by Dare Bioscience under an FDA investigational new drug application, and the authors of the efficacy and subset papers are largely company employees. This is disclosed in the papers' conflict statements.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11576099/","grade":"bibliographic","grade_label":"Bibliographic record"},{"id":"SCR-030","text":"In pre-planned subsets of the topical sildenafil trial, age group and hormonal-contraception use did not significantly affect the co-primary endpoints (P values >0.11); the study population was primarily educated non-Hispanic White women.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11576099/","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-031","text":"An earlier crossover trial of the same concept (SST-6007 topical sildenafil cream, NCT02570282) completed in July 2017 with 31 participants; no results were ever posted to the registry and no publication is indexed in PubMed as of 2026-08-14.","source_url":"https://clinicaltrials.gov/study/NCT02570282","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SCR-032","text":"The RESPOND registry record (NCT04948151) has not been updated since 2021-07-01 and still shows overall status UNKNOWN with no results posted, even though results appeared in journals in 2024; registry hygiene in this field is poor.","source_url":"https://clinicaltrials.gov/study/NCT04948151","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SCR-033","text":"The largest oral sildenafil trial in women with sexual dysfunction including FSAD (781 randomized: 577 estrogenized, 204 estrogen-deficient; 10 to 100 mg) found differences between sildenafil and placebo were not significant for any patient or partner endpoint.","source_url":"https://europepmc.org/article/MED/12150499","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-034","text":"In 53 women aged 22 to 28 with arousal disorder (51 completing a double-blind crossover), oral sildenafil 25 and 50 mg improved arousal and orgasm versus placebo (P<0.001), with fantasies, intercourse frequency and enjoyment also improving (P<0.05).","source_url":"https://europepmc.org/article/MED/11426898","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-035","text":"In 202 hormonally screened postmenopausal women with FSAD, oral sildenafil improved genital sensation (p=0.017) and satisfaction with intercourse and foreplay (p=0.015); women with FSAD and no concomitant low desire improved on 5 of 6 index items (p<0.02), while women with concomitant low desire showed no significant improvement.","source_url":"https://europepmc.org/article/MED/14634409","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-036","text":"In 98 premenopausal women whose depression was in remission on serotonin reuptake inhibitors but who had treatment-associated sexual dysfunction, oral sildenafil (50 to 100 mg as needed) outperformed placebo on the primary global sexual-function score (mean end point difference 0.8, 95% CI 0.6 to 1.0, P=.001).","source_url":"https://europepmc.org/article/MED/18647982","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-037","text":"In 12 healthy premenopausal women, a single 50 mg oral sildenafil dose significantly increased measured vaginal vasocongestion during erotic stimulation but produced no difference in subjective sexual arousal; women reported stronger arousal for whichever treatment they believed was sildenafil, and half guessed wrong.","source_url":"https://europepmc.org/article/MED/12150498","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-038","text":"In 34 estrogenized postmenopausal women with acquired genital arousal disorder and impaired orgasm, sildenafil improved neither arousal nor orgasm across the whole group; only the subgroup with low vaginal pulse amplitude showed benefit.","source_url":"https://europepmc.org/article/MED/14592587","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-039","text":"MRI measurement undermines the blood-flow premise: in 19 premenopausal women with FSAD, sildenafil did not increase clitoral engorgement beyond placebo (89% versus 84% responders at 60 minutes, P=0.3173), and most participants had normal engorgement to begin with, suggesting FSAD is not predominantly a disorder of genital engorgement.","source_url":"https://europepmc.org/article/MED/22620487","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-040","text":"In 129 women with arousal disorder after spinal cord injury, flexible-dose oral sildenafil showed no statistically significant difference from placebo on any efficacy measure; the authors called the result similar to other reports of a lack of clinically meaningful benefit in women.","source_url":"https://europepmc.org/article/MED/20733587","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-041","text":"Self-reported arousal difficulties affect up to 26% of American women, which is why arousal products find a market regardless of their evidence.","source_url":"https://europepmc.org/article/MED/19352396","grade":"review","grade_label":"Review or guideline"},{"id":"SCR-042","text":"The first published FSAD-cream pilot used alprostadil, not any scream cream ingredient: in 8 women, escalating intravaginal alprostadil doses improved patient-rated and physician-assessed arousal signs, with mild vaginal itching and burning; vaginal photoplethysmography could not detect the effect.","source_url":"https://europepmc.org/article/MED/11554216","grade":"human-trial","grade_label":"Human trial"},{"id":"SCR-043","text":"In the 94-woman US at-home RCT of alprostadil cream for FSAD, the primary endpoint (arousal success rate) was not different from placebo at p=0.05 for any of the three doses; only nonsignificant dose-related trends appeared.","source_url":"https://europepmc.org/article/MED/14504005","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-044","text":"In a 79-woman in-clinic crossover of topical alprostadil in postmenopausal FSAD, genital vasocongestion beat placebo at every dose and time point (p<0.0001), but patient-rated physical and emotional arousal and satisfaction beat placebo only at the 400 mcg dose; the most common adverse event was mild transient genital burning, typically under one minute.","source_url":"https://europepmc.org/article/MED/16752874","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-045","text":"The largest positive FSAD-cream RCT is Chinese alprostadil (Femprox program): in 400 women, arousal success rates were 33.1% on placebo versus 46.3%, 43.5% and 53.9% on 500, 700 and 900 mcg (900 mcg P=0.0002), with topical irritation the main adverse event and no ECG or laboratory findings.","source_url":"https://europepmc.org/article/MED/18564348","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-046","text":"A pharmacotherapy review of topical alprostadil for FSAD concluded the in-clinic genital effects were not consistently superior to placebo, that three of four at-home trials showed improvements, and that results overall were inconsistent and not reproducible in all trials.","source_url":"https://europepmc.org/article/MED/16757679","grade":"review","grade_label":"Review or guideline"},{"id":"SCR-047","text":"Alprostadil, the only drug with a real multi-trial topical record for female arousal, appears in none of the scream cream formulas this site verified: the documented recipes are built from drugs with thinner or absent female-arousal evidence. Computed from the ingredient lists in the documented-formula table (0 of 3 formulas include alprostadil).","source_url":"https://www.kare-rx.com/products/scream-cream","grade":"derived","grade_label":"Derived from cited data"},{"id":"SCR-048","text":"In anesthetized rats, intravaginal alprostadil cream excited 70% of recorded neurons in the paraventricular nucleus and increased central oxytocin expression, a proposed central mechanism; this is a rat finding and says nothing about efficacy in women.","source_url":"https://europepmc.org/article/MED/19017254","grade":"animal","grade_label":"Animal"},{"id":"SCR-049","text":"The botanical arousal oil Zestra beat placebo in a 20-woman crossover RCT on arousal, desire, satisfaction with arousal, genital sensation, orgasm ability and pleasure, in women with and without FSAD; 3 of 20 reported mild genital burning lasting 5 to 30 minutes.","source_url":"https://europepmc.org/article/MED/12735087","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-050","text":"In a 256-woman, 16-week RCT in mixed female sexual disorders, Zestra provided significant desire, arousal and treatment-satisfaction benefits; the only significant safety finding was mild-to-moderate genital burning in 14.6% of Zestra users and no placebo users.","source_url":"https://europepmc.org/article/MED/20063238","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-051","text":"Zestra is a botanical oil (borage seed and evening primrose oils with extracts), so its two positive RCTs transfer nothing to scream cream: the products share no ingredient. Derived by comparing the Zestra trial descriptions with the documented scream cream formulas.","source_url":"https://europepmc.org/article/MED/20063238","grade":"derived","grade_label":"Derived from cited data"},{"id":"SCR-052","text":"Oral phentolamine 40 mg showed a mild positive effect in a 6-woman single-blind pilot in postmenopausal FSAD, with significant changes only in self-reported lubrication and pleasurable vaginal sensations (p<.05).","source_url":"https://europepmc.org/article/MED/10327383","grade":"human-trial","grade_label":"Human trial"},{"id":"SCR-053","text":"In 41 postmenopausal women with FSAD, vaginal phentolamine 40 mg beat placebo on measured vaginal blood flow only in women on hormone replacement therapy (p=0.0186); subjective benefit likewise appeared only in HRT users, and nothing was significant in women not on HRT.","source_url":"https://europepmc.org/article/MED/11898704","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-054","text":"The human record for topical aminophylline is thigh-fat trials, not arousal: in a 1995 series of small placebo-controlled thigh studies, aminophylline ointment or cream (0.5% to 10%) produced statistically significant girth loss from the treated thigh, serum theophylline remained undetectable, and patch testing was negative.","source_url":"https://europepmc.org/article/MED/8697059","grade":"human-trial","grade_label":"Human trial"},{"id":"SCR-055","text":"An independent randomized trial of twice-daily aminophylline cream for thigh cellulite found no measurable difference versus placebo (p>0.4), with only 3 of 35 treated legs subjectively improved; the authors concluded the treatment was not effective.","source_url":"https://europepmc.org/article/MED/10654755","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-056","text":"A 1996 pharmacotherapy commentary on aminophylline thigh cream concluded the supporting data were limited by small populations and incomplete methods disclosure, quoting the Washington Post's verdict that a proven product remained a 'dream cream'; thirty years later the phrase fits its arousal-cream descendant.","source_url":"https://europepmc.org/article/MED/8833567","grade":"review","grade_label":"Review or guideline"},{"id":"SCR-057","text":"The only genital-cream trial involving an ergoloid (co-dergocrine) tested a testosterone 0.8% + isosorbide dinitrate 0.5% + co-dergocrine 0.06% cream in 42 aged men with erectile dysfunction, where the combination outperformed testosterone cream alone; no trial has tested ergoloid mesylates on female arousal.","source_url":"https://europepmc.org/article/MED/11426345","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-058","text":"FDA approved bremelanotide (Vyleesi, NDA 210557) on June 21, 2019 for acquired, generalized hypoactive sexual desire disorder in premenopausal women; the label states it is not indicated for HSDD in postmenopausal women or in men.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SCR-059","text":"In the two bremelanotide phase 3 trials, desire scores rose a placebo-adjusted +0.30 and +0.42 (integrated +0.35) on a 1.2-to-6.0 scale and distress fell 0.33 integrated; the label reports no significant change in satisfying sexual events (0.0 versus -0.1, p=0.76; 0.0 versus 0.0, p=0.70).","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC6819021/","grade":"human-rct","grade_label":"Human RCT"},{"id":"SCR-060","text":"Nausea was reported by 40% of bremelanotide-treated patients in the phase 3 trials, and the most common adverse reactions in the label include nausea, flushing, injection site reactions and headache.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf","grade":"fda-label","grade_label":"FDA label"},{"id":"SCR-061","text":"Addyi (flibanserin, NDA 022526) was approved August 18, 2015 for acquired, generalized HSDD in premenopausal women, taken nightly, and carries a boxed warning for hypotension and syncope with alcohol close in time, with moderate or strong CYP3A4 inhibitors, and in hepatic impairment.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394","grade":"fda-label","grade_label":"FDA label"},{"id":"SCR-062","text":"A JAMA Internal Medicine meta-analysis of eight flibanserin trials (5,914 women) found one-half additional satisfying sexual event per month (+0.49, 95% CI 0.32 to 0.67) and FSFI desire +0.27, with dizziness RR 4.00, somnolence RR 3.97, nausea RR 2.35, fatigue RR 1.64, discontinuation for adverse events RR 2.19, and overall evidence quality graded very low.","source_url":"https://europepmc.org/article/MED/26927498","grade":"review","grade_label":"Review or guideline"},{"id":"SCR-063","text":"Both approved drugs treat hypoactive sexual desire disorder, not arousal disorder: scream cream is marketed for arousal, a diagnosis for which no drug is approved. If a clinician determines the underlying issue is low desire, two approved options with published trade-offs exist; if it is arousal, nothing approved exists and the compounded cream rests on the per-ingredient record on this page.","source_url":"https://europepmc.org/article/MED/39079074","grade":"derived","grade_label":"Derived from cited data"},{"id":"SCR-064","text":"Whether meaningful sildenafil reaches the bloodstream from a compounded vulvar cream has never been quantified in a published study, so the oral form's nitrate contraindication cannot be ruled in or out for the cream; the only prudent reading is to treat sildenafil-containing creams as carrying the class caution until absorption data exist.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22VIAGRA%22&limit=1","grade":"derived","grade_label":"Derived from cited data"},{"id":"SCR-065","text":"Every placebo-controlled trial of a genital arousal cream or oil that reported tolerability found local reactions as the signature adverse event: application-site discomfort (topical sildenafil), transient genital burning (topical alprostadil, typically under one minute), and genital burning in 14.6% (Zestra); a compounded blend's local tolerability is untested by definition.","source_url":"https://europepmc.org/article/MED/16752874","grade":"derived","grade_label":"Derived from cited data"},{"id":"SCR-066","text":"No pregnancy, lactation or fertility data exist for any scream cream blend: the blend itself has no published studies of any kind, and none of the closest-cousin cream trials enrolled pregnant or breastfeeding women.","source_url":"https://pubmed.ncbi.nlm.nih.gov/?term=%22scream+cream%22","grade":"derived","grade_label":"Derived from cited data"},{"id":"SCR-067","text":"Site census (recomputable from this pack's arrays): 24 study rows (23 human, 1 rat), spanning 9 distinct compound-or-product exposures, none of which is a scream cream blend as sold; 53 citations, of which 29 are peer-reviewed and 22 government, registry or database records, with 2 pharmacy marketing pages used only as market documentation.","source_url":"https://pubmed.ncbi.nlm.nih.gov/?term=%22scream+cream%22","grade":"derived","grade_label":"Derived from cited data"},{"id":"SCR-068","text":"Compounded prescriptions are legal through licensed pharmacies under section 503A, which is why scream cream can be sold without FDA review: a prescriber writes for an individual patient and a pharmacy compounds it, but legality of the pathway is not evidence of efficacy, and FDA does not review these formulas.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers","grade":"regulatory","grade_label":"Regulatory record"}]}