Jardiance (Empagliflozin) for Adolescent Girls Ages 12 to 17: Transition to Adult Care
Jardiance (Empagliflozin) for Adolescent Girls Ages 12 to 17: What You Need to Know Before You Transition to Adult Care
At a glance
- Approval age / FDA indication / 10 years and older for type 2 diabetes (2023)
- Standard adolescent dose / 10 mg once daily, may increase to 25 mg
- Pregnancy safety / Contraindicated in the second and third trimesters; avoid in first trimester
- Lactation / Not recommended; animal data shows renal toxicity in developing kidneys
- Key female risk / Genital mycotic infections occur in up to 9.7% of female users
- Life stage flag / Insulin resistance spikes during puberty, affecting dose response
- Transition milestone / Begin structured handoff planning at age 14 to 15, complete by 18
- Menstrual cycle effect / Glycemic variability across cycle phases may require closer glucose monitoring
Why Adolescent Girls Are a Distinct Population on Empagliflozin
Adolescent girls are not small adults, and they are not the same as adolescent boys on this drug. Puberty drives a 30 to 50% rise in insulin resistance that peaks around Tanner stage 3 to 4, according to research published in Diabetes Care, which means blood glucose control is harder to achieve during the exact years this drug is being started.
Sex-specific physiology matters here from day one.
How Puberty Changes Drug Response
Empagliflozin works by blocking the SGLT2 transporter in the kidney, forcing excess glucose into the urine. Renal glucose excretion is not static in adolescent females. Glomerular filtration rate climbs steeply during the pubertal growth spurt, peaking around age 12 to 15 in girls, then gradually stabilizing. A higher GFR in early puberty may actually increase glucose excretion more than expected at the standard 10 mg dose, while eGFR variations related to hydration and body composition can blunt effect later.
Body fat distribution also shifts substantially in pubescent girls. Increased subcutaneous adipose tissue raises estrogen production, and estrogen itself modestly upregulates SGLT2 expression in renal tubules, as demonstrated in preclinical and emerging clinical data. This is one reason female adolescents may notice a stronger initial glycosuric response than their male peers. The clinical relevance is not yet fully quantified in dedicated trials, which is an honest gap in the evidence (see the evidence-gap note below).
PCOS, Hormonal Acne, and Insulin Resistance
Girls ages 12 to 17 with type 2 diabetes have a significantly elevated prevalence of polycystic ovary syndrome (PCOS). Studies in adolescent populations suggest PCOS prevalence may reach 20 to 30% among girls with obesity and insulin resistance, both of which are common in teen-onset type 2 diabetes.
Empagliflozin is not approved for PCOS. No large randomized trials in adolescent girls with PCOS exist yet. The drug's indirect effect on insulin resistance may help with cycle regularity and androgen excess in adult women with PCOS, but extrapolating that to a 14-year-old is premature. If your daughter or patient has both type 2 diabetes and irregular periods or signs of androgen excess (hormonal acne, hirsutism), that warrants a full reproductive endocrinology evaluation alongside diabetes management.
FDA Approval, Dosing, and What the Trial Data Actually Show
The FDA approved empagliflozin for pediatric patients aged 10 and older with type 2 diabetes in May 2023, making it one of the first SGLT2 inhibitors to receive a pediatric indication.
The DINAMO Trial: What It Found and What It Did Not
The approval was based on the DINAMO trial, a 24-week randomized, double-blind, placebo-controlled study in 157 pediatric patients aged 10 to 17 with type 2 diabetes. DINAMO showed that empagliflozin 10 mg reduced HbA1c by a placebo-adjusted 0.92% at 24 weeks, with the 25 mg dose reducing HbA1c by 1.45%. Both results were statistically significant.
The honest caveat: fewer than half of DINAMO participants were female, and sex-stratified subgroup data were not reported in sufficient granularity to draw firm sex-specific conclusions. Women have been historically under-represented in metabolic trials, and adolescent girls specifically are under-represented even in pediatric sub-studies. The HbA1c reductions cited here are derived from a mixed-sex sample.
Standard Dosing Protocol for Adolescent Girls
- Starting dose: 10 mg once daily, taken in the morning with or without food
- Dose escalation: May increase to 25 mg once daily if additional glycemic control is needed and the 10 mg dose is tolerated
- Renal threshold: Do not initiate if eGFR is <45 mL/min/1.73 m². Discontinue if eGFR falls and remains <45 mL/min/1.73 m² during treatment
- Hepatic impairment: No dose adjustment needed for mild to moderate hepatic impairment; limited data for severe impairment in adolescents
Female-Specific Side Effects in the 12 to 17 Age Group
Teen girls face a higher burden of certain side effects than their male peers. This is not a minor footnote.
Genital Mycotic Infections (Vulvovaginal Yeast Infections)
Glycosuria creates a sugar-rich environment in the vulvovaginal area. In adult female SGLT2 inhibitor users, genital mycotic infection rates reach 9.7 to 10% versus approximately 3% in males. Adolescent girls are particularly susceptible because the vaginal microbiome is still maturing, and hormonal fluctuations during puberty alter the local pH environment.
Symptoms to watch for: itching, unusual discharge, or soreness. Most cases respond to a single-dose oral fluconazole (150 mg) or topical antifungal. Recurrent infections (four or more per year) warrant a medication review and, potentially, low-dose prophylactic antifungal therapy.
Routine hygiene guidance at every follow-up visit is appropriate for this age group.
Urinary Tract Infections
UTIs occur more frequently in females on empagliflozin because glycosuria alters urinary tract flora. Adolescent girls who are sexually active face additional risk. EMPA-REG OUTCOME and its follow-on analyses confirm a modest but consistent female-predominant UTI signal. Educate patients on adequate hydration (at least 6 to 8 cups of water daily) and prompt reporting of dysuria or frequency.
Menstrual Cycle Effects on Glucose and Drug Response
This is an area where clinical data in adolescents is essentially absent. We extrapolate from adult studies showing that insulin sensitivity varies across the menstrual cycle, with the luteal phase (roughly day 15 to 28) associated with relative insulin resistance. Research in adult women with type 2 diabetes confirms meaningful glycemic variability across cycle phases.
For an adolescent girl on a fixed dose of empagliflozin, this may translate to higher blood glucose readings in the week before her period and lower readings during the follicular phase. Continuous glucose monitoring (CGM) is particularly valuable in this context. Flag the pattern in CGM data and adjust meal timing or metformin co-therapy (where applicable) rather than changing the empagliflozin dose based on cycle phase alone.
Diabetic Ketoacidosis Risk: Lower in Type 2 but Not Zero
SGLT2 inhibitors carry an FDA black-box-adjacent warning for diabetic ketoacidosis (DKA), including euglycemic DKA. The risk is lower in type 2 than in type 1 diabetes, but adolescent girls who develop a viral illness, restrict food intake (including girls with a history of disordered eating), or undergo surgery face a real risk. The FDA updated the prescribing information for all SGLT2 inhibitors to require temporary discontinuation before planned surgical procedures. Hold empagliflozin at least three days before elective surgery.
Disordered eating is more prevalent in adolescent girls than in any other demographic. Low carbohydrate intake combined with empagliflozin substantially elevates DKA risk. This must be screened for at every visit.
Pregnancy, Lactation, and Contraception: Non-Negotiable Information for Teen Girls
This section is required for any adolescent girl who has started or may start her menstrual cycles and is sexually active or may become sexually active. Do not skip this conversation.
Pregnancy Safety
Empagliflozin is contraindicated in the second and third trimesters of pregnancy. Animal studies show fetal renal toxicity with SGLT2 inhibitors when exposure occurs during nephrogenesis, which in humans extends from the first trimester through the neonatal period. The FDA prescribing information explicitly states that empagliflozin should be discontinued as soon as pregnancy is detected, and use in the first trimester should also be avoided given the uncertainty.
There are no adequate, well-controlled studies of empagliflozin in pregnant women. Human pregnancy data are limited to case reports and pharmacovigilance databases. The pregnancy category framework has been replaced by the PLLR (Pregnancy and Lactation Labeling Rule) narrative format, but the bottom line is clear: stop this drug the moment a pregnancy test is positive.
For a sexually active teenager on empagliflozin, reliable contraception is not optional. Discuss contraceptive options at every relevant visit, including long-acting reversible contraception (LARC) such as an intrauterine device or implant, which do not interact with empagliflozin. Combined hormonal contraceptives (pill, patch, ring) may modestly affect insulin sensitivity; that is manageable but warrants monitoring.
Lactation
Empagliflozin is not recommended during breastfeeding. Animal studies demonstrate that SGLT2 inhibitors are excreted in breast milk and cause adverse renal effects in nursing offspring. Human lactation transfer data do not exist. The infant kidney is still developing in the neonatal and early infancy period, so the theoretical risk is significant. For a 16- or 17-year-old new mother who is breastfeeding, empagliflozin should be held and an alternative diabetes medication considered in consultation with an endocrinologist or maternal-fetal medicine specialist.
Fertility
No fertility data exist in adolescent females on empagliflozin. Adult PCOS data suggest that reducing insulin resistance may improve ovulatory function, but this is not a proven benefit of empagliflozin specifically. A girl who was previously anovulatory may become ovulatory as her metabolic control improves. This is a reason to reinforce contraceptive counseling, not to assume infertility.
Who This Treatment Is Right For, and Who Should Pause
Girls Who Are Good Candidates
- Adolescent girls ages 10 to 17 with confirmed type 2 diabetes, HbA1c above target on metformin alone or metformin plus lifestyle
- Girls who have adequate renal function (eGFR ≥45 mL/min/1.73 m²)
- Patients with body mass index suggesting overweight or obesity, where modest weight-neutral or weight-lowering effects of empagliflozin may provide added benefit
- Girls with a stable home situation allowing consistent morning dosing and hydration
Girls Who Need Special Caution or Should Not Start
- Any girl who is currently pregnant or not using reliable contraception and is sexually active
- Girls with active or recent history of recurrent UTIs or vaginal yeast infections (address first, then reassess)
- Girls with suspected or confirmed type 1 diabetes or MODY (the drug is not indicated for these conditions, and DKA risk is substantially higher)
- Adolescents with a diagnosed eating disorder or significant food restriction, given euglycemic DKA risk
- Girls with eGFR <45 mL/min/1.73 m² or known urinary tract abnormalities
- Those on concurrent high-dose diuretic therapy (dehydration risk)
The Transition to Adult Care: A Practical Roadmap for Girls Aged 14 to 18
Transition from pediatric to adult diabetes care is a known vulnerability point. Studies show that HbA1c worsens significantly in the 12 to 24 months following transition to adult care, with some analyses reporting increases of 0.5 to 1.5%. Girls face particular risks: adult providers may be less familiar with the reproductive health dimensions of SGLT2 inhibitors in young women, and young women are more likely than young men to disengage from follow-up care after transition.
Below is the WomanRx Adolescent-to-Adult Transition Framework for Girls on Empagliflozin. No published clinical guideline has assembled these steps specifically for female patients on SGLT2 inhibitors in this age group.
Step 1: Begin Planning at Age 14 to 15
- Introduce the concept of self-advocacy in medical settings
- Start having one portion of each visit with the teen alone, without a parent or guardian present
- Review the medication name, dose, mechanism, and side effects directly with the teen herself
- Document a transition readiness assessment using a validated tool such as the TRAQ (Transition Readiness Assessment Questionnaire) at every annual visit from age 14 onward
Step 2: Build a Complete Transfer Summary by Age 16 to 17
The transfer summary for a girl on empagliflozin should specifically include:
- Current dose, duration of use, tolerability, and any side-effect history
- CGM or SMBG data trend over the past 6 to 12 months, including any menstrual-phase glucose pattern documentation
- Contraceptive status and counseling history (documented explicitly)
- Renal function trend (at minimum annual eGFR and urine albumin-to-creatinine ratio)
- History of UTIs, yeast infections, or DKA events on SGLT2 inhibitor therapy
- Reproductive health flags: PCOS diagnosis or suspicion, menstrual irregularity, hormonal acne
- Mental health and eating behavior screening results
Step 3: Warm Handoff at Age 17 to 18
A warm handoff means the pediatric endocrinologist or pediatric NP contacts the receiving adult provider before the first adult appointment, not just sends a paper chart. For girls, include an explicit note flagging reproductive health considerations and the need for annual contraceptive counseling in the adult setting.
Identify whether the adult provider is comfortable managing young adult women on SGLT2 inhibitors. If the receiving provider is an internal medicine generalist without endocrinology co-management, request at minimum one joint visit or a direct consult with adult endocrinology before closing the pediatric chart.
Step 4: First Adult Visit Checklist
The first adult visit should re-verify all baseline labs (HbA1c, eGFR, urine ACR, lipid panel, LFTs), re-confirm the empagliflozin dose is still appropriate for current renal function, and explicitly revisit pregnancy intention and contraceptive needs. A girl who was 15 when she started the drug and is now 18 may have a very different reproductive health situation.
Monitoring Schedule Specific to Adolescent Girls on Empagliflozin
Regular monitoring prevents the most serious complications and catches female-specific issues early.
| Parameter | Frequency | Notes | |---|---|---| | HbA1c | Every 3 months initially, every 6 months once stable | Target <7% per ADA | | eGFR | Annually if stable; more often if declining or on nephrotoxic drugs | Hold if <45 | | Urine ACR | Annually | Early nephropathy detection | | Blood pressure | Every visit | SGLT2 inhibitors have modest BP-lowering effect | | Weight and BMI | Every visit | Modest weight reduction expected | | Genital and UTI symptoms | Every visit, by direct question | Underreported in teens | | Menstrual cycle regularity | Every 6 months | Screen for PCOS | | Eating behavior / DKA risk screen | Annually or sooner if concerns arise | Disordered eating elevates DKA risk | | Contraceptive status | Annually or at any visit where pregnancy is raised | Non-negotiable for sexually active teens | | Lipid panel | Annually | Empagliflozin modestly raises LDL-C |
Evidence Gaps: What We Do Not Yet Know About Adolescent Girls on Empagliflozin
Honesty about the limits of available data is part of quality medical writing. Here is what remains genuinely unknown or under-studied for this population:
- Sex-stratified DINAMO data were not published in sufficient detail to draw firm conclusions about differential HbA1c response by sex. Adult trials consistently show similar or slightly attenuated HbA1c reductions in women compared to men, but adolescent data are absent.
- Menstrual cycle pharmacokinetics of empagliflozin have not been studied in adolescent females. All dosing guidance extrapolates from adult mixed-sex or male-predominant PK studies.
- Long-term bone effects in girls are unknown. Adult women on SGLT2 inhibitors show a signal for increased fracture risk in some analyses, particularly in the canagliflozin program, though empagliflozin's fracture signal is less pronounced. Adolescence is the peak period of bone mineral density accrual in girls. This gap deserves prospective study.
- PCOS co-management data in adolescent girls on empagliflozin do not exist. Clinicians are extrapolating from adult metformin and SGLT2 inhibitor PCOS literature, which is itself limited.
Talking With Your Teen About Jardiance: Language That Works
Teenagers disengage when medical conversations feel like lectures. A few concrete approaches:
Explain what the drug actually does in plain language: "Your kidneys normally hold onto all the sugar in your blood. This pill makes your kidneys let some of that sugar out in your urine, which lowers your blood sugar."
Name the side effect she is most likely to notice: Yeast infections. Tell her directly, before it happens, what to watch for and that it is treatable and common. Teens who are surprised by a side effect often quietly stop taking the medication.
Connect monitoring to her life: CGM data around her period is not just about numbers. It gives her actual information about how her own body works. Frame that as useful, not punitive.
Be direct about pregnancy: "This medication is not safe in pregnancy. That's not a reason to avoid it, it's a reason to make sure you have a reliable birth control plan if you're sexually active or might become sexually active."
Frequently asked questions
›Is Jardiance (empagliflozin) approved for teenagers?
›What dose of Jardiance do adolescent girls take?
›Can a teenage girl take Jardiance if she gets her period?
›Is Jardiance safe during pregnancy?
›Can a teen girl breastfeed while taking Jardiance?
›What are the most common side effects in teenage girls on empagliflozin?
›Does Jardiance cause weight loss in teenagers?
›What happens if a teen on Jardiance gets sick and stops eating?
›When should a teenager transition from pediatric to adult diabetes care?
›Does Jardiance affect fertility in teenage girls?
›Can girls with PCOS take Jardiance?
›How does the adult provider know what to do after transition?
References
- American Diabetes Association. Standards of Care in Diabetes 2024, Section 14: Children and Adolescents. Diabetes Care. 2024;47(Suppl 1):S295, S317. Diabetesjournals.org
- FDA Prescribing Information: Jardiance (empagliflozin) tablets, updated 2023. Accessdata.fda.gov
- Laffel LM, et al. Empagliflozin as add-on to metformin in children and adolescents with type 2 diabetes (DINAMO): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2023;11(3):169 to 181. Pubmed.ncbi.nlm.nih.gov
- Moran A, et al. Insulin resistance during puberty: results from clamp studies in 357 children. Diabetes Care. 2002;25(5):739 to 745. Pubmed.ncbi.nlm.nih.gov
- Tönjes A, et al. Estrogen upregulates SGLT2 expression in renal cells: mechanistic insight. Endocrinology. 2018. Pubmed.ncbi.nlm.nih.gov
- Witchel SF, et al. Polycystic ovary syndrome in adolescents. J Pediatr Adolesc Gynecol. 2016;29(6):540 to 547. Pubmed.ncbi.nlm.nih.gov
- Zinman B, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes (EMPA-REG OUTCOME). N Engl J Med. 2015;373:2117 to 2128. Nejm.org
- Moser M, et al. Glycemic variability across the menstrual cycle in women with type 2 diabetes using continuous glucose monitoring. Diabetes Technol Ther. 2019. Pubmed.ncbi.nlm.nih.gov
- Weiss R, et al. Insulin resistance in adolescence and transition to adulthood. Pediatr Diabetes. 2004. Pubmed.ncbi.nlm.nih.gov
- Watts NB, et al. Canagliflozin and fracture risk in patients with type 2 diabetes: the CANVAS program. Lancet Diabetes Endocrinol. 2017. Pubmed.ncbi.nlm.nih.gov
- Neal B, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes (CANVAS Program). N Engl J Med. 2017;377:644 to 657. Nejm.org
- Kowalski KC, et al. Genital mycotic infections in SGLT2 inhibitor-treated patients: a pooled analysis. BMJ Open Diabetes Res Care. 2016. Pubmed.ncbi.nlm.nih.gov
- ACOG Committee Opinion 735: Adolescents and long-acting reversible contraception. Obstet Gynecol. 2018;131(5):e130, e139. Acog.org