Farxiga Hair and Skin Changes: What Dapagliflozin Does to Your Body

Does Farxiga cause hair loss?

Hair loss is not listed in the label's adverse-reaction table for the glycemic trials [1]. That table includes only reactions that occurred in at least 2% of patients treated with either dose and were more common than on placebo, so it cannot show whether a less frequent reaction occurred [1].

The trials behind the table ran 12 to 24 weeks, with a mean exposure of 21 weeks: 1,393 adults on placebo, 1,145 on dapagliflozin 5 mg and 1,193 on 10 mg [1].

Diffuse shedding after a trigger such as illness, a nutritional deficit or a hormonal shift usually shows up 3 to 4 months later. A review of telogen effluvium notes that increased shedding does not by itself identify a cause; that takes a history and laboratory tests to exclude endocrine, nutritional and autoimmune disorders [2].

What skin problems does dapagliflozin actually cause?

Dapagliflozin blocks SGLT2 in the kidney so that more glucose leaves the body in urine, and that glucosuria persists for about 3 days after the drug is stopped [1]. The label states that Farxiga increases urinary glucose excretion and raises the risk of genitourinary infections, including urinary tract infections and genital yeast infections, in both male and female patients [1]. The adverse reactions seen in 5% or more of patients were female genital mycotic infections, nasopharyngitis and urinary tract infections [1].

Genital yeast infections: how common they are

The clearest numbers come from the 12 pooled placebo-controlled trials in adults with type 2 diabetes [1]:

• Female genital yeast infections: 1.5% on placebo, 8.4% on dapagliflozin 5 mg, 6.9% on 10 mg (598 women on 10 mg) [1]
• Male genital yeast infections: 0.3% on placebo, 2.8% on 5 mg, 2.7% on 10 mg (595 men on 10 mg) [1]
• Urinary tract infections (not a skin condition): 3.7% on placebo, 5.7% on 5 mg, 4.3% on 10 mg [1]
• Discomfort with urination: 0.7% on placebo, 1.6% on 5 mg, 2.1% on 10 mg [1]

The label groups several reported diagnoses under genital yeast infections, including vulvovaginal candidiasis and balanitis [1].

A separate pooled analysis of 12 phase 2b and 3 trials covering 4,545 patients found diagnosed genital infections in 4.1% of those on 2.5 mg, 5.7% on 5 mg and 4.8% on 10 mg, compared with 0.9% on placebo. Most were mild or moderate and responded to standard antimicrobial treatment, discontinuation because of them was rare, and there was no clear dose-response relationship [3]. A 24-week monotherapy trial with a main cohort of 485 adults also reported urinary and genital infection events more often in the dapagliflozin arms than with placebo [4].

The label's most serious genital warning

Farxiga carries no boxed warning [1]. The most serious skin-and-soft-tissue item sits in the Warnings and Precautions section: necrotizing fasciitis of the perineum, or Fournier gangrene [1]. The label calls it a rare, life-threatening infection that requires urgent surgical intervention, notes that cases have needed hospitalization, and lists multiple surgeries and death among the serious outcomes [1].

The label tells prescribers to immediately evaluate a patient with pain or tenderness, erythema or swelling in the genital or perineal area along with fever or malaise for necrotizing fasciitis, and if it is suspected, to discontinue Farxiga and promptly start medical and/or surgical treatment [1]. The same section notes that people with a history of genitourinary infections are more likely to develop them while taking Farxiga [1].

Rash, hives and allergic reactions

The label contraindicates Farxiga in anyone with a history of a serious hypersensitivity reaction to dapagliflozin or any excipient, and states that anaphylaxis and angioedema have been reported with the drug [1].

For ordinary rash, the label's pooled table is a blunt instrument: it lists only reactions that occurred in at least 2% of patients and were more common than on placebo, so a less frequent skin eruption would not necessarily appear in it. Rash is not among the entries in that table [1].

The label's Warnings and Precautions section covers ketoacidosis, volume depletion, genitourinary infections, and hypoglycemia when combined with insulin or insulin secretagogues [1].

Do the heart failure and kidney trials change the picture?

Farxiga is also approved for heart failure and chronic kidney disease. The label states that the overall safety profile was consistent across the studied indications, with no new adverse reactions identified in DAPA-HF, DELIVER or DAPA-CKD [1]. Those trials enrolled 4,744 people with an ejection fraction of 40% or less [5], 6,263 with an ejection fraction above 40% [6], and 4,304 with chronic kidney disease [7].

Drug interactions

The label's interaction table covers four things: insulin and insulin secretagogues (higher hypoglycemia risk), lithium (lower serum lithium concentrations), urine glucose tests (which will be positive) and the 1,5-anhydroglucitol assay (unreliable) [1]. In vitro, dapagliflozin and its main glucuronide metabolite neither inhibited CYP 1A2, 2C9, 2C19, 2D6 or 3A4 nor induced CYP 1A2, 2B6 or 3A4 [1]. The label's interaction studies did not lead to any recommended dapagliflozin dose adjustment [1].