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Dapagliflozin Uses, Dosage, Side Effects & Benefits | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Antidiabetic

Subclass

SGLT2 inhibitor (Sodium-glucose co-transporter 2 inhibitor

Speciality

Endocrinology

Schedule (India)

Schedule H

Routes

Oral

Formulations

5 mg tablets

10 mg tablets

Fixed-dose combinations (FDCs): Dapagliflozin + Metformin (5/500 mg, 5/1000 mg, 10/500 mg, 10/1000 mg); Dapagliflozin + Saxagliptin (5/5 mg, 10/5 mg)

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Type 2 Diabetes Mellitus (T2DM)

Parameter	Recommendation
Starting dose	5 mg once daily in the morning
Titration	Increase to 10 mg once daily after 4–8 weeks if glycaemic control inadequate and drug tolerated
Usual maintenance dose	5–10 mg once daily
Maximum dose	10 mg once daily

Key Clinical Notes:

Adjunct to diet and exercise; monotherapy or add-on to other antidiabetics
Glycaemic efficacy diminishes when eGFR <45 ml/min/1.73m²; avoid initiation for glycaemic control below this threshold
May be continued for cardio-renal benefit even if eGFR falls during treatment

2. Heart Failure with Reduced Ejection Fraction (HFrEF) — NYHA Class II–IV

Parameter	Recommendation
Starting dose	10 mg once daily
Titration	Not applicable
Usual maintenance dose	10 mg once daily
Maximum dose	10 mg once daily

Key Clinical Notes:

Effective irrespective of diabetes status
Use alongside guideline-directed medical therapy (ACEi/ARNi, beta-blocker, MRA)
Continue unless contraindication develops or patient becomes unstable

3. Chronic Kidney Disease (CKD) — Albuminuric, Stages 2–4

Parameter	Recommendation
Starting dose	10 mg once daily
Titration	Not applicable
Usual maintenance dose	10 mg once daily
Maximum dose	10 mg once daily

Key Clinical Notes:

Initiate only if eGFR ≥25 ml/min/1.73m²
May be continued if eGFR falls below 25 during treatment until dialysis or transplant
Provides cardiovascular protection and delays CKD progression independent of diabetic status

Secondary Indications — Adults (Off-label, if any)

Indication	Dose	Duration	Notes
Type 1 Diabetes Mellitus	5 mg once daily (max 10 mg/day)	Individualised	OFF-LABEL; Specialist only. Evidence: Limited RCTs. Not recommended per ICMR 2022 due to elevated DKA risk. Use discouraged in Indian guidelines.

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Type 2 Diabetes Mellitus in Paediatric Population:

Parameter	Recommendation
Approval status	NOT APPROVED in India for patients <18 years
Minimum age	Not recommended under 18 years
Evidence	Safety and efficacy not established in Indian population

Key Clinical Notes:

Use only under paediatric endocrinologist supervision in exceptional cases where no alternatives exist
Not endorsed by ICMR or IAP guidelines for routine paediatric use

Secondary Indications — Paediatrics (Off-label, if any)

Not applicable.

Dapagliflozin is not routinely used in paediatric nephrology or cardiology in India. No established off-label paediatric indications exist.

Renal Adjustments

eGFR (ml/min/1.73m²)	Glycaemic Indication	HFrEF/CKD Indication
≥60	No adjustment	No adjustment
45–59	Start 5 mg; monitor efficacy closely	10 mg once daily
25–44	Avoid initiation for glycaemic control	10 mg once daily (may continue if already on therapy)
<25	Not recommended	Not recommended for initiation; may continue if already stable on therapy
Haemodialysis	Avoid	Avoid
Peritoneal dialysis	Avoid	Avoid

Hepatic adjustment

Contraindications

Hypersensitivity to dapagliflozin or any excipient

Type 1 diabetes mellitus (labelled contraindication due to DKA risk)

History of diabetic ketoacidosis

eGFR <25 ml/min/1.73m² for new initiation (glycaemic, HFrEF, or CKD indications)

Severe volume depletion or actively decompensated states

End-stage renal disease on dialysis

Cautions

Volume depletion or hypotension risk (elderly, patients on loop diuretics, low BP at baseline)

History of recurrent genital mycotic infections or urinary tract infections

Moderate hepatic impairment

Concurrent use of insulin or sulfonylureas (increased hypoglycaemia risk — dose reduction of insulin/SU may be necessary)

Active lower limb ulcers or peripheral vascular disease (monitor closely)

Patients undergoing major surgery or fasting (hold drug 2–3 days prior to reduce DKA risk)

Acute febrile illness, vomiting, diarrhoea, or reduced oral intake — temporary discontinuation advised

Risk of euglycaemic DKA — high index of suspicion required even with normal blood glucose

Pregnancy

Parameter	Recommendation
Risk category	Not recommended; limited human data
Trimester-specific concern	Avoid in 2nd and 3rd trimester — potential for fetal renal developmental toxicity (animal data)
Preferred alternatives	Insulin (all trimesters) as per ICMR and Indian obstetric guidelines
When it may be used	Only under specialist input when insulin is not feasible and benefits clearly outweigh risks
Monitoring	Fetal growth by ultrasound; amniotic fluid volume; maternal renal function

Lactation

Parameter	Recommendation
Compatibility	Not compatible with breastfeeding
Milk excretion	Expected (based on animal studies); human data unavailable
Preferred alternatives	Insulin or metformin (both considered safe in lactation)
Infant monitoring	If accidental exposure — monitor feeding, hydration status, urine output

Elderly

Parameter	Recommendation
Starting dose	5 mg once daily
Titration	Slower; assess tolerance over 4–8 weeks before increasing
Special risks	Orthostatic hypotension, falls, dehydration, acute kidney injury, urinary tract infections
Monitoring	Renal function (eGFR) and volume status at baseline and regularly; blood pressure monitoring

Major drug interactions

Interacting Drug	Effect	Management
Loop diuretics (furosemide, torsemide)	Additive volume depletion; increased risk of hypotension and AKI	Assess volume status; consider reducing diuretic dose at initiation
Insulin	Increased hypoglycaemia risk	Reduce insulin dose by 10–20% at initiation; close glucose monitoring
Sulfonylureas (glimepiride, gliclazide)	Increased hypoglycaemia risk	Consider reducing SU dose; educate patient on hypoglycaemia symptoms
Other SGLT2 inhibitors	No additive benefit; increased adverse effects	Avoid duplication
Lithium	Altered renal clearance of lithium	Monitor serum lithium levels closely

Moderate drug interactions

Interacting Drug	Effect	Management
NSAIDs (ibuprofen, diclofenac)	Increased risk of AKI	Monitor renal function; avoid prolonged concurrent use
ACE inhibitors / ARBs	Cumulative hypotensive effect; risk of AKI at initiation	Monitor BP and creatinine after starting; ensure adequate hydration
Rifampicin	Induces UGT1A9; may reduce dapagliflozin exposure	Monitor HbA1c; may need alternative antidiabetic in TB patients
Thiazide diuretics	Additive diuresis and electrolyte disturbance	Monitor electrolytes and hydration status
Digoxin	May slightly increase digoxin levels	Clinical significance low; routine monitoring sufficient

Common Adverse effects

Genital fungal infections (vulvovaginal candidiasis, balanitis) — more frequent in females
Urinary tract infection
Increased urinary frequency / polyuria
Thirst
Mild weight loss (1–3 kg typically)
Nasopharyngitis
Back pain
Hypoglycaemia (when combined with insulin or sulfonylureas)
Dizziness or postural hypotension (especially in volume-depleted patients)

Serious Adverse effects

Adverse Effect	Notes
Diabetic ketoacidosis (DKA)	May occur with near-normal or mildly elevated glucose (euglycaemic DKA); requires immediate discontinuation and hospitalisation
Fournier's gangrene	Necrotising fasciitis of the perineum; rare but life-threatening; urgent surgical referral
Acute kidney injury	Higher risk in elderly, volume-depleted, or those on nephrotoxic agents; discontinue if AKI develops
Severe hypoglycaemia	When used with insulin or sulfonylureas
Lower limb amputation	Reported in class; monitor foot health in diabetics
Bone fractures	Rare; consider in patients with osteoporosis risk
Severe UTI / Urosepsis	Discontinue and treat promptly

Monitoring requirements

Timing	Parameters
Baseline	eGFR, serum creatinine, blood pressure, volume status, HbA1c (if T2DM), urogenital infection history, LFTs (if hepatic concern)
After initiation / dose change (2–4 weeks)	Blood pressure, hydration status, serum creatinine/eGFR, symptoms of hypotension or UTI
Every 3–6 months	HbA1c (for glycaemic indication), renal function
Long-term / Annual	eGFR, urine albumin-creatinine ratio (for CKD), periodic foot examination, genital hygiene review
Sick day / Acute illness	Urine or blood ketones if patient unwell; temporary discontinuation if vomiting, fasting, or dehydrated

Brands in India

Brand Name	Manufacturer	Notes
Forxiga	AstraZeneca	Innovator brand
Dapaglyn	Sun Pharma
Oxra	Intas
Dapaworth	Lupin
Dapasure	Mankind
Dapact	Zydus
Kombiglyze XR	AstraZeneca	FDC with saxagliptin
Xigduo	AstraZeneca	FDC with metformin
Various generics	Multiple	Dapazide, Dapacose, etc.

Price range (INR)

Formulation	Approximate Price
Dapagliflozin 10 mg (per tablet)	₹12–30 (generics); ₹35–50 (branded)
Dapagliflozin 5 mg (per tablet)	₹10–25
FDC with metformin (per tablet)	₹12–25
FDC with saxagliptin (per tablet)	₹20–35

NPPA status: 10 mg tablet included in NLEM 2022; price ceiling applicable.

Clinical pearls

First-line add-on in high-risk T2DM: Prefer dapagliflozin in patients with established ASCVD, HFrEF, or CKD with albuminuria — irrespective of HbA1c at baseline.
Glycaemic benefit diminishes at low eGFR: Do not initiate for glucose lowering if eGFR <45 ml/min/1.73m², but cardio-renal benefits persist at lower eGFR.
Euglycaemic DKA awareness: Counsel patients on symptoms (nausea, abdominal pain, fatigue, dyspnoea) even with normal glucose. High index of suspicion in fasting, perioperative, or low-carb diet settings.
Sick day rules: Advise temporary discontinuation during acute illness, dehydration, fasting, or major surgery (hold 2–3 days prior).
Genital hygiene counselling: Reduces risk of candidiasis; especially important in females and uncircumcised males.
Volume status first: Always assess hydration before initiation; consider reducing concurrent diuretics if hypotension risk is high.

Version

RxIndia v1.1 — 09 Jul 2025

Reference

CDSCO approved prescribing information
Indian National List of Essential Medicines (NLEM 2022)
API Textbook of Medicine (11th Edition)
ICMR Guidelines for Management of Type 2 Diabetes (2022)
AIIMS Formulary
Cardiological Society of India — Heart Failure Guidelines (aligned sections)
DAPA-HF, DAPA-CKD, DECLARE-TIMI 58 trials (evidence support for approved indications as aligned with Indian regulatory approvals)
KDIGO 2022 (cited only where aligned with Indian nephrology protocols)

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Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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Parameter

Recommendation

Starting dose

5 mg once daily in the morning

Titration

Increase to 10 mg once daily after 4–8 weeks if glycaemic control inadequate and drug tolerated

Usual maintenance dose

5–10 mg once daily

Maximum dose

10 mg once daily

Parameter

Recommendation

Starting dose

10 mg once daily

Titration

Not applicable

Usual maintenance dose

10 mg once daily

Maximum dose

10 mg once daily

Parameter

Recommendation

Starting dose

10 mg once daily

Titration

Not applicable

Usual maintenance dose

10 mg once daily

Maximum dose

10 mg once daily

Indication

Dose

Duration

Notes

Type 1 Diabetes Mellitus

5 mg once daily (max 10 mg/day)

Individualised

OFF-LABEL; Specialist only. Evidence: Limited RCTs. Not recommended per ICMR 2022 due to elevated DKA risk. Use discouraged in Indian guidelines.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Type 2 Diabetes Mellitus in Paediatric Population:

Parameter	Recommendation
Approval status	NOT APPROVED in India for patients <18 years
Minimum age	Not recommended under 18 years
Evidence	Safety and efficacy not established in Indian population

eGFR (ml/min/1.73m²)

Glycaemic Indication

HFrEF/CKD Indication

≥60

No adjustment

45–59

Start 5 mg; monitor efficacy closely

10 mg once daily

25–44

Avoid initiation for glycaemic control

10 mg once daily (may continue if already on therapy)

<25

Not recommended

Not recommended for initiation; may continue if already stable on therapy

Haemodialysis

Avoid

Peritoneal dialysis

Avoid

Parameter

Recommendation

Risk category

Not recommended; limited human data

Trimester-specific concern

Avoid in 2nd and 3rd trimester — potential for fetal renal developmental toxicity (animal data)

Preferred alternatives

Insulin (all trimesters) as per ICMR and Indian obstetric guidelines

When it may be used

Only under specialist input when insulin is not feasible and benefits clearly outweigh risks

Monitoring

Fetal growth by ultrasound; amniotic fluid volume; maternal renal function

Parameter

Recommendation

Compatibility

Not compatible with breastfeeding

Milk excretion

Expected (based on animal studies); human data unavailable

Preferred alternatives

Insulin or metformin (both considered safe in lactation)

Infant monitoring

If accidental exposure — monitor feeding, hydration status, urine output

Parameter

Recommendation

Starting dose

5 mg once daily

Titration

Slower; assess tolerance over 4–8 weeks before increasing

Special risks

Orthostatic hypotension, falls, dehydration, acute kidney injury, urinary tract infections

Monitoring

Renal function (eGFR) and volume status at baseline and regularly; blood pressure monitoring

Interacting Drug

Effect

Management

Loop diuretics (furosemide, torsemide)

Additive volume depletion; increased risk of hypotension and AKI

Assess volume status; consider reducing diuretic dose at initiation

Insulin

Increased hypoglycaemia risk

Reduce insulin dose by 10–20% at initiation; close glucose monitoring

Sulfonylureas (glimepiride, gliclazide)

Increased hypoglycaemia risk

Consider reducing SU dose; educate patient on hypoglycaemia symptoms

Other SGLT2 inhibitors

No additive benefit; increased adverse effects

Avoid duplication

Lithium

Altered renal clearance of lithium

Monitor serum lithium levels closely

Interacting Drug

Effect

Management

NSAIDs (ibuprofen, diclofenac)

Increased risk of AKI

Monitor renal function; avoid prolonged concurrent use

ACE inhibitors / ARBs

Cumulative hypotensive effect; risk of AKI at initiation

Monitor BP and creatinine after starting; ensure adequate hydration

Rifampicin

Induces UGT1A9; may reduce dapagliflozin exposure

Monitor HbA1c; may need alternative antidiabetic in TB patients

Thiazide diuretics

Additive diuresis and electrolyte disturbance

Monitor electrolytes and hydration status

Digoxin

May slightly increase digoxin levels

Clinical significance low; routine monitoring sufficient

Adverse Effect

Notes

Diabetic ketoacidosis (DKA)

May occur with near-normal or mildly elevated glucose (euglycaemic DKA); requires immediate discontinuation and hospitalisation

Fournier's gangrene

Necrotising fasciitis of the perineum; rare but life-threatening; urgent surgical referral

Acute kidney injury

Higher risk in elderly, volume-depleted, or those on nephrotoxic agents; discontinue if AKI develops

Severe hypoglycaemia

When used with insulin or sulfonylureas

Lower limb amputation

Reported in class; monitor foot health in diabetics

Bone fractures

Rare; consider in patients with osteoporosis risk

Severe UTI / Urosepsis

Discontinue and treat promptly

Timing

Parameters

Baseline

eGFR, serum creatinine, blood pressure, volume status, HbA1c (if T2DM), urogenital infection history, LFTs (if hepatic concern)

After initiation / dose change (2–4 weeks)

Blood pressure, hydration status, serum creatinine/eGFR, symptoms of hypotension or UTI

Every 3–6 months

HbA1c (for glycaemic indication), renal function

Long-term / Annual

eGFR, urine albumin-creatinine ratio (for CKD), periodic foot examination, genital hygiene review

Sick day / Acute illness

Urine or blood ketones if patient unwell; temporary discontinuation if vomiting, fasting, or dehydrated

Brand Name

Manufacturer

Notes

Forxiga

AstraZeneca

Innovator brand

Dapaglyn

Sun Pharma

Oxra

Intas

Dapaworth

Lupin

Dapasure

Mankind

Dapact

Zydus

Kombiglyze XR

AstraZeneca

FDC with saxagliptin

Xigduo

AstraZeneca

FDC with metformin

Various generics

Multiple

Dapazide, Dapacose, etc.

Formulation

Approximate Price

Dapagliflozin 10 mg (per tablet)

₹12–30 (generics); ₹35–50 (branded)

Dapagliflozin 5 mg (per tablet)

₹10–25

FDC with metformin (per tablet)

₹12–25

FDC with saxagliptin (per tablet)

₹20–35