Quick answers
- What is Telmisartan, amlodipine and indapamide used for?
- The FDA-approved label (Widaplik, Azurity Pharmaceuticals, Inc., July 3, 2026) says: “Widaplik (telmisartan/amlodipine/indapamide) is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Widaplik may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Telmisartan, amlodipine and indapamide?
- The “Adverse Reactions” section of the FDA label (Widaplik, Azurity Pharmaceuticals, Inc., July 3, 2026) begins: “The following is discussed in more detail in other sections of the labeling: • Fetal toxicity [see Warnings and Precautions (5.1)] • Hypotension [see Warnings and Precautions (5.2)] • Electrolyte and Glucose Imbalances [see Warnings and Precautions (5.3)] • Impaired Renal Function [see Warnings and Precautions (5.4)] • Acute Angle-Closure Glaucoma, Acute Myopia, and Choroidal Effusion [see Warnings and Precautions (5.5)] • Hyperuricemia [see Warnings and Precautions (5.6)] The most common adverse reaction is symptomatic hypotension.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Telmisartan, amlodipine and indapamide?
- The “Drug Interactions” section of the FDA label (Widaplik, Azurity Pharmaceuticals, Inc., July 3, 2026) begins: “NSAIDs: Increased risk of renal impairment and loss of anti-hypertensive effect (7.1) If simvastatin is co-administered with Widaplik, do not exceed doses greater than 20 mg daily of simvastatin (7.2) Do not co-administer aliskiren with Widaplik in patients with diabetes (7.1) 7.1 Drug Interactions with Telmisartan Aliskiren and other renin-angiotensin-aldosterone system (RAAS) inhibitors: Do not co-administer aliskiren with Widaplik in patients with diabetes.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Telmisartan, amlodipine and indapamide have a boxed warning?
- Yes. The FDA label for Widaplik has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Telmisartan, amlodipine and indapamide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Telmisartan, amlodipine and indapamide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Telmisartan, amlodipine and indapamide?
- 1 company lists prescription products of Telmisartan, amlodipine and indapamide in the FDA NDC Directory, including Azurity Pharmaceuticals, Inc.
What Telmisartan, amlodipine and indapamide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Widaplik (telmisartan/amlodipine/indapamide) is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Widaplik may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …
— FDA label: Widaplik, Azurity Pharmaceuticals, Inc., effective July 3, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Widaplik, Azurity Pharmaceuticals, Inc.; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY
. Read it on the full label →
Telmisartan, amlodipine and indapamide boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Widaplik as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
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- When pregnancy is detected, discontinue WIDAPLIK as soon as possible (5.1, 8.1)
- Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus (5.1, 8.1)
— FDA label: Widaplik, Azurity Pharmaceuticals, Inc., effective July 3, 2026. Read the full label on DailyMed →
Telmisartan, amlodipine and indapamide side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following is discussed in more detail in other sections of the labeling:
- Fetal toxicity [see Warnings and Precautions (5.1)]
- Hypotension [see Warnings and Precautions (5.2)]
- Electrolyte and Glucose Imbalances [see Warnings and Precautions (5.3)]
- Impaired Renal Function [see Warnings and Precautions (5.4)]
- Acute Angle-Closure Glaucoma, Acute Myopia, and Choroidal Effusion [see Warnings and Precautions (5.5)]
- Hyperuricemia [see Warnings and Precautions (5.6)] The most common adverse reaction is symptomatic hypotension.
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Low sodium and potassium values were recorded more often with Widaplik compared to placebo (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Widaplik Safety data were obtained from two randomized controlled studies that included 1,680 randomized patients with hypertension of whom 782 received Widaplik. Given the well-established safety profiles of the component medicines, only serious adverse events and the following adverse events of special interest were recorded: symptomatic hypotension, abnormal laboratory findings (sodium, potassium, uric acid, glucose, lipids, creatinine, eGFR), headache, peripheral edema, or other reason for discontinuation of study medication. Study 1 In Study 1 (NCT04518306), 295 adult patients who were not receiving antihypertensive treatment for two weeks with baseline home systolic blood pressure 130-154 mmHg were randomized in a 2:2:1 ratio to Widaplik (10 mg/1.25 mg/0.625 mg), Widaplik (20 mg/2.5 mg/1.25 mg), or placebo. The study was 4 weeks in duration and randomized 232 patients to Widaplik and 63 to placebo. The proportion of patients who discontinued study medication due to an adverse event was 0% for Widaplik (10 mg/1.25 mg/0.625 mg), 5.1% for Widaplik (20 mg/2.5 mg/1.25 mg), and 1.6% for placebo. Symptomatic hypotension, hyponatremia, and hypokalemia were more common with Widaplik than placebo (see Table 1). Most cases were mild to moderate in severity. Table 1: Adverse Reactions Reported in >2% of Patients Treated with Widaplik during the 4-Week Placebo-Controlled Treatment Period of Study 1 Widaplik (10 mg/1.25 mg/0.625 mg) (n=113) Widaplik (20 mg/2.5 mg/1.25 mg) (n=118) Placebo (n=62) Symptomatic hypotension n (%) 4 (3.5%) 6 (5.1%) 0 (0%) Sodium <135 mmol/L at week 4, n (%) 4 (3.5%) 1 (0.8%) 0 (0%) Potassium <3.5 mmol/L at week 4, n (%) 4 (3.5%) 6 (5.1%) 1 (1.6%) Study 2 Study 2 (NCT04518293) enrolled 2,242 patients on 0-3 antihypertensive medications at the screening visit.
Table from the label
| Widaplik (10 mg/1.25 mg/0.625 mg) (n=113) | Widaplik (20 mg/2.5 mg/1.25 mg) (n=118) | Placebo (n=62) | |
|---|---|---|---|
| Symptomatic hypotension n (%) | 4 (3.5%) | 6 (5.1%) | 0 (0%) |
| Sodium <135 mmol/L at week 4, n (%) | 4 (3.5%) | 1 (0.8%) | 0 (0%) |
| Potassium <3.5 mmol/L at week 4, n (%) | 4 (3.5%) | 6 (5.1%) | 1 (1.6%) |
— FDA label: Widaplik, Azurity Pharmaceuticals, Inc., effective July 3, 2026. This is part of the section. Read the full label on DailyMed →
Telmisartan, amlodipine and indapamide drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
NSAIDs: Increased risk of renal impairment and loss of anti-hypertensive effect (7.1) If simvastatin is co-administered with Widaplik, do not exceed doses greater than 20 mg daily of simvastatin (7.2) Do not co-administer aliskiren with Widaplik in patients with diabetes (7.1) 7.1 Drug Interactions with Telmisartan Aliskiren and other renin-angiotensin-aldosterone system (RAAS) inhibitors: Do not co-administer aliskiren with Widaplik in patients with diabetes.
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Most patients receiving the combination of two RAAS inhibitors do not obtain any additional benefit compared to monotherapy [see Contraindications (4)]. Avoid use of aliskiren with Widaplik in patients with renal impairment (GFR <60 mL/min) [see Warnings and Precautions (5.4)]. Digoxin: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Monitor digoxin levels when initiating, adjusting, and discontinuing Widaplik to keep the digoxin level within the therapeutic range. Lithium: Increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including telmisartan. Monitor serum lithium levels during concomitant use [see Drug Interactions with Indapamide (7.3)]. Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Widaplik and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including telmisartan may be attenuated by NSAIDs including selective COX-2 inhibitors. 7.2 Drug Interactions with Amlodipine Impact of other drugs on amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when Widaplik is co-administered with CYP3A inhibitors to determine the need for dose adjustment. CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when Widaplik is co-administered with CYP3A inducers. Sildenafil Monitor for hypotension when sildenafil is co-administered with Widaplik. Impact of amlodipine on other drugs Simvastatin: Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on Widaplik to 20 mg daily. Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered.
— FDA label: Widaplik, Azurity Pharmaceuticals, Inc., effective July 3, 2026. This is part of the section. Read the full label on DailyMed →
Telmisartan, amlodipine and indapamide dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
For initial treatment of hypertension, start with Widaplik (10 mg/ 1.25 mg/0.625 mg) or Widaplik (20 mg/2.5 mg/1.25 mg) orally once daily. Titrate up to a maximum dose of Widaplik (40 mg/5 mg/2.5 mg) orally once daily. (2.2) Dosage may be increased after 2 weeks to a maximum dose of 40 mg/5 mg/2.5 mg orally once daily to achieve more rapid control. (2.1) Almost all of the antihypertensive effect is apparent within 2 weeks of initiating treatment.
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(2.1) 2.1 General Considerations Dose orally once daily. Dosage must be individualized and may be increased after 2 weeks of treatment. Almost all the antihypertensive effect is apparent within 2 weeks of initiating treatment. Swallow tablets whole. Do not cut, crush, or chew tablets. Widaplik may be taken with or without food. Correct imbalances of intravascular volume- or salt-depletion, before initiating therapy with Widaplik [see Warnings and Precautions (5.3)]. 2.2 Recommended Dosage The recommended starting dosage is with Widaplik (10 mg/1.25 mg/0.625 mg) orally once daily or Widaplik (20 mg/2.5 mg/1.25 mg) orally once daily, based on anticipated need for blood pressure reduction. In elderly patients consider starting with Widaplik (10 mg/1.25 mg/0.625 mg) orally once daily [see Use in Specific Populations, Geriatric Use (8.5)]. The maximum recommended dose is Widaplik (40 mg/5 mg/2.5 mg) orally once daily.
— FDA label: Widaplik, Azurity Pharmaceuticals, Inc., effective July 3, 2026. Read the full label on DailyMed →
Telmisartan, amlodipine and indapamide in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary Widaplik can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin-aldosterone system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Clinical Considerations).
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Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin-aldosterone system from other antihypertensive agents. Studies in rats and rabbits showed fetotoxicity only at maternally toxic doses of telmisartan (see Data). When pregnancy is detected, discontinue Widaplik as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major malformations and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Telmisartan Use of drugs that act on the RAAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin-aldosterone system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking Widaplik during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. If oligohydramnios is observed, discontinue Widaplik, unless it is considered lifesaving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe neonates with histories of in utero exposure to Widaplik for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Indapamide Diuretics are known to cross the placental barrier and appear in cord blood.
— FDA label: Widaplik, Azurity Pharmaceuticals, Inc., effective July 3, 2026. This is part of the section. Read the full label on DailyMed →
When Telmisartan, amlodipine and indapamide should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Do not use in patients with anuria, known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs, or to any other component of this product. Do not co-administer aliskiren with Widaplik in patients with diabetes [see Drug Interactions (7.1)].
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Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs, or to any other component of this product (4) Do not co-administer aliskiren with Widaplik in patients with diabetes (4) Anuria (4)
— FDA label: Widaplik, Azurity Pharmaceuticals, Inc., effective July 3, 2026. Read the full label on DailyMed →
Telmisartan, amlodipine and indapamide overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Telmisartan Limited data are available with regard to overdosage in humans. The most likely manifestations of overdosage would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.
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Amlodipine Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported. Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the MRHD on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption. Indapamide Symptoms of overdosage of indapamide include nausea, vomiting, weakness, gastrointestinal disorders and disturbances of electrolyte balance. In severe instances, hypotension and depressed respiration may be observed. If this occurs, support of respiration and cardiac circulation should be instituted. There is no specific antidote. An evacuation of the stomach is recommended by emesis and gastric lavage after which the electrolyte and fluid balance should be evaluated carefully.
— FDA label: Widaplik, Azurity Pharmaceuticals, Inc., effective July 3, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Widaplik |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Azurity Pharmaceuticals, Inc.3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA219423 WIDAPLIK | Azurity | June 5, 2025 | 1, latest May 28, 2026 2026: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Widaplik, Azurity Pharmaceuticals, Inc., effective July 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →