
5 alpha-reductase inhibitorIndian prescription status not found in lists checkedJan Aushadhi listed
Dutasteride
डुटास्टेराइड
Dutasteride capsules treat symptoms of an enlarged prostate (BPH) in men. They can lower the risk of acute urinary retention and the need for BPH surgery. They must not be used in pregnancy, and pregnant women should not handle the capsules. It is not approved to prevent prostate cancer.
- Generic name
- Dutasteride
- Used for
- Treating symptomatic benign prostatic hyperplasia (enlarged prostate) in men.
- Label used
- Capsules label, oral, DailyMed set c78d18cf, effective 2026-08
- Prescription status (India)
- Not found in the Schedule H/H1/X/G lists we checked
- On NLEM 2022
- Not found in the list we checked
- NPPA price ceiling
- Not listed in the lists we checked
More facts
- Jan Aushadhi
- Listed (1 product row)
- Banned combinations
- None found in the list we checked
Compiled from official drug labels and Indian government sources. Always follow your doctor's or pharmacist's advice.
Safety at a glance
- AlcoholNot mentioned in label text
- PregnancyAvoid, per label textSee wording
- BreastfeedingCaution in label textSee wording
- DrivingCaution in label textSee wording
- KidneyNot mentioned in label text
- LiverNot mentioned in label text
Taken only from the label text cited on this page. "Not mentioned" does not mean safe. Ask your doctor or pharmacist.
What is dutasteride used for?
The label describes dutasteride for symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. It aims to improve symptoms, reduce the risk of acute urinary retention and reduce the need for BPH-related surgery.
It can also be used with the alpha-blocker tamsulosin. The label says it is not approved to prevent prostate cancer.
- Improves symptoms of an enlarged prostate
- Lowers risk of acute urinary retention
- Lowers need for BPH surgery
- Can be combined with tamsulosin
It is used to shrink an enlarged prostate and ease urinary symptoms in men.
Source1
How does dutasteride work?
Dutasteride stops the conversion of testosterone to dihydrotestosterone (DHT) by blocking both types of the 5 alpha-reductase enzyme.
DHT is the hormone mainly responsible for prostate growth, so lowering it helps the prostate shrink.
It lowers a hormone that makes the prostate grow.
Source1
How is dutasteride usually taken?
This page covers the US label for dutasteride capsules taken by mouth, with the dosing the label gives for adults.
This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.
For adults, the label describes one capsule once daily, alone or together with tamsulosin once daily.
Capsules should be swallowed whole, not chewed or opened, because the contents can irritate the mouth and throat. They may be taken with or without food.
- One capsule once daily
- Swallow whole; do not chew or open
- With or without food
- May be combined with tamsulosin
It is taken as one capsule once a day, swallowed whole.
Source1
What are the side effects of dutasteride?
Common
- The label lists impotence, reduced sex drive, ejaculation disorders and breast disorders such as enlargement and tenderness as the most common effects. Dizziness was also reported with tamsulosin.
- Impotence
- Reduced sex drive
- Ejaculation disorders
- Breast enlargement or tenderness
- Dizziness when combined with tamsulosin
Serious: get help
- The label also describes allergic reactions such as serious skin reactions and angioedema.
Common effects are sexual side effects and breast tenderness or enlargement.
Source1
Who should be careful with dutasteride?
The label says dutasteride must not be used in pregnancy because it may harm a male fetus. Women who are or may be pregnant should not handle the capsules. Blood donation should wait 6 months after the last dose.
It lowers PSA by about half, so any confirmed rise should be evaluated. It may increase the risk of high-grade prostate cancer.
- Not for use in pregnancy
- Pregnant women should not handle the capsules
- Do not donate blood until 6 months after the last dose
- Lowers PSA, which affects prostate cancer testing
- May increase risk of high-grade prostate cancer
- Not for use if allergic to 5 alpha-reductase inhibitors
It can harm a male fetus, and it lowers PSA test readings.
Source1
What medicines interact with dutasteride?
- Potent CYP3A4 inhibitors such as ritonavir
- Verapamil and diltiazem
- Tamsulosin and terazosin (no effect on levels)
- The label says caution is needed with potent, long-term CYP3A4 inhibitors such as ritonavir, because their effect on dutasteride has not been studied.
- Verapamil and diltiazem increase dutasteride exposure, but the label says no dose change is recommended.
- Tamsulosin and terazosin do not affect its levels.
No match in this label text. Ask your pharmacist about any medicine you take.
Caution applies with strong CYP3A4 inhibitors such as ritonavir.
Source1
How should dutasteride be stored?
The label gives a storage range of 20 to 25 degrees C.
Follow the storage line on your own pack, and keep medicines out of the reach of children.
Follow the storage instructions on your pack.
Source1
Is dutasteride a prescription medicine in India?
We did not find dutasteride in the Drugs Rules 1945 Schedule H, H1, X or G rows we checked, so we cannot state its Indian prescription status from our lists. Ask your pharmacist or doctor.
We did not find dutasteride on the National List of Essential Medicines 2022 in the list we checked.
The Jan Aushadhi (PMBJP) list we checked has 1 product row that mention dutasteride. We did not capture prices for them.
We did not find dutasteride in the Schedule H, H1, X or G rows we checked, not found on NLEM 2022.
Source2
What is the price ceiling for dutasteride?
Jan Aushadhi lists dutasteride products including Dutasteride Capsule IP 0.5 mg 0.5 mg. We have not shown a price for them. Check the pack and the seller for the actual price.
NPPA lists per-unit ceilings where a formulation is scheduled. Check the pack and seller.
Source2
Frequently asked questions
Can I drink alcohol while taking dutasteride?
The label we reviewed does not say. Ask your doctor or pharmacist.
Source1
Is dutasteride safe in pregnancy and breastfeeding?
The label says it is contraindicated in pregnancy because it may harm a male fetus. Ask your doctor or pharmacist about breastfeeding.
Source1
Should dutasteride be taken with food?
The label says capsules may be taken with or without food. Ask your doctor or pharmacist.
Source1
Can dutasteride affect driving or alertness?
The label we reviewed does not say. Ask your doctor or pharmacist.
Source1
Can children or older adults take dutasteride?
The label says it is not indicated for women, and does not describe use in children. Ask your doctor or pharmacist.
Source1
Is dutasteride on the NLEM and Jan Aushadhi list?
We did not find it on NLEM 2022. Yes, several dutasteride products are in the Jan Aushadhi list we checked.
Source2
Sources
- 1U.S. FDA-approved label (DailyMed) (c78d18cf-05df-4154-b2f9-39cc374ca9e3) Open source · 2026-10-15
- 2PMBJP (Jan Aushadhi) product list (p51:sno1124) Open source · 2026-10-15
Compiled by software from the sources above and checked by automated rules. Last checked: 2026-10-15 · How we use sources · Report a correction
This information is educational and is not a substitute for advice from your doctor or pharmacist. It does not tell you what dose you personally should take. In an emergency call 112.