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bravelle

Pharmaranks rates Bravelle 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Bravelle (Urofollitropin) is a medication used to treat Female Infertility, Polycystic Ovary Syndrome.

Urofollitropin · by Ferring Pharms Inc

72/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated October 10, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass

Key facts

Active ingredient
Urofollitropin
Form
Injectable
Strength
Urofollitropin 0.9%
Type
Prescription (Rx)
Brand or generic
Brand-name
Manufacturer
Ferring Pharms Inc
FDA application
BLA021484

May treat (source: NIH RxClass)

Dosage forms

Injectable

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

Same active ingredient, far cheaper. Is there a generic? →

Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

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Frequently asked questions

What does Bravelle treat?
Bravelle (Urofollitropin) may be used to treat female infertility, polycystic ovary syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How is Bravelle rated?
pharmaranks gives Bravelle a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
Is there a coupon or discount for Bravelle?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Bravelle. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Bravelle?
Bravelle is marketed by Ferring Pharms Inc. You can see Ferring Pharms Inc's full profile, rating, and other products on pharmaranks.
Is Bravelle a brand-name or generic drug?
Bravelle is a brand-name product with the active ingredient Urofollitropin.
Is Bravelle available over the counter?
No. Bravelle is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Bravelle come in?
Bravelle is currently marketed as injectable, per the FDA's National Drug Code Directory.
Is Bravelle FDA-registered?
Bravelle is on record with the U.S. FDA under application number BLA021484. You can verify this on its official FDA label.
Has Bravelle been recalled by the FDA?
Bravelle has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Bravelle safe?
There's no single safe-or-not verdict. pharmaranks gives Bravelle a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

What people report to the FDA about UROFOLLITROPIN

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 153 reports naming UROFOLLITROPIN — the active ingredient in Bravelle, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • ovarian hyperstimulation syndrome78 reports
  • abdominal distension30 reports
  • abdominal pain24 reports
  • nausea13 reports
  • diarrhoea12 reports
  • drug exposure during pregnancy11 reports
  • dyspnoea11 reports
  • vomiting11 reports

Read these as a signal, not a rate. A report does not mean UROFOLLITROPIN caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.

Source: openFDA drug/event (FAERS), retrieved September 26, 2026.

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bravelle

72/100