pro-banthine
Pharmaranks rates Pro-Banthine 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Pro-Banthine (Propantheline Bromide) is a medication used to treat Urinary Bladder Diseases, Pancreatitis, Peptic Ulcer, Spasm.
Propantheline Bromide · by Shire
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 →
Key facts
- Active ingredient
- Propantheline Bromide
- Form
- Tablet, Injectable
- Strength
- Propantheline Bromide 15MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Propantheline Bromide 7.5MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons**
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- urinary bladder diseases, pancreatitis, peptic ulcer
- Manufacturer
- Shire
- FDA application
- NDA008732
- Availability
- Discontinued (per FDA)
May treat (source: NIH RxClass)
- urinary bladder diseases
- pancreatitis
- peptic ulcer
- spasm
- urethral diseases
- irritable bowel syndrome
Dosage forms
Tablet and 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.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Pro-Banthine treat?
- Pro-Banthine (Propantheline Bromide) may be used to treat urinary bladder diseases, pancreatitis, peptic ulcer, spasm, urethral diseases, irritable bowel 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 Pro-Banthine rated?
- pharmaranks gives Pro-Banthine 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 Pro-Banthine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Pro-Banthine. 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 Pro-Banthine?
- Pro-Banthine is marketed by Shire. You can see Shire's full profile, rating, and other products on pharmaranks.
- Is Pro-Banthine a brand-name or generic drug?
- Pro-Banthine is a brand-name product with the active ingredient Propantheline Bromide.
- Is Pro-Banthine available over the counter?
- No. Pro-Banthine 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 Pro-Banthine come in?
- Pro-Banthine is currently marketed as tablet and injectable, per the FDA's National Drug Code Directory.
- Is Pro-Banthine FDA-registered?
- Pro-Banthine is on record with the U.S. FDA under application number NDA008732. You can verify this on its official FDA label.
- Has Pro-Banthine been recalled by the FDA?
- Pro-Banthine 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 Pro-Banthine safe?
- There's no single safe-or-not verdict. pharmaranks gives Pro-Banthine 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 PROPANTHELINE BROMIDE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 126 reports naming PROPANTHELINE BROMIDE — the active ingredient in Pro-Banthine, and the FDA flagged 83% 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:
- dyspnoea11 reports
- hypotension11 reports
- sopor10 reports
- confusional state8 reports
- epistaxis8 reports
- acidosis7 reports
- drug hypersensitivity7 reports
- sensation of foreign body7 reports
Read these as a signal, not a rate. A report does not mean PROPANTHELINE BROMIDE 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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pro-banthine
72/100