tornalate
Pharmaranks rates Tornalate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Tornalate (Bitolterol Mesylate) is a medication used to treat Asthma, Bronchial Spasm.
Bitolterol Mesylate · by Sanofi Aventis US
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
- Bitolterol Mesylate
- Form
- Solution, Spray/Inhaler, metered
- Strength
- Bitolterol Mesylate 0.2%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- asthma, bronchial spasm
- Manufacturer
- Sanofi Aventis US
- FDA application
- NDA019548
- Availability
- Discontinued (per FDA)
May treat (source: NIH RxClass)
Dosage forms
Solution and Spray/Inhaler, metered
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 Tornalate treat?
- Tornalate (Bitolterol Mesylate) may be used to treat asthma, bronchial spasm, 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 Tornalate rated?
- pharmaranks gives Tornalate a composite score of 3.5 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 Tornalate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tornalate. 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 Tornalate?
- Tornalate is marketed by Sanofi Aventis US. You can see Sanofi Aventis US's full profile, rating, and other products on pharmaranks.
- Is Tornalate a brand-name or generic drug?
- Tornalate is a brand-name product with the active ingredient Bitolterol Mesylate.
- Is Tornalate available over the counter?
- No. Tornalate 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 Tornalate come in?
- Tornalate is currently marketed as solution and spray/inhaler, metered, per the FDA's National Drug Code Directory.
- Is Tornalate FDA-registered?
- Tornalate is on record with the U.S. FDA under application number NDA019548. You can verify this on its official FDA label.
- Has Tornalate been recalled by the FDA?
- Tornalate 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 Tornalate safe?
- There's no single safe-or-not verdict. pharmaranks gives Tornalate a recall-safety score of 70/100, 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 BITOLTEROL MESYLATE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2 reports naming BITOLTEROL MESYLATE — the active ingredient in Tornalate, and the FDA flagged 50% 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:
- drug hypersensitivity1 reports
- hemiparesis1 reports
- muscular weakness1 reports
- psychotic disorder1 reports
Read these as a signal, not a rate. A report does not mean BITOLTEROL MESYLATE 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 25, 2026.
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tornalate
70/100