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spravato

Pharmaranks rates Spravato 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Spravato (Esketamine Hydrochloride) is a medication used to treat Treatment-Resistant Depressive Disorder.

Esketamine Hydrochloride · by Janssen Pharms

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
Esketamine Hydrochloride
Form
Solution
Strength
Esketamine Hydrochloride EQ 28MG Base
Type
Prescription (Rx)
Brand or generic
Brand-name
Manufacturer
Janssen Pharms
FDA application
NDA211243

May treat (source: NIH RxClass)

Dosage forms

Solution

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

Ways to save

Ask for the generic

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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 Spravato treat?
Spravato (Esketamine Hydrochloride) may be used to treat treatment-resistant depressive disorder, 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 Spravato rated?
pharmaranks gives Spravato 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 Spravato?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Spravato. 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 Spravato?
Spravato is marketed by Janssen Pharms. You can see Janssen Pharms's full profile, rating, and other products on pharmaranks.
Is Spravato a brand-name or generic drug?
Spravato is a brand-name product with the active ingredient Esketamine Hydrochloride.
Is Spravato available over the counter?
No. Spravato 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 Spravato come in?
Spravato is currently marketed as solution, per the FDA's National Drug Code Directory.
Is Spravato FDA-registered?
Spravato is on record with the U.S. FDA under application number NDA211243. You can verify this on its official FDA label.
Has Spravato been recalled by the FDA?
Spravato 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 Spravato safe?
There's no single safe-or-not verdict. pharmaranks gives Spravato 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 ESKETAMINE HYDROCHLORIDE

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 45 reports naming ESKETAMINE HYDROCHLORIDE — the active ingredient in Spravato, and the FDA flagged 98% 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:

  • anaphylactic shock15 reports
  • agitation4 reports
  • constipation4 reports
  • functional gastrointestinal disorder4 reports
  • urinary hesitation4 reports
  • urinary retention4 reports
  • weight increased4 reports
  • drug level decreased3 reports

Read these as a signal, not a rate. A report does not mean ESKETAMINE HYDROCHLORIDE 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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spravato

72/100