isopto carpine
Pharmaranks rates Isopto Carpine 3.3/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Isopto Carpine (Pilocarpine Hydrochloride) is a cholinergic receptor agonist used to treat Head and Neck Neoplasms, Xerostomia, Angle-Closure Glaucoma, Mydriasis.
Pilocarpine Hydrochloride · by Sandoz
Available as a generic: Pilocarpine Hydrochloride
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
- Pilocarpine Hydrochloride
- Drug class
- Cholinergic Receptor Agonist
- Form
- Drops
- Strength
- Pilocarpine Hydrochloride 1% · Pilocarpine Hydrochloride 2% · Pilocarpine Hydrochloride 4%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Sandoz
- What the pharmacy pays
- ~$0.38 per ml — not your price
- FDA application
- NDA200890
What is Isopto Carpine?
From the FDA label:Pilocarpine hydrochloride ophthalmic solution is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure: Established name: pilocarpine hydrochloride Chemical name: 2(3 H )-furanone, 3-ethyldihydro-4-[(1-methyl-1 H -imidazol-5-yl)-methyl]- monohydrochloride, (3S- cis )-. Molecular Formula: C 11 H 16 N 2 O 2 • HCl; Molecular Weight: 244.72 g/mol. Each mL of contains: Active: pilocarpine hydrochloride 1% (10 mg/mL), 2% (20 mg/mL), or 4% (40 mg/mL). Preservative: benzalkonium chloride 0.01%. Inactives: hypromellose 2910, boric acid, sodium citrate, sodium chloride (present in 1% only); hydrochloric acid and/or sodium hydroxide (to adjust pH); purified water. Pilocarpine hydrochloride ophthalmic solution has a pH of 3.5 to 5.5 and an osmolality of 290 to 350 mOsm/kg (1% and 2% products) and 550 to 600 mOsm/kg (4% product). Chemical Diagram
How to use
Instill one drop in the eye(s) up to four times daily. ( 2 ) 2.1 Reduction of Elevated IOP in Patients With Open-Angle Glaucoma or Ocular Hypertension One drop of pilocarpine hydrochloride ophthalmic solution 1%, 2%, or 4% should be applied topically in the eye(s) up to four times daily. Pilocarpine-naïve patients should be started on the 1% concentration as higher concentrations are often not tolerated initially. The frequency of instillation and concentration of pilocarpine hydrochloride ophthalmic solution are determined by the severity of the elevated intraocular pressure and miotic response of the patient. To limit systemic exposure to pilocarpine, patients may be instructed to perform punctal occlusion for 2 minutes after instillation of pilocarpine hydrochloride ophthalmic solution. 2.2 Management of Acute Angle-Closure Glaucoma Prior to pilocarpine hydrochloride ophthalmic solution use, treatment with secretory suppressants and hyperosmotic agents may be needed to lower IOP below 50 mmHg and relieve iris ischemia. For initial management of acute angle-closure glaucoma, one drop of pilocarpine hydrochloride ophthalmic solution 1% or 2% may be applied topically in the eye(s) up to three times over a 30-minute period. If laser iridoplasty or iridomy is used to break the attack, one drop of pilocarpine hydrochloride ophthalmic solution 4% should be administered prior to…
Side effects
Most common adverse reactions are headache/browache, accommodative change, eye irritation, eye pain, blurred vision, and/or visual impairment. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure in four controlled clinical trials of 90 days to 2 years duration in 317 patients diagnosed with open-angle glaucoma or ocular hypertension. In the four clinical trials, patients were treated with pilocarpine hydrochloride ophthalmic solution 2%, two to four times daily or with pilocarpine 1%, 1.75%, or 2% in fixed combination with betaxolol 0.25%, two or three times daily. The most frequently reported adverse reactions occurring in ≥ 5% of patients in the pilocarpine 2% populations were: headache/brow ache, accommodative change, blurred vision, eye irritation, visual impairment (dim, dark, or “jumping” vision), and eye pain. The adverse reaction profile reported for the use of pilocarpine hydrochloride ophthalmic solution in pediatric patients is comparable to that…
Warnings
Important safety information
Poor Illumination : Exercise caution in night driving and other hazardous occupations in poor illumination. ( 5.1 ) • Preexisting Retinal Disease : Rare cases of retinal detachment have been reported; a thorough examination of the retina, including funduscopy is advised in all patients prior to the initiation of therapy. ( 5.2 ) • Iritis : Caution is advised in patients with iritis. ( 5.3 ) • Congenital Glaucoma : Caution is advised in pediatric patients with primary congenital glaucoma for control of IOP as cases of a paradoxical increase in IOP have been reported. ( 5.4 ) 5.1 Poor Illumination Patients should be advised to exercise caution in night driving and other hazardous occupations in poor illumination. In addition, miotics may cause accommodative spasm. Patients should be advised not to drive or use machinery if vision is not clear. 5.2 Preexisting Retinal Disease As with all miotics, rare cases of retinal detachment have been reported when used in certain susceptible individuals and those with preexisting retinal disease; therefore, a thorough examination of the retina including funduscopy is advised in all patients prior to the initiation of therapy. 5.3 Iritis Pilocarpine hydrochloride ophthalmic solution is not recommended to be used when iritis is present. 5.4 Primary Congenital Glaucoma Caution is advised when using pilocarpine hydrochloride ophthalmic solution in pediatric patients with primary congenital glaucoma for control of IOP as cases of a paradoxical increase in IOP have been reported. In addition, the use of pilocarpine hydrochloride ophthalmic solution is not recommended in pediatric patients diagnosed with glaucoma secondary to anterior segment dysgenesis or uveitis (especially if uveitis is active). 5.5 Contact Lens Wear Contact lens wearers should be advised to remove their lenses prior to the instillation of pilocarpine hydrochloride ophthalmic solution and to wait 10 minutes after dosing before reinserting their contact lenses.
Who should not take Isopto Carpine
None. None. ( 4 )
Overdose — what happens if you take too much
Systemic toxicity following topical ocular administration of pilocarpine is rare, but occasionally patients who are sensitive may develop sweating and gastrointestinal overactivity following the suggested dosage and administration. Overdosage can produce sweating, salivation, nausea, tremors and slowing of the pulse and a decrease in blood pressure. In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration. For patients demonstrating severe poisoning, atropine, the pharmacologic antagonist to pilocarpine, should be used.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
How this class works, per Muscarinic Agonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Isopto Carpine ranks — best-rated cholinergic receptor agonist for:
Dosage forms
Drops
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 Isopto Carpine treat?
- Isopto Carpine (Pilocarpine Hydrochloride) may be used to treat head and neck neoplasms, xerostomia, angle-closure glaucoma, mydriasis, 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 does Isopto Carpine work?
- Isopto Carpine is a cholinergic receptor agonist. Cholinergic receptor agonists mimic acetylcholine and switch on its receptors, triggering the body's "rest and digest" responses. This boosts effects like saliva and tear flow, bladder and bowel emptying, and pupil constriction.
- How is Isopto Carpine rated?
- pharmaranks gives Isopto Carpine a composite score of 3.3 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Isopto Carpine cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.38 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Isopto Carpine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Isopto Carpine. 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 Isopto Carpine?
- Isopto Carpine is marketed by Sandoz. You can see Sandoz's full profile, rating, and other products on pharmaranks.
- Is Isopto Carpine a brand-name or generic drug?
- Isopto Carpine is a brand-name product with the active ingredient Pilocarpine Hydrochloride. Lower-cost generic equivalents containing Pilocarpine Hydrochloride are available — ask your pharmacist.
- Is Isopto Carpine available over the counter?
- No. Isopto Carpine 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 Isopto Carpine come in?
- Isopto Carpine is currently marketed as drops, per the FDA's National Drug Code Directory.
- What class of drug is Isopto Carpine?
- Isopto Carpine is classified as cholinergic receptor agonist, per the FDA's Established Pharmacologic Class.
- Is Isopto Carpine FDA-registered?
- Isopto Carpine is on record with the U.S. FDA under application number NDA200890. You can verify this on its official FDA label.
- Has Isopto Carpine been recalled by the FDA?
- Yes. Isopto Carpine has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Isopto Carpine safe?
- There's no single safe-or-not verdict. pharmaranks gives Isopto Carpine a recall-safety score of 66/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Isopto Carpine?
- Isopto Carpine's side effects are taken directly from its FDA label. From the label: Most common adverse reactions are headache/browache, accommodative change, eye irritation, eye pain, blurred vision, and/or visual impairment. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → 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 PILOCARPINE HYDROCHLORIDE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4,824 reports naming PILOCARPINE HYDROCHLORIDE — the active ingredient in Isopto Carpine, and the FDA flagged 58% 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:
- fatigue344 reports
- nausea309 reports
- headache289 reports
- dyspnoea257 reports
- diarrhoea242 reports
- arthralgia215 reports
- dizziness205 reports
- fall203 reports
Read these as a signal, not a rate. A report does not mean PILOCARPINE 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 27, 2026.
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isopto carpine
66/100