cromolyn sodium
Pharmaranks rates Cromolyn Sodium 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cromolyn Sodium is a mast cell stabilizer used to treat Asthma, Bronchial Spasm, Conjunctivitis, Food Hypersensitivity.
Mast Cell Stabilizer · by Rising
Generic of Gastrocrom
⚠ FDA reports a current shortage of the concentrate form — availability differs between suppliers — see drug shortages →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
- Cromolyn Sodium
- Drug class
- Mast Cell Stabilizer
- Form
- Spray/Inhaler, Solution, Drops, Spray/Inhaler, metered
- Strength
- Cromolyn Sodium 100MG/5ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- asthma, bronchial spasm, conjunctivitis
- Manufacturer
- Rising
- What the pharmacy pays
- ~$0.60 per ml — not your price
- FDA application
- ANDA202583
What is Cromolyn Sodium?
From the FDA label:Each 5 mL ampule of Cromolyn Sodium Oral Solution, Concentrate contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium Oral Solution, Concentrate is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxy-trimethylene) dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate] The empirical formula is C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Its chemical structure is: Pharmacologic Category: Mast cell stabilizer Therapeutic Category: Antiallergic Cromolyn Structure
How to use
Cromolyn Sodium is sold in more than one form (Spray/Inhaler, Solution, Drops and Spray/Inhaler, metered), and each is dosed differently. The instructions below come from the FDA label for application ANDA202583 — follow the label that came with the product you were actually prescribed.
The usual starting dose is as follows: Adults and Adolescents (13 Years and Older): Two ampules four times daily, taken one-half hour before meals and at bedtime. Children 2-12 Years: One ampule four times daily, taken one-half hour before meals and at bedtime. Pediatric Patients Under 2 Years: Not recommended. If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day. Patients should be advised that the effect of Cromolyn Sodium Oral Solution, Concentrate therapy is dependent upon its administration at regular intervals, as directed. Maintenance Dose: Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained. Administration: Cromolyn Sodium Oral Solution, Concentrate should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions: Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. Stir solution. Drink all of the liquid.
Side effects
Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received Cromolyn Sodium Oral Solution, Concentrate during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Other Adverse Events: Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience. In most cases the available information is incomplete and attribution to the drug cannot be determined. The majority of these reports involve the gastrointestinal system and include: diarrhea, nausea, abdominal pain, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, esophagospasm. Other less commonly reported events (the majority representing only a single report) include the following: Skin: pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity Musculoskeletal: arthralgia, myalgia, stiffness/weakness of legs…
Warnings
Important safety information
The recommended dosage should be decreased in patients with decreased renal or hepatic function. Severe anaphylactic reactions may occur rarely in association with cromolyn sodium administration.
Who should not take Cromolyn Sodium
Cromolyn Sodium Oral Solution, Concentrate is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
Drug class
May treat (source: NIH RxClass)
See how Cromolyn Sodium ranks — best-rated mast cell stabilizer for:
Dosage forms
Spray/Inhaler, Solution, Drops 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
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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.
Compare alternatives
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Frequently asked questions
- What does Cromolyn Sodium treat?
- Cromolyn Sodium (Cromolyn Sodium) may be used to treat asthma, bronchial spasm, conjunctivitis, food hypersensitivity, mastocytosis, perennial allergic rhinitis, 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 Cromolyn Sodium rated?
- pharmaranks gives Cromolyn Sodium 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.
- How much does Cromolyn Sodium 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 $0.60 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 Cromolyn Sodium?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cromolyn Sodium. To pay less, Cromolyn Sodium is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cromolyn Sodium?
- Cromolyn Sodium is marketed by Rising. You can see Rising's full profile, rating, and other products on pharmaranks.
- Is Cromolyn Sodium a brand-name or generic drug?
- Cromolyn Sodium is a generic medication; its active ingredient is Cromolyn Sodium. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Cromolyn Sodium available over the counter?
- No. Cromolyn Sodium 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 Cromolyn Sodium come in?
- Cromolyn Sodium is currently marketed as spray/inhaler, solution, drops and spray/inhaler, metered, per the FDA's National Drug Code Directory.
- What class of drug is Cromolyn Sodium?
- Cromolyn Sodium is classified as mast cell stabilizer, per the FDA's Established Pharmacologic Class.
- Is Cromolyn Sodium FDA-registered?
- Cromolyn Sodium is on record with the U.S. FDA under application number ANDA202583. You can verify this on its official FDA label.
- Has Cromolyn Sodium been recalled by the FDA?
- Cromolyn Sodium 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 Cromolyn Sodium safe?
- There's no single safe-or-not verdict. pharmaranks gives Cromolyn Sodium 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.
- What are the side effects of Cromolyn Sodium?
- Cromolyn Sodium's side effects are taken directly from its FDA label. From the label: Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received Cromolyn Sodium Oral Solution,… 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.
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cromolyn sodium
72/100