aloprim
Pharmaranks rates Aloprim 3.1/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Aloprim (Allopurinol Sodium) is a xanthine oxidase inhibitor used to treat Gout.
Allopurinol Sodium · by Mylan
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
- Allopurinol Sodium
- Drug class
- Xanthine Oxidase Inhibitor
- Form
- Injectable
- Strength
- Allopurinol Sodium EQ 500MG BASE/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- gout
- Manufacturer
- Mylan
- Half-life
- about 1 to 2 hours (parent drug) (how long it stays in your system)
- What the pharmacy pays
- ~$1.57 for 30 — not your price
- FDA application
- NDA020298
What is Aloprim?
From the FDA label:ALOPRIM (allopurinol) for Injection, a xanthine oxidase inhibitor, is a sterile, white, lyophilized powder or cake, in a single-dose vial for reconstitution. Each vial contains 500 mg of allopurinol equivalent to 580.7 mg of allopurinol sodium and 148 mg of sodium hydroxide as a solubilizer. Sodium hydroxide is also used as a pH adjuster. ALOPRIM (allopurinol) for Injection contains no preservatives. Allopurinol is a xanthine oxidase inhibitor. The chemical name for allopurinol sodium is 1,5-dihydro-4 H -pyrazolo[3,4- d ]pyrimidin-4-one monosodium salt. It is a white amorphous mass with a molecular weight of 158.09 and molecular formula C 5 H 3 N 4 NaO. The structural formula is: The pKa of allopurinol sodium is 9.31. Allopurinol Structural Formula
How to use
Recommended Dosage ( 2.2 ) Adult Patients 200 mg/m 2 /day to 400 mg/m 2 /day Maximum 600 mg/day Pediatric Patients Starting Dose 200 mg/m 2 /day Maximum 400 mg/day • Recommended Dosage in Adult Patients with Renal Impairment ( 2.2 , 5.2 , 8.6 ) Creatinine Clearance Recommended Daily Dose 10 to 20 mL/min 200 mg/day Less than 10 mL/min 100 mg/day On dialysis 50 mg every 12 hours, or 100 mg every 24 hours 2.1 Recommended Dosage Initiate therapy with ALOPRIM 24 to 48 hours before the start of chemotherapy known to cause tumor cell lysis. Additionally, administer fluids sufficient to yield a daily urinary output of at least two liters in adults with a neutral or, preferably, slightly alkaline urine. The recommended daily dose of ALOPRIM is shown in Table 1. Administer the daily dose as single infusion or in equally divided infusions at 6-, 8-, or 12-hour intervals at a rate appropriate for the volume of infusate. Table 1: Recommended Daily Dose of ALOPRIM Adult Patients 200 mg/m 2 /day to 400 mg/m 2 /day intravenously Maximum 600 mg/day Pediatric Patients Starting Dose 200 mg/m 2 /day intravenously Maximum 400 mg/day The dosage of ALOPRIM to lower serum uric acid to normal or near-normal varies with the severity of the disease. Monitor serum uric acid levels at least daily and administer ALOPRIM at a dose and frequency to maintain the serum uric acid within the normal range.…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Skin Rash and Hypersensitivity [see Warnings and Precautions (5.1) ] • Renal Function Impairment [see Warnings and Precautions (5.2) ] • Hepatoxicity [see Warnings and Precautions (5.3) ] • Myelosuppression [see Warnings and Precautions (5.4) ] • Drowsiness [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence > 1%) are skin rash, nausea, vomiting, and renal failure/insufficiency. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 of ALOPRIM was evaluated in an uncontrolled compassionate use study of 1,378 patients with advanced malignancies requiring treatment with cytotoxic chemotherapy and in patients with other serious conditions. Adverse reactions were reported in 9% (125/1378) of the patients treated with ALOPRIM. The most common adverse reaction was skin rash. Two patients experience serious adverse reactions (decreased renal function and generalized…
Warnings
Important safety information
Skin Rash and Hypersensitivity: Discontinue ALOPRIM at the first appearance of skin rash or other signs which may indicate a hypersensitivity reaction. Allopurinol has been associated with serious and sometimes fatal dermatologic reactions. ( 5.1 ) • Renal Function Impairment: Patients with decreased renal function require lower doses of allopurinol. ( 5.2 ) • Hepatotoxicity: If signs and symptoms of hepatotoxicity develop, liver function evaluation should be performed. ( 5.3 ) • Myelosuppression: Bone marrow suppression has been reported with allopurinol. ( 5.4 ) • Drowsiness: Drowsiness has been reported in patients taking ALOPRIM. ( 5.5 ) 5.1 Skin Rash and Hypersensitivity Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients taking allopurinol [see Adverse Reactions (6.1) ] . These reactions occur in approximately 5 in 10,000 (0.05%) patients taking allopurinol. Other serious hypersensitivity reactions that have been reported include exfoliative, urticarial and purpuric lesions; generalized vasculitis; and irreversible hepatotoxicity. Discontinue ALOPRIM at the first appearance of skin rash or other signs which may indicate a hypersensitivity reaction. The HLA-B*58:01 allele is a genetic marker for severe skin reactions indicative of hypersensitivity to allopurinol. Patients who carry the HLA-B*58:01 allele are at a higher risk of allopurinol hypersensitivity syndrome (AHS), but hypersensitivity reactions have been reported in patients who do not carry this allele. The frequency of this allele is higher in individuals of African, Asian (e.g., Han Chinese, Korean, Thai), and Native Hawaiian/Pacific Islander ancestry [see Clinical Pharmacology (12.5) ] . The use of ALOPRIM is not recommended in HLA-B*58:01 positive patients unless the benefits clearly outweigh the risks. Prior to starting ALOPRIM, consider testing for the HLA-B*58:01 allele in genetically at-risk populations. Screening is generally not recommended in patients from populations in which the prevalence of HLA-B*58:01 is low, or in current allopurinol users, as the risk of SJS/TEN/DRESS is largely confined to the first few months of therapy, regardless of HLA-B*58:01 status. Hypersensitivity reactions to ALOPRIM may be increased in patients with decreased renal function receiving thiazide diuretics and ALOPRIM concurrently. In addition, concomitant use of the following drugs may increase the risk of skin rash, which may be severe: bendamustine, thiazide diuretics, ampicillin and amoxicillin [see Drug Interactions (7.1) ] . Patients should stop ALOPRIM and seek medical attention if they develop a rash. 5.2 Renal Function Impairment Treatment with ALOPRIM may result in renal impairment due to formation of xanthine calculi or due to precipitation of urates in patients receiving concomitant uricosuric agents. Patients with pre-existing renal disease, including renal impairment or history of kidney stones, may be at increased risk for worsening renal impairment due to xanthine calculi or precipitation of urates while receiving treatment with ALOPRIM. Monitor serum creatinine at least daily during the early stages of allopurinol administration. Maintain fluid intake sufficient to yield a urinary output of at least 2 liters per day in adults. In patients with severely impaired renal function or increase in uric acid concentration associated with decreased urate clearance, reduce the dosage of ALOPRIM [see Use In Specific Populations (8.6) and Dosage and Administration (2.1 , 2.2) ] . 5.3 Hepatotoxicity Cases of reversible clinical hepatotoxicity have been noted in patients taking oral allopurinol. In some patients, asymptomatic rises in serum alkaline phosphatase or serum transaminase have been observed. If anorexia, weight loss, or pruritus develop in patients on allopurinol, evaluate liver enzymes. In patients with pre-existing liver disease, monitor liver enzymes periodically during the early stages of therapy. Discontinue ALOPRIM in patients with elevated liver enzymes. 5.4 Myelosuppression Myelosuppression, manifested by anemia, leukopenia or thrombocytopenia, has been reported in patients receiving allopurinol [see Adverse Reactions (6.1) ] . The cytopenias have occurred from as early as 6 weeks to as late as 6 years after the initiation of allopurinol therapy. Discontinue use of ALOPRIM in patients with unexplained cytopenias. Concomitant use with allopurinol with cytotoxic drugs associated with myelosuppression may increase the risk of myelosuppression. Monitor blood counts more frequently [see Drug Interactions (7) ] . Concomitant use with allopurinol increases the exposure of either mercaptopurine or azathioprine which may increase the risk of myelosuppression. Reduce the dosage of mercaptopurine or azathioprine as recommended in the respective prescribing information when used concomitantly with ALOPRIM. [see Drug Interactions (7) ] . 5.5 Drowsiness Drowsiness has been reported in patients taking ALOPRIM [see Adverse Reactions (6.1) ] . Advise patients to avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting ALOPRIM or increasing the dose until they know how the drug affects them. Advise patients that the central nervous system depressant effects of ALOPRIM may be additive to those of alcohol and other CNS depressants.
Who should not take Aloprim
ALOPRIM is contraindicated in patients with a history of severe reaction to any formulation of allopurinol. Known hypersensitivity to allopurinol. ( 4 )
Overdose — what happens if you take too much
In the management of overdosage, there is no specific antidote for ALOPRIM. Both allopurinol and oxypurinol are dialyzable; however, the usefulness of hemodialysis or peritoneal dialysis in the management of an overdose of ALOPRIM is unknown.
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.
Interactions
Clinically important interactions with the drugs listed below were observed in patients undergoing treatment with an oral allopurinol formulation. • Capecitabine: Avoid the concomitant use of allopurinol ( 7.2 ). • Pegloticase: Discontinue and do not institute allopurinol therapy during treatment with pegloticase ( 7.2 ). • Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose as recommended in the respective prescribing information ( 7.2 ). • See full prescribing information for complete list of significant drug interactions ( 7 ). 7.1 Drugs Known to Affect the Occurrence of Skin Rash and Hypersensitivity Concomitant use of the following drugs may increase the risk of skin rash, which may be severe: bendamustine, thiazide diuretics, ampicillin and amoxicillin. Renal impairment may further increase risk with concomitant use of thiazide diuretics [see Warnings and Precautions (5.1) (5.2) and Clinical Pharmacology (12.2) ] . Monitor renal function and reduce the dose of ALOPRIM in patients with concomitant thiazide diuretic use and impaired renal function [see Dosage and Administration (2.2) ]. Discontinue ALOPRIM at the first appearance of skin rash or other signs which may indicate a hypersensitivity reaction when use concomitantly with these drugs. 7.2 Other Drugs Known to Have Clinically Important Drug Interactions with ALOPRIM Table 4: Interventions for Clinically Important Drug Interactions with ALOPRIM Capecitabine Clinical Impact Concomitant use with allopurinol may decrease concentration of capecitabine’s active metabolites, which may decrease capecitabine efficacy. Intervention Avoid the use of ALOPRIM during treatment with capecitabine. Cyclosporine Clinical Impact Concomitant use of allopurinol increases cyclosporine concentrations which may increase the risk of adverse reactions. Intervention Increase frequency of monitoring cyclosporine concentrations as reflected in the prescribing information when used concomitantly with ALOPRIM. Cytotoxic Agents Clinical Impact Concomitant use of allopurinol with cytotoxic agents increases bone marrow suppression among patients with neoplastic disease, except leukemia [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.2) ] . Intervention Blood count monitoring and regular physician follow-up recommended. Fluorouracil Clinical Impact Based on non-clinical data, allopurinol may decrease anti-tumor activity due to suppression of phosphorylation of 5-fluorouracil. Intervention Concomitant administration with fluorouracil should be avoided. Mercaptopurine or Azathioprine Clinical Impact Allopurinol inhibits xanthine oxidase mediated metabolism of mercaptopurine and azathioprine. Concomitant use of allopurinol increases the exposure of either mercaptopurine or azathioprine which may increase the risk of their adverse reactions including myelosuppression [see Warnings and Precautions (5.4) ] . Intervention Reduce the dosage of mercaptopurine or azathioprine as recommended in the respective prescribing information. Pegloticase Clinical Impact Concomitant use of ALOPRIM and pegloticase may potentially blunt the rise of serum uric acid levels and increase the risk of pegloticase related anaphylaxis in patients whose uric acid level increase to above 6 mg/dL. Intervention Discontinue and do not institute ALOPRIM therapy during treatment with pegloticase. Theophylline Clinical Impact Concomitant use of allopurinol doses greater than or equal to 600 mg/day may decrease the clearance of theophylline. Intervention Monitor and adjust theophylline doses as reflected in the prescribing information. Uricosuric Agents Clinical Impact Uricosuric agents increase the excretion of the active allopurinol metabolite oxypurinol. Concomitant use with uricosuric agents decreases oxypurinol exposure which may reduce the inhibition of xanthine oxidase by oxypurinol and increases the urinary excretion of uric acid. Intervention Monitor uric acid levels due to the increased chance of hypouricemic effects. Warfarin Clinical Impact Allopurinol may inhibit the metabolism of warfarin, possibly enhancing its anticoagulant effect. Intervention Patients on concomitant therapy should be monitored for excessive anticoagulation. The INR should be checked frequently and warfarin dosage adjusted accordingly when allopurinol is added to warfarin therapy.
How long does Allopurinol Sodium stay in your body?
The elimination half-life of allopurinol sodium is about 1 to 2 hours (parent drug) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The ~1-2 hour figure is for allopurinol itself, but it barely reflects how long the drug works. Allopurinol is converted to an active metabolite, oxypurinol (oxipurinol / alloxanthine), which is also a xanthine-oxidase inhibitor and is generally believed to mediate allopurinol's uric-acid-lowering action. Oxypurinol has a much longer plasma half-life of about 15 hours, so the therapeutic effect far outlasts the parent. Allopurinol is cleared by glomerular filtration, but oxypurinol is reabsorbed in the kidney tubules; in people with severely impaired renal function (or reduced urate clearance) the oxypurinol half-life is greatly prolonged.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: ZYLOPRIM (allopurinol) tablet — DailyMed FDA label, Clinical Pharmacology / Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
See how Aloprim ranks — best-rated xanthine oxidase inhibitor for:
Dosage forms
Injectable
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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Frequently asked questions
- What does Aloprim treat?
- Aloprim (Allopurinol Sodium) may be used to treat gout, 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 Aloprim rated?
- pharmaranks gives Aloprim a composite score of 3.1 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 Aloprim 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 $1.57 for 30, 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 Aloprim?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Aloprim. 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 Aloprim?
- Aloprim is marketed by Mylan. You can see Mylan's full profile, rating, and other products on pharmaranks.
- Is Aloprim a brand-name or generic drug?
- Aloprim is a brand-name product with the active ingredient Allopurinol Sodium.
- Is Aloprim available over the counter?
- No. Aloprim 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 Aloprim come in?
- Aloprim is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Aloprim?
- Aloprim is classified as xanthine oxidase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Aloprim FDA-registered?
- Aloprim is on record with the U.S. FDA under application number NDA020298. You can verify this on its official FDA label.
- Has Aloprim been recalled by the FDA?
- Yes. Aloprim 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 Aloprim safe?
- There's no single safe-or-not verdict. pharmaranks gives Aloprim a recall-safety score of 62/100, 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 Aloprim?
- Aloprim's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: • Skin Rash and Hypersensitivity [see Warnings and Precautions (5.1) ] • Renal Function Impairment [see Warnings and Precautions (5.2) ] • Hepatoxicity [see Warnings and Precautions (5.3) ] • Myelosuppres… 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 ALLOPURINOL SODIUM
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 160,473 reports naming ALLOPURINOL SODIUM — the active ingredient in Aloprim, and the FDA flagged 82% 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:
- diarrhoea8,934 reports
- fatigue8,496 reports
- dyspnoea8,149 reports
- nausea7,514 reports
- acute kidney injury6,897 reports
- pyrexia6,306 reports
- pneumonia5,839 reports
- asthenia5,777 reports
Read these as a signal, not a rate. A report does not mean ALLOPURINOL SODIUM 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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aloprim
62/100