zolmitriptan
Pharmaranks rates Zolmitriptan 3.3/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Zolmitriptan is a serotonin-1b and serotonin-1d receptor agonist used to treat Migraine Disorders.
Serotonin-1b and Serotonin-1d Receptor Agonist · by Zydus Pharms USA Inc
Generic of Zomig
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
- Zolmitriptan
- Form
- Spray/Inhaler, Spray/Inhaler, metered, Tablet, Tablet, orally disintegrating
- Strength
- Zolmitriptan 2.5MG · Zolmitriptan 5MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- migraine disorders
- Manufacturer
- Zydus Pharms USA Inc
- Half-life
- about 3 hours (how long it stays in your system)
- What the pharmacy pays
- ~$67.24 for 30 — not your price
- FDA application
- ANDA202890
What is Zolmitriptan?
From the FDA label:Zolmitriptan orally disintegrating tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5 -HT 1B/1D ) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure: The molecular formula is C 16 H 21 N 3 O 2 , representing a molecular weight of 287.36. Zolmitriptan, USP is white to off-white crystalline powder that is freely soluble to soluble in methanol and soluble in water, sparingly soluble in dichloromethane, practically insoluble in toluene. Each zolmitriptan orally disintegrating tablet USP, intended for oral administration,contains 2.5 mg or 5 mg of zolmitriptan USP. In addition, each tablet contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, gelatin, magnesium stearate,mannitol, microcrystalline cellulose, orange flavor, polacrilin potassium and sodium stearyl fumarate. Structural Formula
How to use
Zolmitriptan is sold in more than one form (Spray/Inhaler, Spray/Inhaler, metered, Tablet and Tablet, orally disintegrating), and each is dosed differently. The instructions below come from the FDA label for application ANDA202890 — follow the label that came with the product you were actually prescribed.
Recommended starting dose: 1.25 mg or 2.5 mg ( 2.1 ) Maximum single dose: 5 mg ( 2.1 ) May repeat dose after 2 hours if needed; not to exceed 10 mg in any 24 hour period ( 2.1 ) Do not break zolmitriptan orally disintegrating tablets ( 2.2 ) Moderate or Severe Hepatic Impairment: 1.25 mg recommended ( 2.3 , 8.6 ) 2.1 Dosing Information The recommended starting dose of zolmitriptan tablets is 1.25 mg or 2.5 mg. The 1.25 mg dose can be achieved by manually breaking the functionally-scored 2.5 mg tablet in half. The maximum recommended single dose of zolmitriptan tablets is 5 mg. In controlled clinical trials, a greater proportion of patients had headache response following a 2.5 mg or 5 mg dose than following a 1 mg dose. There was little added benefit from the 5 mg dose compared to the 2.5 mg dose, but adverse reactions were more frequent with the 5 mg dose. If the migraine has not resolved by 2 hours after taking zolmitriptan, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 10 mg in any 24-hour period. The safety of zolmitriptan in the treatment of an average of more than three migraines in a 30-day period has not been established. 2.2 Administration of Zolmitriptan Orally Disintegrating Tablets Instruct patients not to break zolmitriptan orally disintegrating tablets because they are…
Side effects
Most common adverse reactions ( > 5% and > placebo) were neck/throat/jaw pain/tightness/pressure, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals(USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are described elsewhere in other sections of the prescribing information: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina [see Warnings and Precautions ( 5.1 )]. Arrthymias [see Warnings and Precautions ( 5.2 )]. Chest and or Throat, Neck and Jaw Pain/Tightness/Pressure [see Warnings and Precautions ( 5.3 )]. Cerebrovascular Events [see Warnings and Precautions ( 5.4 )]. Other Vasospasm Reactions [see Warnings and Precautions ( 5.5 )]. Medication Overuse Headache [see Warnings and Precautions ( 5.6 )]. Serotonin Syndrome [see Warnings and Precautions ( 5.7 )]. Increase in Blood Pressure [see Warnings and Precautions ( 5.8 )]. Risks in Patients with Phenylketonuria [see Warnings and Precautions ( 5.9 )]. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the…
Warnings
Important safety information
Myocardial Ischemia/Infarction, and Prinzmetal Angina : Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) Arrhythmias : Discontinue zolmitriptan if occurs ( 5.2 ) Chest/Throat/Neck/Jaw Pain, Tightness, and Pressure : Generally not associated with myocardial ischemia; evaluate for CAD in patients at high risk ( 5.3 ) Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke : Disc33ontinue zolmitriptan if occurs ( 5.4 ) Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions : Discontinue zolmitriptan if occurs ( 5.5 ) Medication Overuse Headache : Detoxification may be necessary ( 5.6 ) Serotonin Syndrome : Discontinue zolmitriptan if occurs ( 5.7 , 7.4 ) Patients with Phenylketonuria : Zolmitriptan orally disintegrating tablets contain phenylalanine ( 5.9 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina Zolmitriptan is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD) . There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of zolmitriptan. Some of these reactions occurred in patients without known CAD. 5-HT 1 agonists including zolmitriptan may cause coronary artery vasospasm (Prinzmetal Angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving zolmitriptan. Do not administer zolmitriptan if there is evidence of CAD or coronary artery vasospasm [ see Contraindications ( 4 ) ]. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating the first zolmitriptan dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following zolmitriptan administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of zolmitriptan. 5.2 Arrhythmias Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5-HT 1 agonists. Discontinue zolmitriptan if these disturbances occur. Zolmitriptan is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [ see Contraindications ( 4 ) ]. 5.3 Chest, Throat, Neck and Jaw Pain/Tightness/Pressure As with other 5-HT 1 agonists, sensations of tightness, pain, and pressure in the chest, throat, neck, and jaw commonly occur after treatment with zolmitriptan and is usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. 5-HT 1 agonists including zolmitriptan are contraindicated in patients with CAD or Prinzmetal's variant angina [ see Contraindications ( 4 ) ] . 5.4 Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine, exclude other potentially serious neurological conditions. Zolmitriptan is contraindicated in patients with a history of stroke or transient ischemic attack [ see Contraindications ( 4 ) ]. 5.5 Other Vasospasm Reactions 5-HT 1 agonists, including zolmitriptan, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT 1 agonist, rule out a vasospastic reaction before receiving additional zolmitriptan doses [ see Contraindications ( 4 ) ]. Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT 1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT 1 agonists have not been clearly established. 5.6 Medication Overuse Headache Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. 5.7 Serotonin Syndrome Serotonin syndrome may occur with triptans, including zolmitriptan, particularly during coadministration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions ( 7.5 )] . Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) . The onset of symptoms usually rapidly occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue zolmitriptan if serotonin syndrome is suspected [see Drug Interactions ( 7.4 ) ]. 5.8 Increase in Blood Pressure Significant elevations in systemic blood pressure have been reported in patients treated with 5-HT 1 agonists including patients without a history of hypertension; very rarely, these increases in blood pressure have been associated with serious adverse reactions. In healthy subjects treated with 5 mg of zolmitriptan, an increase of 1 and 5 mmHg in the systolic and diastolic blood pressure, respectively, was seen. In a study of patients with moderate to severe liver impairment, 7 of 27 patients experienced 20 to 80 mmHg elevations in systolic and/or diastolic blood pressure after a dose of 10 mg of zolmitriptan . As with all triptans, blood pressure should be monitored in zolmitriptan-treated patients. Zolmitriptan is contraindicated in patients with uncontrolled hypertension [see Contraindications ( 4 ) ] . 5.9 Risks in Patients with Phenylketonuria Phenylalanine can be harmful to patients with phenylketonuria (PKU). Zolmitriptan orally disintegrating tablets contain phenylalanine (a component of aspartame). Each 2.5 mg orally disintegrating tablet contains 2.51 mg phenylalanine. Each 5 mg orally disintegrating tablet contains 5.01 mg phenylalanine.
Who should not take Zolmitriptan
History of coronary artery disease (CAD) or coronary vasospasm ( 4 ) Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 ) History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ( 4 ) Peripheral vascular disease ( 4 ) Ischemic bowel disease ( 4 ) Uncontrolled hypertension ( 4 ) Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan), or an ergotamine-containing medication ( 4 ) Monoamine oxidase (MAO)-A inhibitor used in past 2 weeks ( 4 ) Known hypersensitivity to zolmitriptan ( 4 ) Zolmitriptan orally disintegrating tablets are contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or c oronary artery vasospasm including Prinzmetal's angina [see Warnings and Precautions ( 5.1 ) ]. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 ) ]. History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [ see Warnings and Precautions ( 5.4 ) ]. Peripheral vascular disease (PVD) [ see Warnings and Precautions ( 5.5 ) ]. Ischemic bowel disease [ see Warnings and Precautions ( 5.5 ) ] Uncontrolled hypertension [see Warnings and Precautions ( 5.8 ) ]. Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions ( 7.1 , 7.3 ) ]. Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent use of a MAO-A inhibitor (that is within 2 weeks) [see Drug Interactions ( 7.2 ), Clinical Pharmacology ( 12.3 ) ]. Known hypersensitivity to zolmitriptan (angioedema and anaphylaxis seen) [see Adverse Reactions ( 6.2 ) ].
Overdose — what happens if you take too much
There is no experience with acute overdose of zolmitriptan. Clinical study subjects who received single 50 mg oral doses of zolmitriptan commonly experienced sedation. There is no specific antidote to zolmitriptan. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. The elimination half-life of zolmitriptan is 3 hours [see Clinical Pharmacology ( 12.1 ) ]; therefore, monitor patients after overdose with zolmitriptan for at least 15 hours or until symptoms or signs resolve. It is unknown what effect hemodialysis or peritoneal dialysis has on the plasma concentrations of zolmitriptan.
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
7.1 Ergot-containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine containing or ergot-type medications (like dihydroergotamine or methysergide) and zolmitriptan within 24 hours of each other is contraindicated [see Contraindications ( 4 ) ]. 7.2 MAO-A Inhibitors MAO-A inhibitors increase the systemic exposure of zolmitriptan and its active N-desmethyl metabolite. Therefore, the use of zolmitriptan in patients receiving MAO-A inhibitors is contraindicated [see Contraindications ( 4 ), Clinical Pharmacology ( 12.3 ) ] . 7.3 5-HT1B/1D agonists Concomitant use of other 5-HT 1B/1D agonists (including triptans) within 24 hours of zolmitriptan treatment is contraindicated because the risk of vasospastic reactions may be additive [see Contraindications ( 4 ) ]. 7.4 Selective Serotonin Reuptake Inhibitors and Serotonin Norepinephrine Reuptake Inhibitors Cases of life-threatening serotonin syndrome have been reported during coadministration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions ( 5.7 ) ]. 7.5 Cimetidine Following administration of cimetidine, the half-life and blood levels of zolmitriptan and its active N-desmethyl metabolite were approximately doubled [see Clinical Pharmacology ( 12.3 ) ] . If cimetidine and zolmitriptan are used concomitantly, limit the maximum single dose of zolmitriptan to 2.5 mg, not to exceed 5 mg in any 24-hour period [see Dosage and Administration, ( 2.4 ), Clinical Pharmacology ( 12.3 ) ].
Storing Zolmitriptan, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store zolmitriptan tablets at 20-25°C (68-77°F) [see USP Controlled Room Temperature].”
- “Store zolmitriptan tablets at 20-25°C (68-77°F) [see USP Controlled Room Temperature] and away from children.”
- “Store zolmitriptan tablets at controlled room temperature, 20°C to 25°C (68 °F to 77°F) [see USP Controlled Room Temperature].”
How long does Zolmitriptan stay in your body?
The elimination half-life of zolmitriptan is about 3 hours — 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. Zolmitriptan has an ACTIVE metabolite, N-desmethyl-zolmitriptan, that is 2 to 6 times more potent at the 5-HT1B/1D receptor than the parent and reaches plasma levels about two-thirds those of zolmitriptan, so it contributes a substantial part of the effect. Its elimination half-life is also approximately 3 hours per the label (it does not outlast the parent). Special populations: pharmacokinetics in healthy elderly (65-76 yr) were similar to younger adults. Renal impairment - after oral dosing, renal clearance fell about 25% in severe impairment (CrCl 5-25 mL/min), with no significant change in moderate impairment (nasal-spray data not evaluated). Hepatic impairment - in SEVERE hepatic impairment, oral zolmitriptan AUC rose about 3-fold and Cmax about 1.5-fold with Tmax roughly doubling, so exposure (and effectively half-life) is markedly increased; dose reduction is advised. This is not a drug-test detection window and not dosing guidance.
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: Zolmitriptan nasal spray - DailyMed FDA label (Clinical Pharmacology 12.3).
Drug class
How this class works, per Triptans - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Zolmitriptan ranks — best-rated serotonin-1b and serotonin-1d receptor agonist for:
Dosage forms
Spray/Inhaler, Spray/Inhaler, metered, Tablet and Tablet, orally disintegrating
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Zolmitriptan treat?
- Zolmitriptan (Zolmitriptan) may be used to treat migraine disorders, 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 Zolmitriptan work?
- Zolmitriptan is a serotonin-1b and serotonin-1d receptor agonist. These migraine drugs (triptans) switch on serotonin 5-HT1B/1D receptors: they tighten the dilated blood vessels around the brain and quiet the trigeminal nerve pathway, blocking the release of pain-signaling molecules that drive a migraine attack.
- How is Zolmitriptan rated?
- pharmaranks gives Zolmitriptan 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 Zolmitriptan 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 $67.24 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 Zolmitriptan?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Zolmitriptan. To pay less, Zolmitriptan 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 Zolmitriptan?
- Zolmitriptan is marketed by Zydus Pharms USA Inc. You can see Zydus Pharms USA Inc's full profile, rating, and other products on pharmaranks.
- Is Zolmitriptan a brand-name or generic drug?
- Zolmitriptan is a generic medication; its active ingredient is Zolmitriptan. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Zolmitriptan available over the counter?
- No. Zolmitriptan 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 Zolmitriptan come in?
- Zolmitriptan is currently marketed as spray/inhaler, spray/inhaler, metered, tablet and tablet, orally disintegrating, per the FDA's National Drug Code Directory.
- What class of drug is Zolmitriptan?
- Zolmitriptan is classified as serotonin-1b and serotonin-1d receptor agonist, per the FDA's Established Pharmacologic Class.
- Is Zolmitriptan FDA-registered?
- Zolmitriptan is on record with the U.S. FDA under application number ANDA202890. You can verify this on its official FDA label.
- Has Zolmitriptan been recalled by the FDA?
- Zolmitriptan 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 Zolmitriptan safe?
- There's no single safe-or-not verdict. pharmaranks gives Zolmitriptan a recall-safety score of 66/100, 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 Zolmitriptan?
- Zolmitriptan's side effects are taken directly from its FDA label. From the label: Most common adverse reactions ( > 5% and > placebo) were neck/throat/jaw pain/tightness/pressure, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals(USA) Inc.… 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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zolmitriptan
66/100