sumatriptan 50 mg Tablet, Film Coated, 9-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin-1b and Serotonin-1d Receptor Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Sumatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes come with nausea or a strong reaction to sound and light). Sumatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the head, stopping pain signals from being sent to the brain, and stops the release of certain natural substances that cause pain, nausea, and other symptoms of migraines. Sumatriptan does not stop migraine attacks from coming or reduce the number of headaches you have.
Read the full MedlinePlus article ↗- Sumatriptan is specifically for migraine headaches — it's not a general pain reliever like ibuprofen. It's designed to stop a migraine attack once it's already started, with or wit...
- What exactly is sumatriptan for? Will it work on any headache?
- You don't need to wait until it's unbearable. Taking sumatriptan at the first sign of a migraine is generally the right move — don't wait it out. That said, it is meant for confirm...
- When should I take sumatriptan — do I have to wait until the headache is severe?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.300 | $2.70 / 9 tablets |
| Medicaid paysCMS SDUD · 12 mo | $6.59 | $59.32 / 9 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.8693 | $7.82 / 9 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sumatriptan Succinate 50 mg 00378-5631-59 | Mylan | 9 tablets | $0.299 | AB | Availability likely | — |
| Sumatriptan 50 mg 16714-0797-01 | NorthStar | 9 tablets | $0.299 | AB | Availability likely | — |
| sumatriptan 50 mgthis 64980-0661-91 | Rising | 9 tablets | $0.299 | AB | Availability likely | — |
| Sumatriptan Succinate 50 mg 65862-0147-36 | Aurobindo | 9 tablets | $0.299 | — | Availability likely | — |
| Sumatriptan 50 mg 69452-0345-72 | Bionpharma | 9 tablets | $0.299 | AB | Availability likely | — |
| Imitrex 50 mg 00173-0736-01 | GlaxoSmithKline | 9 tablets | $73.068 | AB | FDA listed | +24301% |
| Sumatriptan 50 mg 50090-1129-00 | A-S | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan Succinate 50 mg 51407-0012-09 | Golden | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan Succinate 50 mg 55111-0292-01 | Dr. | 100 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 55700-0936-09 | Quality | 9 tablets | — | AB | FDA listed | — |
| sumatriptan succinate 50 mg 62756-0521-01 | Sun | 9 tablets | — | — | FDA listed | — |
| Sumatriptan Succinate 50 mg 63187-0049-09 | Proficient | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 63187-0797-09 | Proficient | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 63304-0098-13 | SUN | 120 tablets | — | — | FDA listed | — |
| Sumatriptan 50 mg 68071-3350-09 | NuCare | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 68071-3525-09 | NuCare | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 68071-3802-09 | NuCare | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan Succinate 50 mg 68071-4562-09 | NuCare | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 68071-4815-09 | NuCare | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 68788-8619-09 | Preferred | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 68788-9547-09 | Preferred | 9 tablets | — | AB | FDA listed | — |
| sumatriptan succinate 50 mg 71205-0251-09 | Proficient | 1 tablet | — | — | FDA listed | — |
| Sumatriptan Succinate 50 mg 72189-0433-09 | Direct_Rx | 9 tablets | — | — | FDA listed | — |
| Sumatriptan Succinate 50 mg 76420-0093-09 | Asclemed | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 76420-0498-09 | Asclemed | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 80425-0318-01 | Advanced | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 80425-0475-01 | Advanced | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 82804-0169-09 | Proficient | 9 tablets | — | AB | FDA listed | — |
| Sumatriptan 50 mg 85766-0094-09 | Sportpharm | 9 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 64980-0661-27 | 3 BLISTER PACK in 1 CARTON (64980-661-27) / 9 TABLET, FILM COATED in 1 BLISTER PACK | $0.2995 / ea | $8.09 | 2025-05-05 | Active |
| 64980-0661-36 | 36 TABLET, FILM COATED in 1 BOTTLE (64980-661-36) | $0.2995 / ea | $10.78 | 2025-07-23 | Active |
| 64980-0661-91 You're viewing this | 1 BLISTER PACK in 1 CARTON (64980-661-91) / 9 TABLET, FILM COATED in 1 BLISTER PACK | $0.2995 / ea | $2.70 | 2025-05-05 | Active |
This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.2995 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 61% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 64980-0661-91?
What is the difference between NDC 64980-0661-91 and NDC 64980-0661-36?
What NDC number is used to bill for this package of sumatriptan 50 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Sumatriptan 25 mg, 50 mg and 100 mg tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks.
Sumatriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. Sumatriptan is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.
( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. ( 1 ) Not indicated for the prophylactic therapy of migraine attacks. ( 1 ) Not indicated for the treatment of cluster headache.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Single dose of 25-mg, 50-mg, or 100-mg tablet. ( 2.1 ) A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. ( 2.1 ) Maximum dose in a 24-hour period: 200 mg. ( 2.1 ) Maximum single dose should not exceed 50 mg in patients with mild to moderate hepatic impairment. ( 2.2 )
2.1Dosing Information The recommended dose of sumatriptan tablets is 25 mg, 50 mg, or 100 mg. Doses of 50mg and 100mg may provide a greater effect than the 25-mg dose, but doses of 100mg may not provide a greater effect than the 50-mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14) ] .
If the migraine has not resolved by 2 hours after taking sumatriptan tablets, 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 200 mg in a 24-hour period. Use after sumatriptan Injection If the migraine returns following an initial treatment with sumatriptan injection, additional single sumatriptan tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses.
The safety of treating an average of more than 4 headaches in a 30-day period has not been established.
2.2Dosing in Patients with Hepatic Impairment If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 25-mg Tablets : Round, White colored film-coated tablets debossed with “V” on one side and “22”on the other side. Each tablet contains 35 mg of sumatriptan succinate equivalent to 25 mg of sumatriptan. 50-mg Tablets: Round, White colored film-coated tablets debossed with “V” on one side and “23” on the other side.
Each tablet contains 70 mg of sumatriptan succinate equivalent to 50 mg of sumatriptan. 100-mg Tablets: Round, Pink colored film-coated tablets debossed with “V”’ on one side and “24”’ on the other side. Each tablet contains 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan.
Tablets: 25 mg, 50 mg, and 100 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Sumatriptan tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary 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 or 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 [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 ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions (7.1, 7.3) ] Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions (7.2) , Clinical Pharmacology (12.3) ] Hypersensitivity to sumatriptan tablets (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.9) ] Severe hepatic impairment [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] History of coronary artery disease or coronary artery vasospasm ( 4 ) 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 of an ergotamine containing medication ( 4 ) Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor ( 4 ) Hypersensitivity to sumatriptan tablets (angioedema and anaphylaxis seen) ( 4 ) Severe hepatic impairment ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. ( 5.1 ) Arrhythmias: Discontinue sumatriptan tablets if occurs. ( 5.2 ) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk.
( 5.3 ) Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue sumatriptan tablets if occurs. ( 5.4 ) Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue sumatriptan tablets if occurs. ( 5.5 ) Medication overuse headache: Detoxification may be necessary.
( 5.6 ) Serotonin syndrome: Discontinue sumatriptan tablets if occurs. ( 5.7 ) Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. ( 5.10 )
5.1Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina The use of sumatriptan tablets is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan tablets. Some of these reactions occurred in patients without known CAD.
Sumatriptan tablets may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan tablets. If there is evidence of CAD or coronary artery vasospasm, sumatriptan tablets are contraindicated.
For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of sumatriptan tablets in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of sumatriptan tablets. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of sumatriptan tablets.
5.2Arrhythmias 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 sumatriptan tablets if these disturbances occur. Sumatriptan tablets are contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.
5.3Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan tablets and are usually non cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of sumatriptan tablets is contraindicated in patients with CAD and those with Prinzmetal’s variant angina.
5.4Cerebrovascular 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. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA).
Discontinue sumatriptan tablets if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. Sumatriptan tablets are contraindicated in patients with a history of stroke or TIA.
5.5 Other Vasos…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the prescribing information: Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1) ] Arrhythmias [see Warnings and Precautions (5.2) ] Chest, throat, neck, and/or 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) ] Hypersensitivity reactions [see Contraindications (4) , Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥2% and >placebo) were paresthesia, warm/ cold sensation, chest pain/tightness/pressure and/or heaviness, neck /throat/jaw pain/tightness/pressure, other sensations of pain/pressure/tightness/heaviness, vertigo and malaise/fatigue.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 1 lists adverse reactions that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only treatment-emergent adverse reactions that occurred at a frequency of 2% or more in any group treated with sumatriptan tablets and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1. Adverse Reactions Reported by at Least 2% of Patients Treated with Sumatriptan Tablets and at a Greater Frequency than Placebo Adverse Reaction Percent of Patients Reporting Sumatriptan Tablets 25 mg (n = 417) Sumatriptan Tablets 50 mg (n = 771) Sumatriptan Tablets 100 mg (n = 437) Placebo (n = 309) Atypical sensations Paresthesia (all types) 5 3 3 6 5 2 6 3 3 4 2 2 Sensation warm/cold Pain and other pressure sensations Chest -pain/tightness/pressure and/or heaviness Neck/throat/jaw -pain/tightness/pressure Pain – location specified Other -pressure/tightness/heaviness 6 6 8 4 1 2 2 1 <1 2 3 <1 2 1 1 1 1 1 3 2 Neurological Vertigo <1 <1 2 <1 Other Malaise/fatigue 2 2 3 <1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients.
There were insufficient data to assess the impact of race on the incidence of adverse reactions.
6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of sumatriptan tablets, sumatriptan nasal spray and sumatriptan injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to sumatriptan or a combination of these factors.
Cardiovascular Hypotension, palpitations. Neurological Dystonia, tremor.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Ergot-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 sumatriptan tablets within 24 hours of each other is contraindicated.
7.2Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by 7-fold. Therefore, the use of sumatriptan tablets in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3) ].
7.3Other 5-HT 1 Agonists Because their vasospastic effects may be additive, coadministration of sumatriptan tablets and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated.
7.4Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )
8.1Pregnancy Risk Summary Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see Data) . In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see Data) .
In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.
Data Human Data: The Sumatriptan/Naratriptan/Treximet (sumatriptan and naproxen sodium) Pregnancy Registry, a population-based international prospective study, collected data for sumatriptan from January 1996 to September 2012. The Registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). The occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% CI: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% CI: 2.7% to 6.2%]).
The sample size in this study had 80% power to detect at least a 1.73- to 1.91-fold increase in the rate of major malformations. The number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis.
No other birth defect was reported for more than 2 infants in this group. In a study using data from the Swedish Medical Birth Register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. Of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% CI: 0.91 to 1.21]).
A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. Of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (OR 1.16 [95% CI: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (OR 1.83 [95% CI: 1.17 to 2.88]), each compared with the population comparison group.
Additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. Ani…
🆘 Overdosage ▾
10 OVERDOSAGE Patients in clinical trials (N = 670) received single oral doses of 140 to 300 mg without significant adverse reactions. Volunteers (N = 174) received single oral doses of 140 to 400 mg without serious adverse reactions. Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation and lacrimation.
The elimination half-life of sumatriptan is approximately 2.5 hours [see Clinical Pharmacology (12.3) ] , and therefore monitoring of patients after overdose with sumatriptan tablets should continue for at least 12 hours or while symptoms or signs persist. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sumatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
12.2Pharmacodynamics Blood Pressure Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see Warnings and Precautions (5.8) ]. Peripheral (Small) Arteries In healthy volunteers (N = 18), a trial evaluating the effects of sumatriptan on peripheral (small vessel) arterial reactivity failed to detect a clinically significant increase in peripheral resistance. Heart Rate Transient increases in blood pressure observed in some patients in clinical trials carried out during sumatriptan’s development as a treatment for migraine were not accompanied by any clinically significant changes in heart rate.
12.3Pharmacokinetics Absorption The mean maximum concentration following oral dosing with 25 mg is 18 ng/mL (range: 7 to 47 ng/mL) and 51 ng/mL (range: 28 to 100 ng/mL) following oral dosing with 100 mg of sumatriptan. This compares with a C max of 5 and 16 ng/mL following dosing with a 5- and 20-mg intranasal dose, respectively. The mean C max following a 6-mg subcutaneous injection is 71 ng/mL (range: 49 to 110 ng/mL).
The bioavailability is approximately 15%, primarily due to presystemic metabolism and partly due to incomplete absorption. The C max is similar during a migraine attack and during a migraine-free period, but the T max is slightly later during the attack, approximately 2.5 hours compared with 2.0 hours. When given as a single dose, sumatriptan displays dose proportionality in its extent of absorption (area under the curve [AUC]) over the dose range of 25 to 200 mg, but the C max after 100 mg is approximately 25% less than expected (based on the 25-mg dose).
Effect of Food: A food effect trial involving administration of sumatriptan tablets 100 mg to healthy volunteers under fasting conditions and with a high-fat meal indicated that the C max and AUC were increased by 15% and 12%, respectively, when administered in the fed state. Distribution Protein binding, determined by equilibrium dialysis over the concentration range of 10 to 1,000 ng/mL is low, approximately 14% to 21%. The effect of sumatriptan on the protein binding of other drugs has not been evaluated.
The apparent volume of distribution is
2.7L/kg. Metabolism In vitro studies with human microsomes suggest that sumatriptan is metabolized by MAO, predominantly the A isoenzyme. Most of a radiolabeled dose of sumatriptan excreted in the urine is the major metabolite indole acetic acid (IAA) or the IAA glucuronide, both of which are inactive.
Elimination The elimination half-life of sumatriptan is approximately 2.5 hours. Radiolabeled 14 C-sumatriptan administered orally is largely renally excreted (about 60%) with about 40% found in the feces. Most of the radiolabeled compound excreted in the urine is the major metabolite, IAA, which is inactive, or the IAA glucuronide.
Only 3% of the doses can be recovered as unchanged sumatriptan. Specific Populations Age: The pharmacokinetics of sumatriptan in the elderly (mean age: 72 years, 2 males and 4 females) and in subjects with migraine (mean age: 38 years, 25 males and 155 females) were similar to that in healthy male subjects (mean age: 30 years). Patients with Renal Impairment: The effect of renal impairment on the pharmacokinetics of sumatriptan has not been examined.
Patients with Hepatic Impairment: The liver plays an important role in the presystemic clearance of orally administered sumatriptan. Accordingly, the bioavailability of sumatriptan following oral administration may be marked…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan 25 mg, 50 mg and 100 mg tablets are supplied as film-coated, round shaped, tablets in the following strengths. Sumatriptan Tablets USP, 25 mg: Round, White colored film-coated tablets debossed with “V” on one side and “22”on the other side. They supplied as: Bottle pack of 36 tablets NDC 64980-660-36 Blister packs of 9 tablets (1 blister of 9 tablets) NDC 64980-660-91 Blister packs of 27 tablets (3 blisters of 9 tablets) NDC 64980-660-27 Sumatriptan Tablets USP, 50 mg: Round, White colored film-coated tablets debossed with “V” on one side and “23” on the other side.
They supplied as: Bottle pack of 36 tablets NDC 64980-661-36 Blister packs of 9 tablets (1 blister of 9 tablets) NDC 64980-661-91 Blister packs of 27 tablets (3 blisters of 9 tablets) NDC 64980-661-27 Sumatriptan Tablets USP, 100 mg: Round, Pink colored film-coated tablets debossed with “V”on one side and “24”' on the other side. They supplied as: Bottle pack of 36 tablets NDC 64980-662-36 Blister packs of 9 tablets (1 blister of 9 tablets) NDC 64980-662-91 Blister packs of 27 tablets (3 blisters of 9 tablets) NDC 64980-662-27 Store between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].
📋 Description ▾
11 DESCRIPTION Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT 1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The empirical formula is C 14 H 21 N 3 O 2 S•C 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate is a White or almost white powder that is readily soluble in water and in saline.
Each Sumatriptan tablets, USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. Each 25-mg and 50-mg tablet also contains hypromellose, titanium dioxide and triacetin.
Each 100-mg tablet also contains hypromellose, iron oxide red, titanium dioxide, and triacetin. FDA approved dissolution test specifications differ from USP. "Image Description"
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events Inform patients that sumatriptan tablets may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech, and should ask for medical advice if any indicative sign or symptoms are observed.
Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1 , 5.2 , 5.4 , 5.5 , 5.8) ]. Anaphylactic/Anaphylactoid Reactions Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan tablets. Such reactions can be life-threatening or fatal.
In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Contraindications (4) , Warnings and Precautions (5.9) ]. Concomitant Use with Other Triptans or Ergot Medications Inform patients that use of sumatriptan tablets within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4) , Drug Interactions (7.1 , 7.3) ]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome with the use of sumatriptan tablets or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) , Drug Interactions (7.4) ].
Medication Overuse Headache Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6) ]. Pregnancy Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations (8.1) ]. Lactation Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2) ] .
Ability to Perform Complex Tasks Treatment with sumatriptan tablets may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of sumatriptan tablets. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: VKT Pharma Private Limited Srikakulam District, India-532409.
ML No: 02/SKL/AP/2015/F/R Revised: 05/2025