Prescription medicine
Sumatriptan Brand names: Imitrex, Tosymra, Zembrace; first approved as Imitrex Statdose (Autoinjector)
Sumatriptan (Imitrex) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 39 generic labelers, and pharmacies paid $0.302 per sumatriptan succ 50 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $108.22 per unit (Tosymra 10 mg nasal spray).
- Generic listed
Check it at the source: the sumatriptan FDA label on DailyMed (effective May 12, 2026, Aurobindo Pharma Limited); the NDA 20080 record on Drugs@FDA; every sumatriptan label on DailyMed.
Highlights of the record
FDA label of May 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
Forms and strengths
- 5 mg
- 20 mg
- 25 mg
- 50 mg
- 100 mg
- 3 mg/.5ml
- 4 mg/.5ml
- 5 mg/.1ml
- 6 mg/.5ml
- 10 mg/.1ml
- 20 mg/.1ml
Tablet; film-coated tablet; injection; injection (solution); spray.
On the market
- Earliest approval on file
- December 28, 1992 Imitrex Statdose (Autoinjector), Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 40 first February 6, 2009; 24 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 43 of which 39 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- January 29, 2036 Zembrace Symtouch injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.302 per tablet Sumatriptan succ 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2013 0 Class I among all firms' recalls; latest April 13, 2022
- FAERS reports
- 44,847 through July 30, 2026
What is sumatriptan used for?
From the label: indications and usageSumatriptan 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 tablets are 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. […]
Conditions named in the indications of sumatriptan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Serotonin-1b and Serotonin-1d Receptor Agonist.
Source: FDA drug label (Sumatriptan), Aurobindo Pharma Limited, effective May 12, 2026 (SPL set b2503fff-c978-4efa-b1b4-d7740b6b26f2), via openFDA; the full label on DailyMed
What does the patient leaflet for sumatriptan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about sumatriptan tablets?Sumatriptan tablets can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death. Stop taking Sumatriptan tablets and get emergency medical help right away if you have any of the following symptoms of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded Sumatriptan tablets are not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you: have high blood pressure have high cholesterol levels smoke are overweight have diabetes have a family history of heart disease
From the patient leaflet: What should I avoid while taking sumatriptan tablets?Sumatriptan tablets can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.
From the patient leaflet: How should I store sumatriptan tablets?Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep sumatriptan tablets and all medicines out of the reach of children.
Source: FDA drug label (Sumatriptan), Aurobindo Pharma Limited, effective May 12, 2026 (SPL set b2503fff-c978-4efa-b1b4-d7740b6b26f2), via openFDA; the full label on DailyMed
Is there a generic for sumatriptan (Imitrex)?
The FDA approved the first generic sumatriptan on February 6, 2009. 40 generic applications are approved; 24 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists sumatriptan from 39 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Imitrex injection; a patent listed only for Zembrace Symtouch injection runs to January 29, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1992 earliest approval on file
- 2009 first generic approved
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sumatriptan (Imitrex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.302 per Sumatriptan succ 50 mg tablet, down 10% from $0.337 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sumatriptan succ 50 mg tablet (generic)
- Tosymra 10 mg nasal spray (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sumatriptan 20 mg nasal spray | Generic | $16.51 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -7% |
| Sumatriptan 5 mg nasal spray | Generic | $17.04 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -24% |
| Sumatriptan 6 mg/0.5 mL autoinj | Generic | $61.41 per mL | $30.71 per autoinj | -12% |
| Sumatriptan 6 mg/0.5 mL vial | Generic | $14.93 per mL | $7.47 per vial | +7% |
| Sumatriptan succ 100 mg tablet | Generic | $0.439 per tablet | $13.16 | -1% |
| Sumatriptan succ 25 mg tablet | Generic | $0.239 per tablet | $7.18 | -28% |
| Sumatriptan succ 50 mg tablet | Generic | $0.302 per tablet | $9.07 | -10% |
| Imitrex 100 mg tablet | Brand | $72.40 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $2,171.90 | no change |
| Imitrex 4 mg/0.5 mL pen inject | Brand | $463.07 per mL | $231.54 per single-dose pen | n/a |
| Imitrex 6 mg/0.5 mL cartridges | Brand | $436.80 per mL | $218.40 per cartridge | +0.2% |
| Imitrex 6 mg/0.5 mL pen inject | Brand | $460.05 per mL | $230.03 per single-dose pen | -0.3% |
| Tosymra 10 mg nasal spray | Brand | $108.22 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.2% |
| Zembrace symtouch 3 mg/0.5 mL | Brand | $384.09 per mL | n/a | +0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sumatriptan been recalled?
The FDA's Enforcement Report lists 6 recalls naming sumatriptan since 2013: 0 Class I (the most serious), 6 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| December 26, 2019 | Class II | Sun Pharmaceutical Industries, Inc. | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. |
| November 6, 2013 | Class II | GlaxoSmithKline, LLC. | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sumatriptan label say about other medicines?
The sumatriptan label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name sumatriptan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dihydroergotamine | contraindications | … (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 … |
| Ergotamine | warnings and precautions | Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). |
Other labels that name sumatriptan
Source: FDA drug label (Sumatriptan), Aurobindo Pharma Limited, effective May 12, 2026 (SPL set b2503fff-c978-4efa-b1b4-d7740b6b26f2), via openFDA; the full label on DailyMed
What do FAERS reports show for sumatriptan?
The FDA Adverse Event Reporting System holds 44,847 reports that list sumatriptan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,094 are coded as a death and 8,335 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sumatriptan?
11 other medicines are given the same way (oral) and in the same FDA class as sumatriptan or labeled mainly for the same use (migraine), the same class first. Migraine lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Rizatriptan | Migraine | 25 labelers | $0.335 per tablet 10 mg tablet | No current entry |
| Zolmitriptan | Migraine | 18 labelers | $1.02 per tablet 2.5 mg tablet | No current entry |
| Eletriptan | Migraine | 10 labelers | $1.75 per tablet 40 mg tablet | No current entry |
| Naratriptan | Migraine | 4 labelers | $1.08 per tablet 2.5 mg tablet | No current entry |
| Almotriptan | Migraine | 3 labelers | $16.86 per tablet 12.5 mg tablet | No current entry |
| Frovatriptan | Migraine | 4 labelers | $2.72 per tablet 2.5 mg tablet | A presentation being discontinued |
| Meloxicam and rizatriptan | Migraine | none listed | $122.64 per tablet 20-10 mg tablet | No current entry |
| Ubrogepant | Migraine | none listed | $109.11 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as sumatriptan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does sumatriptan compare with medicines for the same use?
4 side-by-side pages set sumatriptan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to sumatriptan
- 11 medicines for the same use
- Other triptans
- the pharmacologic class, with prices and generics
- Sumatriptan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other