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NITROSTAT® (nitroglycerin) Highlights


These highlights do not include all the information needed to use NITROSTAT safely and effectively. See full prescribing information for NITROSTAT

NITROSTAT (nitroglycerin) sublingual tablet
Initial U.S. Approval: 1981


NITROSTAT is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. (1)


  • At the onset of an attack, administer one tablet under the tongue or buccal pouch. One additional tablet may be administered every 5 minutes as needed. No more than 3 total tablets are recommended within a 15 minute period. (2)
  • If chest pain persists after three tablets, seek prompt medical attention. (2)
  • May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. (2)


Sublingual tablets, 0.3 mg; 0.4 mg; 0.6 mg (3)


  • Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. (4.1, 7.1)
  • Severe anemia (4.2)
  • Increased intracranial pressure (4.3)
  • Hypersensitivity to NITROSTAT or to other nitrates or nitrites or any excipient (4.4)
  • Circulatory failure and shock (4.5)


  • Tolerance: Excessive use may lead to tolerance. (5.1)
  • Hypotension: Severe hypotension may occur. (5.2)


Most common adverse reactions occurring at a frequency greater than 2% are headache, dizziness and paresthesia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or


Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. (7.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2018

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Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or

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