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Review Benzocaine View Benzocaine Adverse Event Reports: patient, weighting 154.3 lb, was diagnosed with gastrointestinal tube insertion and took Benzocaine 1 Spray X1 Topical To Back Of Throat Patient was h

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Chest Pain (2)
Nausia (1)
Ulcers (1)
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Showing 1-25 of 51 

Oxygen Saturation Decreased (8428644-0)
on Jun 06, 2012 Male patient from UNITED STATES , weighting 154.3 lb, was diagnosed with
  • gastrointestinal tube insertion
and was treated with Benzocaine Hurricaine Spray(View Usage). Patient experienced the following unwanted or unexpected effects: oxygen saturation decreased. Benzocaine Hurricaine Spray dosage: 1 Spray X1 Topical To Back Of Throat. Patient was hospitalized.

Respiratory Arrest, Cyanosis (8363129-1)
Patient was taking Benzocaine Oral Anethestic 20% Beutlich Pharmaceuticals (View Usage). Patient had the following side effects: respiratory arrest, cyanosis on May 14, 2012 from UNITED STATES Additional patient health information: Female patient , 83 years of age, weighting 103.2 lb, was diagnosed with and. Benzocaine Oral Anethestic 20% Beutlich Pharmaceuticals dosage: N/A. Patient was hospitalized.

Vulvovaginal Burning Sensation, Rash Macular, Urticaria, Vulvovaginal Swelling, Vulvovaginal Erythema, Hypersensitivity (8230492-1)
Adverse event was reported on Mar 12, 2012 by a Female patient taking Benzocaine 20% Crm 142 (View Usage) (Dosage: N/A) was diagnosed with
  • vulvovaginal pruritus
and. Location: UNITED STATES , weighting 250.0 lb, After Benzocaine was administered, patient had the following side effects: vulvovaginal burning sensation, rash macular, urticaria, vulvovaginal swelling, vulvovaginal erythema, hypersensitivity.

Methaemoglobinaemia (8144023-8)
on Feb 17, 2012 Male patient from UNITED STATES , 68 years of age, was treated with Benzocaine Spray (View Usage). Patient experienced the following unwanted or unexpected effects: methaemoglobinaemia. Benzocaine Spray dosage: N/A.


Hypersensitivity, Vulvovaginal Swelling, Vulvovaginal Burning Sensation, Rash Macular, Urticaria, Vulvovaginal Erythema (8116958-3)
on Jan 27, 2012 Female patient from UNITED STATES , weighting 250.0 lb, was diagnosed with
  • vulvovaginal pruritus
and was treated with Benzocaine 20% Crm 142(View Usage). Patient had the following side effects: hypersensitivity, vulvovaginal swelling, vulvovaginal burning sensation, rash macular, urticaria, vulvovaginal erythema. Benzocaine 20% Crm 142 dosage: N/A.

Pyrexia, Rash, Liver Injury (7801582-X)
Patient was taking Benzocaine (View Usage). After Benzocaine was administered, patient had the following side effects: pyrexia, rash (rash Questions), liver injury on Sep 26, 2011 from SPAIN Additional patient health information: Female patient , 23 years of age, . Benzocaine dosage: Unk.
Patient was taking other medications:

Malaise, Headache, Vision Blurred, Somnolence, Dizziness, Musculoskeletal Stiffness (7744757-0)
Adverse event was reported on Sep 12, 2011 by a Male patient taking Benzocaine (View Usage) (Dosage: One Dose) was diagnosed with
  • retching
and. Location: UNITED STATES , 64 years of age, weighting 171.0 lb, Patient experienced the following unwanted or unexpected effects: malaise, headache (headache Questions), vision blurred, somnolence, dizziness (dizziness Questions), musculoskeletal stiffness. Patient was hospitalized.

Methaemoglobinaemia, Hypoxia (7629102-3)
on Jul 22, 2011 Male patient from UNITED STATES , 47 years of age, weighting 181.0 lb, was treated with Benzocaine Hurricane Spray (View Usage). Patient had the following side effects: methaemoglobinaemia, hypoxia. Benzocaine Hurricane Spray dosage: N/A.

Paraesthesia (7592014-8)
on Nov 01, 2010 Female patient from UNITED STATES , 52 years of age, was treated with Benzocaine Topical Anesthetic (benzocaine)(View Usage). After Benzocaine was administered, patient had the following side effects: paraesthesia. Benzocaine Topical Anesthetic (benzocaine) dosage: N/A.
Patient was taking other medications:

Oxygen Saturation Decreased, Methaemoglobinaemia (7357298-X)
Patient was taking Benzocaine Topical Spray 20% Beutlich Pharmaceuticals (View Usage). Patient experienced the following unwanted or unexpected effects: oxygen saturation decreased, methaemoglobinaemia on Mar 11, 2011 from UNITED STATES Additional patient health information: Male patient , 58 years of age, weighting 163.1 lb, was diagnosed with
  • ethmoid sinus surgery
and. Benzocaine Topical Spray 20% Beutlich Pharmaceuticals dosage: 1-2 Sprays Once Top. Patient was hospitalized.

Swollen Tongue, Lip Swelling (7289601-3)
Adverse event was reported on Jan 31, 2011 by a Female patient taking Benzocaine (View Usage) (Dosage: N/A) . Location: UNITED STATES , 63 years of age, weighting 150.1 lb, Patient had the following side effects: swollen tongue, lip swelling.
Patient was taking other medications:

Confusional State, Anxiety, Acute Respiratory Distress Syndrome, Unresponsive To Stimuli, Hyperhidrosis, Cyanosis, Methaemoglobinaemia, Sinus Tachycardia, Cardiomegaly (7233148-7)
on Nov 22, 2010 Female patient from UNITED STATES , 78 years of age, was diagnosed with
  • echocardiogram
and was treated with Benzocaine (no Pref. Name) (View Usage). After Benzocaine was administered, patient had the following side effects: confusional state, anxiety (anxiety Questions), acute respiratory distress syndrome, unresponsive to stimuli, hyperhidrosis, cyanosis, methaemoglobinaemia, sinus tachycardia, cardiomegaly. Benzocaine (no Pref. Name) dosage: X1;top.
Patient was taking other medications:

Cyanosis, Methaemoglobinaemia, Somnolence (6654016-5)
on Mar 17, 2010 Female patient from UNITED STATES , 77 years of age, was diagnosed with
  • echocardiogram
and was treated with Benzocaine(View Usage). Patient experienced the following unwanted or unexpected effects: cyanosis, methaemoglobinaemia, somnolence. Benzocaine dosage: N/A.
Patient was taking other medications:

Methaemoglobinaemia (6645285-6)
Patient was taking Benzocaine Topical Spray 20% Beutlich (View Usage). Patient had the following side effects: methaemoglobinaemia on Mar 19, 2010 from UNITED STATES Additional patient health information: Male patient , 39 years of age, weighting 187.9 lb, was diagnosed with
  • local anaesthesia
and. Benzocaine Topical Spray 20% Beutlich dosage: Oropharingeal.

Methaemoglobinaemia (6400163-2)
Adverse event was reported on Oct 08, 2009 by a Female patient taking Benzocaine (View Usage) (Dosage: N/A) . Location: UNITED STATES , 73 years of age, weighting 149.0 lb, After Benzocaine was administered, patient had the following side effects: methaemoglobinaemia.

Dizziness, Skin Discolouration (6295020-9)
on Jul 31, 2009 Male patient from UNITED STATES , 48 years of age, weighting 218.3 lb, was diagnosed with
  • bronchoscopy
and was treated with Benzocaine Hurricaine (View Usage). Patient experienced the following unwanted or unexpected effects: dizziness (dizziness Questions), skin discolouration. Benzocaine Hurricaine dosage: ^prep For Bronchoscopy^ Once Inhal. Patient was hospitalized.

Blood Methaemoglobin Present (6188999-7)
on May 12, 2009 Male patient from UNITED STATES , 30 years of age, weighting 175.9 lb, was diagnosed with
  • endotracheal intubation
and was treated with Benzocaine Spray(View Usage). Patient had the following side effects: blood methaemoglobin present. Benzocaine Spray dosage: Spray X1 Topical.

Cyanosis, Incorrect Dose Administered, Irritability, Lethargy, Methaemoglobinaemia, Oxygen Saturation Decreased (6099930-7)
Patient was taking Benzocaine 20% (View Usage). After Benzocaine was administered, patient had the following side effects: cyanosis, incorrect dose administered, irritability, lethargy, methaemoglobinaemia, oxygen saturation decreased on Feb 27, 2009 from UNITED STATES Additional patient health information: Male patient , weighting 25.35 lb, was diagnosed with
  • oral herpes
and. Benzocaine 20% dosage: 1 Gm X1 Oropharingeal. Patient was hospitalized.

Methaemoglobinaemia, Post Procedural Complication (5826748-X)
Adverse event was reported on Jul 28, 2008 by a Male patient taking Benzocaine/tetracaine 20% Beutlich (View Usage) (Dosage: 1 Spray Once Top) was diagnosed with
  • echocardiogram
and. Location: UNITED STATES , weighting 165.8 lb, Patient experienced the following unwanted or unexpected effects: methaemoglobinaemia, post procedural complication.
Patient was taking other medications:

Methaemoglobinaemia (5612161-7)
on Jan 31, 2008 Female patient from UNITED STATES , 87 years of age, weighting 144.0 lb, was diagnosed with
  • echocardiogram
  • preoperative care
and was treated with Benzocaine (View Usage). Patient had the following side effects: methaemoglobinaemia. Benzocaine dosage: N/A. Patient was hospitalized.

Blood Methaemoglobin Present, Cardiac Procedure Complication, Cyanosis, Oxygen Saturation Decreased, Post Procedural Complication (5366299-2)
on Jun 19, 2007 Female patient from UNITED STATES , 53 years of age, was diagnosed with
  • echocardiogram
and was treated with Benzocaine Spray 20%(View Usage). After Benzocaine was administered, patient had the following side effects: blood methaemoglobin present, cardiac procedure complication, cyanosis, oxygen saturation decreased, post procedural complication. Benzocaine Spray 20% dosage: 3 Sprays Oropharinge.

Base Excess Increased, Blood Methaemoglobin Present, Blood Ph Increased, Cyanosis, Pco2 Decreased, Po2 Increased, Post Procedural Complication (5366291-8)
Patient was taking Benzocaine Spray 20% (View Usage). Patient experienced the following unwanted or unexpected effects: base excess increased, blood methaemoglobin present, blood ph increased, cyanosis, pco2 decreased, po2 increased, post procedural complication on Jun 19, 2007 from UNITED STATES Additional patient health information: Male patient , 72 years of age, was diagnosed with
  • echocardiogram
and. Benzocaine Spray 20% dosage: N/A.

Methaemoglobinaemia (5235415-5)
Adverse event was reported on Feb 08, 2007 by a Female patient taking Benzocaine 14% Spray (View Usage) (Dosage: Once) was diagnosed with
  • echocardiogram
and. Location: UNITED STATES , 77 years of age, Patient had the following side effects: methaemoglobinaemia.
Patient was taking other medications: Patient was hospitalized.

Blood Methaemoglobin Present, Cyanosis, Oxygen Saturation Decreased (5232809-9)
on Feb 06, 2007 Male patient from UNITED STATES , weighting 165.3 lb, was diagnosed with
  • intubation
and was treated with Benzocaine Spray -hurricaine- 20% Beutlich (View Usage). After Benzocaine was administered, patient had the following side effects: blood methaemoglobin present, cyanosis, oxygen saturation decreased. Benzocaine Spray -hurricaine- 20% Beutlich dosage: N/A.

Methaemoglobinaemia (5230966-1)
on Feb 05, 2007 Female patient from UNITED STATES , 55 years of age, was treated with Benzocaine/tetracaine(View Usage). Patient experienced the following unwanted or unexpected effects: methaemoglobinaemia. Benzocaine/tetracaine dosage: 1 Spray Once Other.

Showing 1-25 of 51 


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Side Effects reported to FDA: 51. View FDA Adverse Reports

Benzocaine safety alerts: 2011 2006

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Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia

[Posted 04/07/2011]

AUDIENCE: Family Practice, Pharmacy, Consumers

ISSUE: FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

BACKGROUND: Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.

RECOMMENDATIONS:

  • Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
  • Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.
  • Read the two Drug Safety Communications below for other specific recommendations for Healthcare Professionals, for Consumers and Caregivers and the Data Summary which supports these recommendations.

FDA is continuing to evaluate the safety of benzocaine products and the Agency will update the public when it has additional information. FDA will take appropriate regulatory actions as warranted. 

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[05/31/2012 - Consumer Update - FDA]
[01/2012 - Risk of Methemoglobinemia in the Medicine Cabinet - Pharmacy Today]
[04/07/2011 - Drug Safety Communication: Benzocaine Sprays - FDA]
[04/07/2011 - Drug Safety Communication: Benzocaine Gels, Liquids - FDA]
[04/07/2011 - Q&As - FDA]

En Espanol:

[08/23/2011 - Comunicado de Seguridad de Medicamentos - FDA]
[08/23/2011 - Preguntas y Respuestas - FDA]

Previous MedWatch Alert:

[02/13/2006]

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Benzocaine Adverse Reactions
Methaemoglobinaemia ( 29 Reports)
Cyanosis ( 14 Reports)
Oxygen Saturation Decreased ( 14 Reports)
Blood Methaemoglobin Present ( 8 Reports)
Post Procedural Complication ( 7 Reports)
Hypoxia ( 5 Reports)
Hypersensitivity ( 3 Reports)
Po2 Increased ( 3 Reports)
Blood Ph Increased ( 2 Reports)
Dizziness ( 2 Reports) Dizziness Questions
Dyspnoea ( 2 Reports)
Headache ( 2 Reports) Headache Questions
Lethargy ( 2 Reports)
Procedural Complication ( 2 Reports)
Rash ( 2 Reports) Rash Questions
Rash Macular ( 2 Reports)
Skin Discolouration ( 2 Reports)
Somnolence ( 2 Reports)
Urticaria ( 2 Reports)
Vulvovaginal Burning Sensation ( 2 Reports)
Vulvovaginal Erythema ( 2 Reports)
Vulvovaginal Swelling ( 2 Reports)
Acute Respiratory Distress Syndrome ( 1 Reports)
Anxiety ( 1 Reports) Anxiety Questions
Base Excess Increased ( 1 Reports)
Blood Pressure Diastolic Decreased ( 1 Reports)
Cardiac Procedure Complication ( 1 Reports)
Cardiomegaly ( 1 Reports)
Chapped Lips ( 1 Reports)
Confusional State ( 1 Reports)

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