DIBUCAINE: 90 Adverse Event Reports & Safety Profile
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Drug Class: Allergens [CS] · Route: TOPICAL · Manufacturer: Akron Pharma Inc. · FDA Application: 006203 · HUMAN OTC DRUG · FDA Label: Available
First Report: 201707 · Latest Report: 20200103
What Are the Most Common DIBUCAINE Side Effects?
All DIBUCAINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Insomnia | 30 | 33.3% | 0 | 1 |
| Malaise | 30 | 33.3% | 0 | 1 |
| Weight decreased | 30 | 33.3% | 0 | 1 |
| Angina pectoris | 29 | 32.2% | 0 | 0 |
| Appetite disorder | 29 | 32.2% | 0 | 0 |
| Asthma | 29 | 32.2% | 0 | 0 |
| Chest discomfort | 29 | 32.2% | 0 | 0 |
| Chest pain | 29 | 32.2% | 0 | 0 |
| Cough | 29 | 32.2% | 0 | 0 |
| Depressed mood | 29 | 32.2% | 0 | 0 |
| Depressive symptom | 29 | 32.2% | 0 | 0 |
| Dyspnoea | 29 | 32.2% | 0 | 0 |
| Dyspnoea exertional | 29 | 32.2% | 0 | 0 |
| Fall | 29 | 32.2% | 0 | 0 |
| Flank pain | 29 | 32.2% | 0 | 0 |
| Heart sounds | 29 | 32.2% | 0 | 0 |
| Influenza | 29 | 32.2% | 0 | 0 |
| Injury | 29 | 32.2% | 0 | 0 |
| Lower respiratory tract infection | 29 | 32.2% | 0 | 0 |
| Nasal congestion | 29 | 32.2% | 0 | 0 |
Who Reports DIBUCAINE Side Effects? Age & Gender Data
Gender: 87.0% female, 13.0% male. Average age: 64.0 years. Most reports from: US. View detailed demographics →
Is DIBUCAINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2017 | 1 | 0 | 1 |
| 2019 | 8 | 0 | 0 |
| 2020 | 1 | 0 | 0 |
What Is DIBUCAINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 36 |
| Haemorrhoids | 28 |
| Contusion | 7 |
| Infection | 7 |
| Skin abrasion | 6 |
Other Drugs in Same Class: Allergens [CS]
Official FDA Label for DIBUCAINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Use temporarily relieves pain and itching due to hemorrhoids and other anorectal disorders
Dosage & Administration
Directions Adults and children 12 years of age or older. If possible, clean the affected area by platting or blotting with an appropriate cleansing wipe, gently dry by patting or blotting with a tissue or a soft cloth before applying. Apply externally to the affected area up to 3 to 4 times daily. Children under 12 years of age. ask a doctor
Warnings
Warnings For external use only.
Allergy Alert
Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritaion, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor. Do not use in or near the eyes in children under 2 years of age When using this product do not use more than directed unless directed by a doctor. do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days If pregnant or breast-feeding ask a health care professional before use. Keep out of reach of children. If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
Active Ingredient
Drug Facts Active ingredient Purpose Dibucaine 1% Hemorrhoidal ointment
Inactive Ingredients
Inactive Ingredients Lanolin, Light Mineral Oil, Purified water, White Petrotalum