Prudoxin Side Effects

Generic Name: doxepin topical

Medically reviewed by Drugs.com. Last updated on Aug 21, 2020.

Consumer
Professional

Note: This document contains side effect information about doxepin topical. Some of the dosage forms listed on this page may not apply to the brand name Prudoxin.

In Summary

Common side effects of Prudoxin include: application site reaction and drowsiness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to doxepin topical: topical cream

Side effects requiring immediate medical attention

Along with its needed effects, doxepin topical (the active ingredient contained in Prudoxin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking doxepin topical:

More common

Burning, crawling, or tingling sensation of the skin
swelling at the site of application
worsening of eczema and itching

Rare

Fever

Symptoms of overdose

Abdominal pain and swelling
blurring of vision
convulsions (seizures)
decreased awareness or responsiveness
difficulty in breathing
difficulty in passing urine
dizziness, fainting, or lightheadedness
drowsiness
enlarged pupils
excessive dryness of mouth
extremely high fever or body temperature
extremely low body temperature
fast heartbeat
increased or excessive unconscious or jerking movements
incurable constipation
irregular heartbeat
unconsciousness
vomiting
weak pulse

Side effects not requiring immediate medical attention

Some side effects of doxepin topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning and/or stinging at the site of application
changes in taste
dizziness
drowsiness
dryness and tightness of skin
dryness of mouth and/or lips
emotional changes
headache
thirst
unusual tiredness or weakness

Less common

Anxiety
irritation, tingling, scaling, and cracking of skin
nausea

For Healthcare Professionals

Applies to doxepin topical: topical cream

Local

Very common (10% or more): Burning/stinging (23%)

Common (1% to 10%): Other application site reaction

Frequency not reported: Irritation, tingling^[Ref]

Nervous system

Very common (10% or more): Drowsiness (up to 22%)

Common (1% to 10%): Dizziness, taste perversion

Uncommon (0.1% to 1%): Headache

Frequency not reported: Lightheadedness, taste bitter, taste metallic^[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth

Uncommon (0.1% to 1%): Numbness of tongue, nausea

Frequency not reported: Dry lips, dry throat, thirst, indigestion, vomiting, diarrhea, constipation^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, eczema exacerbated

Frequency not reported: Localized rash, pruritus exacerbated

Postmarketing reports: Allergic contact dermatitis^[Ref]

General

The most frequently reported adverse effects were drowsiness and burning/stinging at application site.^[Ref]

Genitourinary

Frequency not reported: Urinary retention^[Ref]

Hypersensitivity

Frequency not reported: Type IV hypersensitivity reaction^[Ref]

Ocular

Frequency not reported: Blurred vision, dry eyes^[Ref]

Other

Common (1% to 10%): Fatigue/tiredness, edema

Uncommon (0.1% to 1%): Fever

Frequency not reported: Vertigo^[Ref]

Psychiatric

Common (1% to 10%): Mental emotional changes

Uncommon (0.1% to 1%): Nervousness/anxiety^[Ref]

References

1. "Product Information. Zonalon (doxepin topical)." Bioglan Pharmaceutical Inc, Malvern, PA.

2. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."