Prudoxin Side Effects

Generic Name: doxepin topical

Note: This page contains side effects data for the generic drug doxepin topical. It is possible that some of the dosage forms included below 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

As well as its needed effects, doxepin topical (the active ingredient contained in Prudoxin) may cause unwanted side effects that require medical attention.

Severity: Moderate

If any of the following side effects occur while taking doxepin topical, check with your doctor or nurse as soon as possible:

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

• Fever

• 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

Minor Side Effects

Some doxepin topical side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

• 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

• 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]

It is possible that some side effects of Prudoxin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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