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Zonalon Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Zonalon Overview - Patient Information: Side Effects
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: severe constipation, loss of coordination, ringing in the ears, persistent heartburn, mental/mood changes (e.g., agitation, confusion, depression), muscle weakness/spasms, numbness/tingling of the hands/feet, restlessness, decreased sexual ability/interest, trouble urinating, swelling of the hands/feet, weight gain.
Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), pain/redness/swelling of arms or legs, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.
Seek immediate medical attention if any of these rare but very serious side effects occur: slurred speech, fast/irregular heartbeat, vision changes, fainting, weakness on one side of the body, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Zonalon (Doxepin)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zonalon FDA Prescribing Information: Side Effects
Controlled Clinical Trials
Systemic Adverse Effects: In controlled clinical trials of patients treated with Zonalon (doxepin) Cream, the most common systemic adverse event reported was drowsiness. Drowsiness occurred in 71 of 330 (22%) of patients treated with Zonalon (doxepin) Cream compared to 7 of 334 (2%) of patients treated with vehicle cream. Drowsiness resulted in the premature discontinuation of the drug in approximately 5% of patients treated with Zonalon (doxepin) Cream in controlled clinical trials.
Local Site Adverse Effects: In controlled clinical trials of patients treated with Zonalon (doxepin) Cream, the most common local site adverse event reported was burning and/or stinging at the site of application. These occurred in 76 of 330 (23%) of patients treated with Zonalon (doxepin) Cream compared to 54 of 334 (16%) of patients treated with vehicle cream. Most of these reactions were categorized as "mild"; however, approximately 25% of patients who reported burning and/or stinging reported the reaction as "severe". Four patients treated with Zonalon (doxepin) Cream withdrew from the study because of the burning and/or stinging.
The table below presents the adverse events reported at an incidence of ≥ 1 % in either Zonalon (doxepin) or vehicle cream treatment groups during the trials:
|Burning /Stinging||76 (23.0%)||54 (16.2%)|
|Drowsiness||71 (21.5%)||7 (2.1%)|
|Dry Mouth1||32 (9.7%)||4 (1.2%)|
|Pruritus2||13 (3.9%)||20 (6.0%)|
|Fatigue/Tiredness||10 (3.0%)||5 (1.5%)|
|Exacerbated Eczema||10 (3.0%)||8 (2.4%)|
|Other Application Site Reaction3||10 (3.0%)||16 (4.8%)|
|Dizziness4||7 (2.1%)||3 (0.9%)|
|Mental Emotional Changes||6 (1.8%)||1 (0.3%)|
|Taste Perversion5||5 (1.5%)||1 (0.3%)|
|Edema||4 (1.2%)||1 (0.3%)|
|Headache||3 (0.9%)||14 (4.2%)|
|1 Includes reports of "dry lips", "dry
throat", and "thirst"
2Includes reports of "Pruritus Exacerbated"
3Includes report of "increased irritation at application site"
4Includes reports of "lightheadedness" and "dizziness/vertigo"
5Includes reports of "bitter taste" and "metallic taste in mouth"
Post Marketing Experience
Twenty-six cases of allergic contact dermatitis have been reported in patients using Zonalon (doxepin) Cream, twenty of which were documented by positive patch test to doxepin 5% cream.
Read the entire FDA prescribing information for Zonalon (Doxepin) »
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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