Amzeeq

Last updated on RxList: 2/11/2021
Amzeeq Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Amzeeq?

Amzeeq (minocycline) is a tetracycline antibiotic used to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

What Are Side Effects of Amzeeq?

Side effects of Amzeeq include:

  • headache, and
  • application site reactions, including:
    • redness,
    • dryness,
    • skin discoloration,
    • peeling, and
    • itching

    Dosage for Amzeeq

    The dose of Amzeeq is a small amount of topical foam (e.g. a cherry-sized amount) rubbed into acne-affected parts of the face. Repeated as needed until all acne-affected parts of the face are treated. If acne is present on other parts of the body, apply additional amounts of topical foam to these areas. The topical foam should be applied at approximately the same time each day at least 1 hour before bedtime. Do not bathe, shower or swim for at least 1 hour after application of Amzeeq.

    Amzeeq In Children

    The safety and effectiveness of Amzeeq for acne lesions has not been established in pediatric patients less than 9 years of age. The use of oral tetracycline drugs such as Amzeeq during tooth development below the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and inhibition of bone growth.

    What Drugs, Substances, or Supplements Interact with Amzeeq?

    Amzeeq may interact with other medicines such as:

    Tell your doctor all medications and supplements you use.

    Amzeeq During Pregnancy and Breastfeeding

    Tell your doctor if you are pregnant or plan to become pregnant before using Amzeeq; it may harm a fetus. The use of drugs of the tetracycline class orally such as Amzeeq during tooth development may cause permanent discoloration of teeth. Breastfeeding is not recommended while using Amzeeq.

    Additional Information

    Our Amzeeq (minocycline) topical foam Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

    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.

    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.

QUESTION

Acne is the result of an allergy. See Answer
Amzeeq Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Serious side effects are unlikely when minocycline topical is applied to the skin, but can occur if the medicine is absorbed into your bloodstream.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
  • severe dizziness;
  • confusion, headache, vision problems, pain behind your eyes;
  • fever, swollen glands, itching, joint pain, or not feeling well;
  • discoloration of your skin, nails, eyes, mouth, gums, or teeth.
  • liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • lupus-like symptoms--muscle or joint pain, flu symptoms, chest pain, and a rash or patchy skin color that worsens in sunlight.

Minocycline can affect growth in children, especially if used long term.

Common side effects may include:

  • diarrhea; or
  • headache.

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.

Read the entire detailed patient monograph for Amzeeq (Minocycline Topical Foam)

SLIDESHOW

Skin Health: 15 Tips for Clear Skin See Slideshow
Amzeeq Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 3 randomized, double-blind, vehicle-controlled trials, subjects age 9 years and older applied AMZEEQ or vehicle once daily for 12 weeks. A total of 1,356 subjects were treated with AMZEEQ and 1,058 with vehicle. The majority of subjects were White (74%) and female (60%). Approximately 34% were Hispanic/Latino and 49% were younger than 18 years of age.

The most common adverse reaction reported by ≥1% of subjects treated with AMZEEQ and more frequently than in subjects treated with vehicle was headache, which was reported in 3% of subjects treated with AMZEEQ and 2% of subjects treated with vehicle.

Local tolerability evaluations were conducted at each study visit in the clinical trial by assessment of erythema, dryness, hyperpigmentation, skin peeling and itching. Table 1 presents the active assessment of the signs and symptoms of local facial tolerability at Week 12 in subjects treated with AMZEEQ.

Local tolerability signs and symptoms occurred in similar frequency and severity as subjects treated with the vehicle component of AMZEEQ.

Table 1: Facial Cutaneous Tolerability Assessment

Symptom/SeverityAMZEEQ, %
(N=1,377)
MildModerateSevere
Erythema14.21.50
Dryness6.80.60
Hyperpigmentation*12.42.80.1
Skin Peeling3.20.20
Itching5.10.80.1
*Hyperpigmentation was most frequently assessed as characteristic of inflammatory and post-inflammatory changes associated with acne.

In a 40-week open-label extension safety study (for a total of up to 52 weeks of treatment), frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.

Read the entire FDA prescribing information for Amzeeq (Minocycline Topical Foam)

© Amzeeq Patient Information is supplied by Cerner Multum, Inc. and Amzeeq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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