Natroba

Last updated on RxList: 5/10/2021
Natroba Side Effects Center

What Is Natroba?

Natroba (spinosad) Topical Suspension is a pediculicide used for the topical treatment of head lice infestation in patients six (6) months of age and older.

What Are Side Effects of Natroba?

Common side effects of Natroba include:

  • redness or irritation at the application site or in the eyes
  • application site dryness
  • application site skin peeling
  • hair loss, and
  • dry skin

Dosage for Natroba

Apply sufficient Natroba Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to a 120 mL (one bottle) dose to adequately cover scalp and hair. Leave on for 10 minutes, then thoroughly rinse off with warm water. If live lice are seen 7 days after the first treatment, a second treatment should be applied.

What Drugs, Substances, or Supplements Interact with Natroba?

Natroba may interact with other drugs. Tell your doctor all medications and supplements you use.

Natroba During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Natroba. Spinosad, the active ingredient in Natroba, does not pass into breast milk. However, Natroba contains benzyl alcohol, which may be systemically absorbed through the skin, and pass into breast milk. A nursing woman may choose to pump and discard breast milk for 8 hours after use to avoid infant ingestion of benzyl alcohol. Consult your doctor before breastfeeding.

Additional Information

Our Natroba (spinosad) Topical Suspension 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.

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Natroba Professional Information

SIDE EFFECTS

Clinical Studies Experience

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

Head Lice Infestations

NATROBA was studied in two randomized, active-controlled trials (N=552) in subjects with head lice; Table 1 presents selected adverse events, regardless of relationship to NATROBA, that occurred in at least 1% of subjects.

Table 1: Selected Adverse Events Occurring in at least 1% of Subjects with Head Lice Infestation

Signs Natroba (N=552) Permethrin 1% (N=457)
Application site erythema 17 (3%) 31(7%)
Ocular erythema 12 (2%) 15 (3%)
Application site irritation 5 (1%) 7 (2%)

Other less common reactions (less than 1% but more than 0.1%) were application site dryness, application site exfoliation, alopecia, and dry skin.

Scabies Infestations

NATROBA was studied in three randomized, double-blind, vehicle-controlled trials (Trial 1, Trial 2, and Trial 3) in 592 subjects with scabies infestation, of which 165 were ages 4-17 and 427 were adults. Subjects received a single application of NATROBA to the skin from the neck to the soles of the feet, which was washed off after a minimum of 6 hours. Table 2 presents adverse reactions related to NATROBA treatment that occurred in at least 1% of subjects.

Table 2: Adverse Reactions Occurring in at least 1% of Subjects with Scabies Infestation (Trials 1, 2 and 3)

Signs Natroba (N=322) Vehicle (N=270)
Application site irritation* 8 (3%) 0 (0%)
Dry skin 6 (2%) 0 (0%)
*Application site irritation also includes application site pain and burning sensation.

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Natroba (Spinosad Topical Suspension)

SLIDESHOW

Rosacea, Acne, Shingles, Covid-19 Rashes: Common Adult Skin Diseases See Slideshow

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

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