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Veregen

Last reviewed on RxList: 3/7/2017
Veregen Side Effects Center

Last reviewed on RxList 3/05/2016

Veregen (sinecatechins) Ointment is an herbal product made from green tea leaves used to treat external (on the outside of the body) genital and anal warts in adult patients. Veregen will not cure genital or anal warts, and will not prevent spreading the warts to other people through sexual intercourse or skin-to-skin contact. Veregen will not treat genital warts caused by the human papilloma virus (HPV). Common side effects of Veregen Ointment include mild skin reactions of the treated area such as itching, burning, pain, swelling, and redness.

Apply a 0.5 cm dose strand of the Veregen to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Wash hands before and after application of Veregen. Veregen may interact with other genital wart treatments you have used or are still using. Tell your doctor all medications and supplements you use. During pregnancy, Veregen should be used only when prescribed. It is unknown if Veregen passes into breast milk. Consult your doctor before breastfeeding.

Our Veregen (sinecatechins) Ointment 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.

Veregen Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Wash off the ointment with mild soap and water and call your doctor at once if you have any of these serious side effects:

  • severe redness, burning, or itching of treated skin;
  • swelling, blisters, sores, or skin changes where the medicine was applied;
  • hardening of the treated skin areas; or
  • bleeding of treated skin.

Less serious side effects may include mild stinging, itching, or irritation.

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 Veregen (Sinecatechins Ointment)

Veregen Professional Information

SIDE EFFECTS

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 Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks.

Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women.

In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.

Local and regional reactions (including adenopathy) occurring at > 1% in the treated groups are presented in Table 1.

Table 1: Local and Regional Adverse Reactions During Treatment (% Subjects)

  Veregen®
(N = 397)
Vehicle
(N = 207)
Erythema 70 32
Pruritus 69 45
Burning 67 31
Pain/discomfort 56 14
Erosion/Ulceration 49 10
Edema 45 11
Induration 35 11
Rash vesicular 20 6
Regional Lymphadenitis 3 1
Desquamation 5 < 1
Discharge 3 < 1
Bleeding 2 < 1
Reaction 2 0
Scar 1 0
Irritation 1 0
Rash 1 0

A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only.

Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle.

The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment.

Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia.

In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.

Read the entire FDA prescribing information for Veregen (Sinecatechins Ointment)

Related Resources for Veregen

Read the Veregen User Reviews »

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

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