Solosec Side Effects Center

Last updated on RxList: 1/4/2022
Solosec Side Effects Center

What Is Solosec?

Solosec (secnidazole) oral granules is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in adult women.

What Are Side Effects of Solosec?

Common side effects of Solosec include:

Dosage for Solosec

The dose of Solosec is a single 2-gram packet of granules once orally, without regard to the timing of meals. Sprinkle entire contents of packet onto applesauce, yogurt or pudding and consume all of the mixture within 30 minutes without chewing or crunching the granules. A glass of water may be taken after the administration of Solosec to aid in swallowing. Solosec is not intended to be dissolved in any liquid.

What Drugs, Substances, or Supplements Interact with Solosec?

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

Solosec During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Solosec; it is unknown how it would affect a fetus. Breastfeeding is not recommended while taking Solosec. Discontinue breastfeeding for 96 hours after administration of Solosec.

The recommended dose of Tagitol V is one 20 mL bottle (8g barium sulfate) with each meal (breakfast, lunch and dinner) the day before the CT colonography examination. Total dose = 3 bottles. Tagitol V may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Tagitol V. Tagitol V is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Breastfeeding is not expected to result in exposure of the infant to the drug. Consult your doctor before breastfeeding.

Additional Information

Our Solosec (secnidazole) Oral Granules 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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Solosec Consumer Information

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

You may develop a vaginal yeast infection while taking secnidazole. Call your doctor at once if you have:

  • vaginal itching or burning;
  • redness or swelling; or
  • white or yellow vaginal discharge (may be odorless).

Common side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • headache; or
  • a bitter or metallic taste in your mouth.

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 Solosec (Secnidazole Oral Granules)

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Solosec 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.

The safety data described below reflect exposure to 589 patients, of whom 518 received a 2 g dose of SOLOSEC. SOLOSEC was evaluated in three clinical trials of patients diagnosed with bacterial vaginosis: two placebo-controlled trials (Trial 1 n=215, Trial 2 n=189) and one uncontrolled safety trial (Trial 3 n=321).

All patients received a single oral dose of study medication or placebo. Trial 1 evaluated a 1 g (this dose is not approved) dose (n=71) and a 2 g dose (n=72) of SOLOSEC. Trial 2 evaluated a 2 g dose (n=125). The population was female, aged 15 to 54 years. Patients in the placebo-controlled trials were primarily Black or African American (54%) or Caucasian (41%).

There were no deaths in the trials. Two patients in Trial 3 discontinued due to vulvovaginal candidiasis in the SOLOSEC-treated arm.

Most Common Adverse Reactions

Among 197 patients treated with a single 2 g dose of SOLOSEC in the two placebo-controlled trials, Trial 1 and 2, adverse reactions were reported by approximately 29% of patients. Table 1 displays the most common adverse reactions (≥ 2 % in SOLOSEC-treated patients) in these two trials.

Table 1: Adverse Reactions Occurring (≥ 2 % SOLOSEC-Treated Patients) in the Pooled Placebo-Controlled Trials 1 and 2 in Adult Women with Bacterial Vaginosis

Adverse Reaction SOLOSEC
N=197 n (%)
Placebo
N=136 n (%)
Vulvo-vaginal candidiasis 19 (9.6) 4 (2.9)
Headache 7 (3.6) 2 (1.5)
Nausea 7 (3.6) 1 (0.7)
Diarrhea 5 (2.5) 1 (0.7)
Abdominal pain 4 (2.0) 2 (1.5)
Vulvovaginal pruritus 4 (2.0) 2 (1.5)

Among the 321 patients in an uncontrolled trial, Trial 3, adverse reactions were reported in 30% of patients. Vulvovaginal candidiasis (8.4%), nausea (5.3%), vomiting (2.5%) and dysgeusia (3.4%) were the most common adverse reactions reported in this trial.

Post Marketing Experience

The following adverse reactions have been reported during use of SOLOSEC and other formulations of secnidazole 2 g outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache have been reported when SOLOSEC was taken concomitantly with alcohol. [see DOSAGE AND ADMINISTRATION, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

DRUG INTERACTIONS

Oral Contraceptives

There was no clinically significant drug interaction between secnidazole and the combination oral contraceptive, ethinyl estradiol plus norethindrone [see CLINICAL PHARMACOLOGY]. SOLOSEC can be co-administered with combination oral contraceptives (e.g., ethinyl estradiol plus norethindrone).

Alcohol

Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during SOLOSEC therapy and for 2 days after treatment is stopped.

Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache have been reported when SOLOSEC was taken concomitantly with alcohol. [see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS and CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Solosec (Secnidazole Oral Granules)

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

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