Bonjesta
- Generic Name: doxylamine succinate and pyridoxine hydrochloride
- Brand Name: Bonjesta Extended-Release Tablets
Bonjesta Extended-Release Tablets (Doxylamine Succinate and Pyridoxine Hydrochloride) side effects drug center
Bonjesta Side Effects Center
Bonjesta (doxylamine succinate and pyridoxine hydrochloride) is a fixed dose combination of an antihistamine and a Vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. The most common side effect of Bonjesta is drowsiness.
The dose of Bonjesta is one tablet at bedtime on Day 1. On Day 2, if symptoms are not adequately controlled, the dose of Bonjesta can be increased to one tablet in the morning and one tablet at bedtime. The maximum recommended dose of Bonjesta is two tablets daily, one in the morning and one at bedtime. Bonjesta may interact with alcohol, other medicines that can make you sleepy (sedatives, tranquilizers), and monoamine oxidase inhibitors (MAOIs). Tell your doctor all medications and supplements you use. Bonjesta is intended for use during pregnancy. Breastfeeding while using Bonjesta is not recommended.
Our Bonjesta (doxylamine succinate and pyridoxine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Bonjesta 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.
Common side effects may include:
- drowsiness.
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 Bonjesta (Doxylamine Succinate and Pyridoxine Hydrochloride)
Bonjesta Professional Information
SIDE EFFECTS
The following adverse reactions are discussed elsewhere in the labeling:
- Somnolence [see WARNINGS AND PRECAUTIONS]
- Falls or other accidents resulting from the effect of the combined use of BONJESTA with CNS depressants including alcohol [see WARNINGS AND PRECAUTIONS]
Clinical Trial 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 clinical practice.
The safety and efficacy of combination 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets compared to placebo was studied in a double-blind, randomized, multi-center trial in 261 women with nausea and vomiting of pregnancy. The mean gestational age at enrollment was 9.3 weeks, range 7 to 14 weeks gestation [see Clinical Studies]. Adverse reactions that occurred at an incidence ≥5 percent and exceeded the incidence for placebo are summarized in Table 1.
Table 1 - Number (Percent) of Women with ≥ 5 Percent Adverse Reactions in a 15-Day Placebo-
Controlled Trial of Combination 10 mg Doxylamine Succinate and 10 mg Pyridoxine Hydrochloride
Tablets (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence
than Placebo are Shown)
| Adverse Reaction | Combination 10 mg
Doxylamine Succinate
and 10 mg Pyridoxine
Hydrochloride Tablets (N = 133) |
Placebo (n = 128) |
| Somnolence | 19 (14.3%) | 15 (11.7%) |
Postmarketing Experience
The following adverse events, listed alphabetically, have been identified during post-approval use of the combination of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. 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.
Cardiac disorders: dyspnea, palpitation, tachycardia
Ear and labyrinth disorders: vertigo
Eye disorders: vision blurred, visual disturbances
Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, diarrhea
General disorders and administration site conditions: chest discomfort, fatigue, irritability, malaise
Immune system disorders: hypersensitivity
Nervous system disorders: dizziness, headache, migraines, paresthesia, psychomotor hyperactivity
Psychiatric disorders: anxiety, disorientation, insomnia, nightmares
Renal and urinary disorders: dysuria, urinary retention
Skin and subcutaneous tissue disorders: hyperhidrosis, pruritus, rash, rash maculopapular
Read the entire FDA prescribing information for Bonjesta (Doxylamine Succinate and Pyridoxine Hydrochloride)
© Bonjesta Patient Information is supplied by Cerner Multum, Inc. and Bonjesta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.