SAFETY TRIALS
Safety was studied in 3 trials involving over 1000 people treated with JOURNAVX.
JOURNAVX was generally well tolerated in clinical studies.
JOURNAVX was generally well tolerated in clinical studies.
Common side effects
In Trials 1 and 2, the most common side effects included itching (2.1%), muscle spasms (1.3%), increase in a certain blood enzyme called creatine phosphokinase (1.1%), and rash (1.1%)
No serious side effects
There were no serious side effects considered related to JOURNAVX
There were no serious side effects considered related to JOURNAVX
There were no serious side effects considered related to JOURNAVX
Talk to your doctor
Do not take JOURNAVX if you take certain medicines that are strong inhibitors of an enzyme called CYP3A. Ask your doctor if you're not sure
- JOURNAVX may temporarily reduce the chance of women becoming pregnant while on treatment. Talk to your doctor if you have concerns about becoming pregnant. If you are using contraceptives, you should continue to use contraceptives during treatment with JOURNAVX
Nausea or vomiting
The rates of nausea or vomiting experienced in Trials 1 and 2 were:
Tummy tuck trial: 20% with JOURNAVX, 25% with placebo, and 33% with hydrocodone/acetaminophen
Bunion removal trial: 9% with JOURNAVX, 12% with placebo, and 16% with hydrocodone/acetaminophen
The JOURNAVX safety profile is mainly based on the data from 2 randomized clinical trials, with supportive safety data from a third trial.
Consistent results across a variety of surgical procedures and nonsurgical conditions that cause acute pain
Consistent results across a variety of surgical procedures and nonsurgical conditions that cause acute pain
Consistent results across a variety of surgical procedures and nonsurgical conditions that cause acute pain
Trials 1 & 2
874 people with moderate-to-severe acute pain after a tummy tuck (Trial 1) and bunion removal (Trial 2)
Trial 3
An open-label trial in 256 people with moderate-to-severe acute pain in a variety of acute pain conditions and surgical procedures
In Trial 3, surgeries included:
musculoskeletal system-specific (orthopedic) surgery
plastic surgery
ear, nose, and throat (otorhinolaryngologic) surgery
general surgery
urinary/male reproductive system-specific (urologic) surgeries
As well as nonsurgical conditions such as:
joint pains (arthralgias)
limb pain
sprains/strains
Learn more
Questions about JOURNAVX?
What is JOURNAVX?
JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short-term (acute) pain.
It is not known if JOURNAVX is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take JOURNAVX if you take certain medicines that are strong inhibitors of an enzyme called CYP3A. Ask your healthcare provider if you are not sure.
Before taking JOURNAVX, tell your healthcare provider about all of your medical conditions, including if you:
What is JOURNAVX?
JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short-term (acute) pain.
It is not known if JOURNAVX is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take JOURNAVX if you take certain medicines that are strong inhibitors of an enzyme called CYP3A. Ask your healthcare provider if you are not sure.
Before taking JOURNAVX, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems. People with liver problems may have an increased risk of getting side effects from taking JOURNAVX
- are pregnant or plan to become pregnant. It is not known if JOURNAVX will harm your unborn baby. You and your healthcare provider should decide if you will take JOURNAVX while you are pregnant
- are breastfeeding or planning to breastfeed. It is not known if JOURNAVX passes into your breast milk. You and your healthcare provider should decide if you will take JOURNAVX while you are breastfeeding
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking JOURNAVX with certain other medicines may affect the way JOURNAVX and the other medicines work and may increase your risk of side effects. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Especially tell your healthcare provider if you take:
- hormonal birth control medicine (contraceptives) containing progestins other than levonorgestrel or norethindrone. If you take one of these contraceptives (progestins other than levonorgestrel or norethindrone), they may not work as well during treatment with JOURNAVX. You should also use nonhormonal contraceptives such as condoms or use other forms of hormonal birth control during treatment with JOURNAVX and for 28 days after you stop taking JOURNAVX
- medicines that are substrates of the CYP3A enzyme as they may become less effective during treatment with JOURNAVX. Your healthcare provider may need to adjust the dose of your medicine when starting or stopping JOURNAVX
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What should I avoid while taking JOURNAVX?
Do not take food or drink containing grapefruit during treatment with JOURNAVX.
What are the possible side effects of JOURNAVX?
The most common side effects for patients treated with JOURNAVX included itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.
JOURNAVX may temporarily reduce the chance of females becoming pregnant while on treatment. Talk to your healthcare provider if you have concerns about becoming pregnant. If you are using contraceptives, you should continue to use contraceptives during treatment with JOURNAVX.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of JOURNAVX.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information, for JOURNAVX.