What are Suboxone side effects?
As with any drug, Suboxone does have a risk of side effects, ranging from mild and serious.
Serious side effects include:
- Breathing Problems (Respiratory and Central Nervous System Depression), Coma & Death
You are urged to contact your healthcare provider immediately if you:
- Experience slowed breathing
- Feel dizzy, faint or confused
Many reports of coma and death involved either injection of Suboxone or use of benzodiazepines, alcohol, buprenorphine, other CNS depressants in addition to Suboxone.
However, this was not always the case. So, be aware of this potential complication and contact your healthcare provider immediately if you notice breathing trouble.
Suboxone should be used with caution in those with compromised respiratory function, including those with:
- Chronic obstructive pulmonary disease (COPD)
- Cor pulmonale
- Decreased respiratory reserve
- Preexisting respiratory depression
Opioids can also cause sleep-related breathing disorders such as sleep-related hypoxemia and central sleep apnea.
- Risk of Overdose in Children & Opioid Naïve Patients
Children accidentally exposed to buprenorphine can experience severe and possibly fatal respiratory depression. Store Suboxone out of the sight and reach of children. Any unused medication should be destroyed appropriately.
Deaths have been reported in “opioid-naïve” individuals who received a two-milligram dose of buprenorphine intended to be used as an analgesic. Suboxone is not to be used as an analgesic.
- Risk of Abuse or Dependency
As with any opioid, Suboxone carries a risk of abuse or dependency. Your treatment program may slowly and carefully taper the use of Suboxone once treatment is complete to avoid long-term dependency.
- Elevation of Cerebrospinal Fluid Pressure
As with other opioids, buprenorphine may elevate the pressure of the fluid surrounding the brain the spinal cord. Elevated cerebrospinal fluid pressure (CSF) pressure can cause severe headaches and even vision loss. It is important to treat elevated CSF pressure in order to prevent permanent vision loss.
Because of this, Suboxone should be used with caution in those who have a head injury or intracranial lesions. It should also be used with caution if there are any circumstances in which cerebrospinal fluid pressure is increased.
- Elevation of Intracholedochal Pressure
Choledochal means “relating to, being, or occurring in the common bile duct,” according to the Merriam-Webster dictionary.
The liver produces bile that helps with the digestion and absorption of fat into the bloodstream. The bile is stored in the gallbladder until it is needed, when the common bile duct carries it from the gallbladder and liver duct intersection through the pancreas and into the small intestine’s duodenum.
As do certain other opioids, buprenorphine increases the pressure at which bile passes through this system.
If you have any biliary tract issues or problems, talk to your physician about whether Suboxone is right for you.
- Liver Problems (Hepatitis, Hepatic Events)
In some patients taking buprenorphine, there were reported cases of cytolytic hepatitis (a disease that causes liver cell destruction) as well as hepatitis with jaundice.
The severity of liver problems ranged from a mild elevation in liver enzymes (transaminases) that cause no symptoms and eventually pass, to hepatic necrosis (death of liver cells), liver failure and death.
There have also been reports of hepatorenal syndrome (progressive liver failure) and hepatic encephalopathy (temporary worsening in brain function that occurs with advanced liver disease).
In many of the cases where these adverse events occurred there was either:
- A pre-existing liver enzyme abnormality
- Hepatitis B or C
- Use of other drugs that are potentially hepatotoxic along with Suboxone
- A continuation of drug injection after starting Suboxone
These factors may have contributed or caused the adverse outcomes. However, in some cases, there was insufficient data to determine the cause, and it is possible that buprenorphine was the culprit.
Therefore, you will need to be watchful for the following symptoms. If you notice any of the following, call your healthcare provider immediately:
- The white of your eyes or your skin turning yellow (jaundice)
- Dark-colored urine
- Light-colored stools
- Loss of appetite
- Stomach pain or nausea
Suboxone prescribing instructions recommend a liver function test be performed prior to treatment as well as monitoring during treatment on a periodic basis. If a hepatic event is suspected during treatment, further evaluation is recommended.
- Hypersensitivity/Allergic Reaction
If you are allergic to either buprenorphine or naloxone, you should not use Suboxone. Reported allergic reactions include bronchospasm (tightening of the muscles lining the airways) angioneurotic edema (swelling of the tissue under the skin), and anaphylactic shock.
Seek immediate care if you experience any of the following:
- Facial swelling
- Loss of blood pressure
- Loss of consciousness
Inform your healthcare provider if you experience the following:
- Runny nose/watery eyes
- Diarrhea and/or vomiting
- Muscle aches
- Feeling hotter or colder than normal
If you abruptly stop taking Suboxone or taper off of it too quickly, you could experience withdrawal symptoms. Also, if Suboxone is abused or if it is initiated too soon after your last opioid use, it can bring on precipitated withdrawal.
- Decrease in your Blood Pressure (Orthostatic Hypotension)
This may make you feel dizzy when getting up from a sitting or lying down position. Let your physician know about any dizziness you experience.
Adrenal insufficiency is a condition affecting your adrenal glands that causes your body to not make enough of certain hormones such as cortisol and aldosterone.
Opioid use has been associated adrenal insufficiency. It occurs more often when opioids are taken for more than a month.
Adrenal insufficiency symptoms can include:
- Low blood pressure
Talk with your physician about any symptoms you develop while taking Suboxone. If they suspect adrenal insufficiency, it can be tested and treated.
Serotonin is a naturally occurring chemical that aids in brain and nerve cell function. However, when too much accumulates in the body as it does when opioids are used along with serotonergic drugs, it can be life-threatening.
Serotonergic drugs include SSRIs, SNRIs, TCAs, monoamine oxidase inhibitors (MAOIs), antidepressants, trazodone, nefazodone, mirtazapine. Use of these drugs with opioids has resulted in cases of serotonin syndrome.
Symptoms of serotonin syndrome range from mild to serious:
- Goose bumps
- Rapid or Irregular heart rate
- High blood pressure
- Muscle rigidity, twitching or muscle coordination loss
Tell your healthcare practitioner about any symptoms you experience.
Androgen deficiency (lower levels of sex hormones such as testosterone). This can lead to a range of adverse symptoms, from fatigue and depression to shrinkage of sex organs. Chronic opioid use has been associated with androgen deficiency.
- Effects in Acute Abdominal Conditions
Buprenorphine, just like other opioids, may make it harder to diagnose acute abdominal conditions.
Anaphylaxis is a severe allergic reaction that can be life-threatening. Cases of anaphylaxis have been reported with exposure to ingredients that are contained in Suboxone film.
- Neonatal Withdrawal Syndrome
Prolonged use of opioids while pregnant can cause neonatal opioid withdrawal syndrome (NOWS) in infants.
If you are pregnant or are planning on becoming pregnant, discuss this with your physician or healthcare provider prior to beginning Suboxone treatment.
- Impaired Ability to Drive or Operate Machinery
Your ability to drive or operate machinery may be impaired while taking Suboxone. This is especially true during the induction phase where doses are being adjusted. Use caution until you are reasonably certain the Suboxone does not affect your ability to drive or operate machinery.
Other side effects of Suboxone and/or active ingredient that emerged in clinical trials and after it was on the market include:
- Numbness of the mouth (Oral Hypoesthesia)
- Burning sensation of the mouth, tongue or lips (Glossodynia)
- Blistering and ulceration of the tongue
- Swollen, Inflamed tongue (Glossitis)
- Inflamed, Sore mouth (Stomatitis)
- Oral lesions (Oral Mucosal Erythema)
- Feeling intoxicated (Intoxication)
- Inability to pay attention (Attention Disturbance)
- Irregular heartbeat (Palpitations)
- Excessive sweating (Hyperhidrosis)
- Blurred vision
- Peripheral edema
One of the clinical trials for Suboxone was a four-week study comparing it with Subutex. Researchers found the side effects of the two drugs to be similar. Those occurring in at least five percent of patients taking Suboxone 16 mg buprenorphine/4 mg naxolone sublingual tablets were:
- Headache – 36.4%
- Withdrawal syndrome – 25.2%
- Pain – 22.4%
- Nausea – 15%
- Insomnia – 14%
- Sweating – 14%
- Constipation – 12.1%
- Abdomen pain – 11.2%
- Decreased blood pressure (Vasodilation) – 9.3%
- Vomiting – 7.5%
- Weakness/lack of energy (Asthenia) – 6.5%
- Chills – 7.5%
- Infection – 5.6%
- Inflammation of the nasal membrane (Rhinitis) – 4.7%
- Back pain – 3.7%
- Diarrhea – 3.7%
It should be noted that some of these incidences were lower than those experienced in the placebo group, such as back pain (3.7% in the Suboxone group, 11.2% in the placebo group), infection (5.6% versus 6.5%), diarrhea (3.7% versus 15%), insomnia (14% versus 15.9%) and rhinitis (4.7% versus 13.1%).
During induction, the most common side effect was restlessness. The following other side effects were observed during induction:
- Goosebumps (Piloerection)
- Stomach discomfort
- Cold sweat
- Joint pain (Arthralgia)
- Increased tearing (Lacrimation)
Long-term side effects of Suboxone include potential problems with fertility in both males and females.
For more information, see the full prescribing information for Suboxone or speak with your healthcare professional.