Subutex Side Effects

Doctors prescribe Subutex as drug replacement therapy intended to help patients overcome opioid dependence. Subutex contains buprenorphine, which mimics the effects of other opioids in a way that reduces withdrawal symptoms.

Subutex has a lower potential for abuse and are less dangerous in an overdose than is methadone, according to the FDA, so there are less restrictions on Subutex than methadone. Only approved clinics can dispense methadone, and these clinics are not accessible to all who need them. Any specially trained doctor can prescribe Subutex, and this product is safe enough for the patient to take home.

The FDA approved Subutex for use in October 2002 to address the growing problem of opioid dependence in the United States. Americans take more opioids than anyone else. Even though the U.S. represents only about 5 percent of global population, they use about 80 percent of the world's supply of opioids, according to the Institute of Addiction Medicine.

Side Effect Information

Subutex, like all drugs, can result in adverse reactions in some people. Many people experience no side effects or only minor side effects after using this drug. Most side effects are not serious and disappear after a few days of continued use at prescribed doses. Some adverse reactions are serious and require immediate medical attention.

Subutex is associated with a potential for abuse, physical dependence or addiction. The U.S. Drug Enforcement Agency, or DEA, classifies substances according to the potential for abuse. The DEA classifies this drug as a Schedule III narcotic. This means this drug carries a moderate potential for abuse and mental or physical dependence.

Drug dependence means you will feel flu-like withdrawal symptoms if you stop using it. Subutex addiction will cause you to crave and seek out Subutex when your supplies run low.

Withdrawal symptoms include:

  • Abdominal Cramps
  • Agitation
  • Anxiety
  • Blurred Vision
  • Insomnia
  • Restlessness
  • Sweating
  • Tremor
  • Vomiting

Adverse reactions associated with Subutex are similar to side effects associated other opioids. These side effects usually become less severe or stop altogether with continued use at proper doses. The most serious side effect is respiratory problems that may lead to stopped breathing, circulatory depression, dangerously low blood pressure and shock. Physicians should expect side effects in all patients and treat accordingly.

Respiratory depression is a dangerous breathing problem associated with opioid use. Respiratory depression is common and sometimes fatal. During respiratory depression, your lungs do not adequately exchange oxygen for carbon dioxide and other toxins. Symptoms of respiratory depression include slow or shallow breathing, unusual breathing patterns, gasping or wheezing, and a bluish tint around the eyes, mouth and fingertips. Seek help immediately if you suspect respiratory depression.

Allergic Reaction

Anyone can suffer an allergic reaction to this or any other drug. Seek help immediately if you suffer any symptoms of an allergic reaction after taking this drug - an allergic reaction is a serious, potentially fatal medical emergency. Bring the bottle of this drug with the rest of your medications to help physicians determine the cause of the reaction.

Symptoms of an allergic reaction include:

  • Difficulty Breathing
  • Hives
  • Itching
  • Rash
  • Swelling of the Mouth, Face, Lips or Tongue
  • Tightness in the Chest

Anaphylaxis is a severe form of an allergic reaction. Anaphylaxis usually appears within moments of exposure, but anaphylaxis may start as late as a half an hour or longer after exposure to this drug. Seek help immediately if you think you or someone you know is suffering anaphylaxis.

Anaphylaxis symptoms include hives, itching, flushed or pale skin. You may have a sensation of warmth during an episode of anaphylaxis. You might also feel like your throat is closing, your tongue is swelling up or that you have a lump in your throat. These sensations may lead to wheezing and trouble breathing. Your pulse may be weak and rapid; you may feel nauseated or even vomit. Some people become dizzy or faint. Others may express a feeling of impending doom.


Some people are hypersensitive to the effects of Subutex. Hypersensitivity symptoms include rash, hives, itching and swelling of the face.

Non-Serious Side Effects

The most commonly reported side effects associated with this drug are not serious and disappear eventually. Continue taking this drug but notify the prescribing physician if the following side effects become unbearable or if they do not go away on their own:

  • Chills
  • Constipation
  • Diarrhea
  • Dizziness
  • Drowsiness
  • Flushing
  • Headache
  • Nausea or Vomiting
  • Sleeplessness
  • Stomach Pain
  • Sweating
  • Weakness

Serious Side Effects

Some adverse reactions are serious and require immediate medical attention. Contact a doctor if you experience serious side effects, including:

  • Anxiety or Nervousness
  • Dark Urine
  • Mental or Mood Changes, especially Depression
  • Pale Stools
  • Slow or Shallow Breathing
  • Severe or Persistent Stomach Pain
  • Yellowing of the Skin or Eyes

By body system


Subutex may cause side effects that affect the body as a whole. About 6 percent of Subutex users report weakness. Others note chills, headache, infection, pain, abdominal pain and back pain while taking Subutex.

About 25 percent of Subutex users experience withdrawal symptoms when they stop taking this medication suddenly, especially for those who use Subutex for a long time. Additionally, the buprenorphine in Subutex may cause withdrawal symptoms in opioid dependent patients.

Nervous system

The buprenorphine component of Subutex works directly on the brain and nervous system to decrease withdrawal symptoms. As a result, Subutex may cause side effects involving the nervous system.

About 60 percent of people who take Subutex experience sedation. Some people report dizziness vertigo or headache. Rarely, Subutex causes confusion, weakness, fatigue, nervousness, slurred speech, and a prickly or burning sensation.

The buprenorphine in Subutex may increase cerebrospinal fluid pressure and cause changes in consciousness. Some Subutex consumers feel agitated or excessively sleepy after taking this medication. Others experience insomnia. Subutex may cause ringing in the ears, tremor, convulsions or coma.

Medicines that depress the central nervous system, or CNS, may increase the risk for side effects such as anxiety, depression, insomnia and elevated cerebrospinal fluid pressure. CNS depressants include opioid painkillers, general anesthetics, benzodiazepines, phenothiazines, tranquilizers, sedatives or hypnotics and alcohol.


Therapeutic doses of injectable or sublingual buprenorphine may cause respiratory system side effects. Intravenous misuse of Subutex may cause death, especially when combined with CNS depressants.
Hypoventilation may affect 1 percent to 5 percent of Subutex consumers. Less than 1 percent of people who take Subutex experience shortness of breath, stopped breathing or cyanosis, which is a bluish tint around the eyes, mouth and fingertips.

Patients who are dependent on opioids may suffer from a stuffy or runny nose while taking Subutex. Opioid-dependent individuals may suffer respiratory depression, especially after intravenous administration of Subutex.


Subutex side effects may affect the digestive tract. About 12 percent of Subutex consumers experience constipation; another 3 percent of users suffer from diarrhea. Nausea is a relatively common complaint, affecting about 15 percent of Subutex consumers. About 7 percent of consumers report vomiting. Buprenorphine may increase the pressure in the ducts between the liver and gall bladder.


Some individuals may be hypersensitive to Subutex. Side effects associated with Subutex hypersensitivity include rash, hives, itching, bronchospasm similar to an asthma attack, abnormal fluid between the body's cells and anaphylactic shock.


Babies born to women who took Subutex during pregnancy may experience withdrawal symptoms shortly after delivery.


Subutex may affect your heart. Less than 10 percent of opioid dependent patients who take Subutex experience cardiovascular side effects such as vasodilation, or widening of the arteries and veins. Buprenorphine may cause orthostatic hypotension, which is a sudden decrease in blood pressure when you sit or stand up suddenly.


Subutex is associated with endocrine side effects. About 14 percent of people who use Subutex under their tongue experience excessive sweating. Other forms of Subutex may not cause this side effect as often.


Subutex consumers may experience changes in their vision, including blurred vision, conjunctivitis, and pinpoint pupils. This medication may also cause amblyopia, commonly known as a "lazy eye."


Subutex use may rarely cause psychiatric side effects including euphoria, depersonalization, depression, dreaming, and psychosis in less than 1 percent of patients. Rarely, Subutex will cause dysphoria - the emotional opposite of euphoria. Some forms of buprenorphine may cause auditory and visual hallucinations.


Less than 1 percent of Subutex consumers report urinary retention.


Subutex use is rarely associated with dermatologic side effects have included itching and hives. The transdermal patch formula of Subutex may cause dermatologic side effects such as itching, puffiness, rash and irritation at the patch site.


Subutex use rarely causes side effects associated with the musculoskeletal system, including decrease muscle coordination.