Suboxone Adverse Reactions

The most common treatment-related undesirable effects reported during clinical trials with Suboxone were those related to withdrawal symptoms (eg, abdominal pain, diarrhea, muscle aches, anxiety, sweating).
In the pivotal clinical study of Suboxone, 342 of 472 patients (72.5%) reported treatment-related adverse reactions. These reactions are listed as follows by system, organ class and frequency [very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000 to <1/100)].
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Treatment-Related Undesirable Effects Reported in the Pivotal Clinical Study of Suboxone (≥0.1% of Suboxone-Treated Patients):
Infections and Infestations: Common: Infection. Uncommon: Vaginitis.
Blood and Lymphatic System Disorders: Uncommon: Anemia, thrombocytopenia, leucopenia, lymphadenopathy, leukocytosis.
Immune System Disorders: Uncommon: Allergic reaction.
Metabolism and Nutrition Disorders: Common: Peripheral edema, decreased weight. Uncommon: Hyperglycemia, hyperlipemia, hypoglycemia.
Psychiatric Disorders: Common: Anxiety, nervousness, depression, decreased libido, abnormal thinking. Uncommon: Drug dependence, amnesia, hostility, speech disorder, depersonalization, abnormal dream, apathy, euphoria.
Nervous System Disorders: Very Common: Insomnia. Common: Somnolence, dizziness, paresthesia, hypertonia. Uncommon: Convulsion, agitation, tremor, hyperkinesia.
Eye Disorders: Common: Lacrimation disorder, amblyopia. Uncommon: Miosis, conjunctivitis.
Cardiac Disorders: Uncommon: Myocardial infarction, angina pectoris, palpitation, tachycardia, bradycardia.
Vascular Disorders: Common: Vasodilation, hypertension, migraine. Uncommon: Hypotension, heat stroke.
Respiratory, Thoracic and Mediastinal Disorders: Common: Rhinitis, pharyngitis, increased cough. Uncommon: Dyspnea, asthma, yawning.
Gastrointestinal Disorders: Very Common: Constipation, nausea. Common: Vomiting, dyspepsia, diarrhea, anorexia, flatulence. Uncommon: Ulcerative stomatitis, tongue discoloration.
Hepatobiliary Disorders: Common: Abnormal liver function.
Skin and Subcutaneous Tissue Disorders: Very Common: Sweating. Common: Rash, pruritus, urticaria. Uncommon: Exfoliative dermatitis, acne, skin nodule, alopecia, dry skin.
Musculoskeletal, Connective Tissue and Bone Disorders: Common: Arthralgia, myalgia, leg cramps. Uncommon: Arthritis.
Renal and Urinary Disorders: Common: Albuminuria, urine abnormality. Uncommon: Hematuria, kidney calculus, increased creatinine, urinary tract infection, dysuria, urinary retention.
Reproductive System and Breast Disorders: Uncommon: Impotence, amenorrhea, abnormal ejaculation, menorrhagia, metrorrhagia.
General Disorders: Very Common: Withdrawal syndrome, headache. Common: Asthenia, fever, flu syndrome, malaise, accidental injury, chills; chest, abdominal and back pain, pain.
Injury, Poisoning and Procedural Complications: Uncommon: Hypothermia.
Buprenorphine used alone for treatment of opioid dependency has been associated with the following symptoms (>1%): Constipation, headache, insomnia, asthenia, drowsiness, nausea and vomiting, fainting and dizziness, orthostatic hypotension and sweating. Other undesirable effects (<0.1%) have been reported in association with buprenorphine alone. These are respiratory depression (see Interactions and Precautions), hepatic necrosis and hepatitis (see Precautions), hallucinations, cases of bronchospasm, angioneurotic edema and anaphylactic shock.
In cases of IV misuse, local reactions, sometimes septic and potentially serious acute hepatitis, have been reported (see Precautions).
In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a withdrawal effect similar to that associated with naloxone.
Spontaneous abortion has been reported with both buprenorphine and buprenorphine-naloxone. It is not possible to establish a causal relationship since cases typically involve other drug use or risk factors for spontaneous abortion (see Use in pregnancy & lactation under Precautions).
A neonatal abstinence syndrome has been reported among newborns of women who have received buprenorphine during pregnancy. The syndrome may be milder and more protracted than that from short-acting full mu-opioid agonists. The nature of the syndrome may vary depending upon the mother's drug use history (see Use in pregnancy & lactation under Precautions).