Symproic

Last updated on RxList: 5/3/2018
Symproic Side Effects Center

Last reviewed on RxList 5/3/2018

Symproic (naldemedine) tablets are an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Common side effects of Symproic include:

  • abdominal pain,
  • diarrhea,
  • nausea, and
  • vomiting.

In adults, the recommended dosage of Symproic is 0.2 mg once daily with or without food. Symproic may interact with rifampin, carbamazepine, phenytoin, St. John's wort, other opioid antagonists, fluconazole, atazanavir, aprepitant, diltiazem, erythromycin, itraconazole, ketoconazole, clarithromycin, ritonavir, saquinavir, amiodarone, captopril, cyclosporine, quercetin, quinidine, and verapamil. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Symproic. Babies born to mothers who have taken opioids such as Symproic while pregnant may experience withdrawal. It is unknown if Symproic passes into breast milk. Breastfeeding while using Symproic is not recommended. Withdrawal symptoms may occur if you suddenly stop taking Symproic.

Our Symproic (naldemedine) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Symproic Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor if you have symptoms of opioid withdrawal: sweating, fever, chills, warmth or tingling in your face, tremors, fast heartbeats, feeling anxious or agitated, yawning, runny nose, sneezing, watery eyes, stomach pain, nausea, vomiting, and diarrhea.

Stop using naldemedine and call your doctor at once if you have:

  • severe diarrhea; or
  • severe stomach pain that will not go away (this can lead to serious medical problems).

Common side effects may include:

  • nausea, vomiting, stomach pain; or
  • diarrhea.

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 Symproic (Naldemedine Tablets)

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Symproic Professional Information

SIDE EFFECTS

Serious and important adverse reactions described elsewhere in labeling include:

Clinical Trials 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 practice.

The data described below reflect exposure to SYMPROIC in 1163 patients in clinical trials, including 487 patients with exposures greater than six months and 203 patients with exposures of 12 months.

The following safety data are derived from three double-blind, placebo-controlled trials in patients with OIC and chronic non-cancer pain: two 12-week studies (Studies 1 and 2) and one 52-week study (Study 3) [see Clinical Studies].

In Studies 1 and 2, patients on laxatives were required to discontinue their use prior to study enrollment. All patients were restricted to bisacodyl rescue treatment during the study. In Study 3, approximately 60% of patients in both treatment groups were on a laxative regimen at baseline; patients were allowed to continue using their laxative regimen throughout the study duration. The safety profile of SYMPROIC relative to placebo was similar regardless of laxative use.

Tables 1 and 2 list common adverse reactions occurring in at least 2% of patients receiving SYMPROIC and at an incidence greater than placebo. Table 1 shows pooled 12-week data from Studies 1 and 2. Table 2 shows 12-week data from Study 3.

Table 1: Common Adverse Reactions* in Patients with OIC and Chronic Non-Cancer Pain (12-week data from Studies 1 and 2)

Adverse Reaction SYMPROIC 0.2 mg once daily
N=542
Placebo
N=546
Abdominal pain** 8% 2%
Diarrhea 7% 2%
Nausea 4% 2%
Gastroenteritis 2% 1%
*Adverse reactions occurring in at least 2% of patients receiving SYMPROIC and at an incidence greater than placebo
**Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, gastrointestinal pain.

Table 2: Common Adverse Reactions* in Patients with OIC and Chronic Non-Cancer Pain (12-week data from Study 3)

Adverse Reaction SYMPROIC 0.2 mg once daily
N=621
Placebo
N=619
Abdominal pain** 11% 5%
Diarrhea 7% 3%
Nausea 6% 5%
Vomiting 3% 2%
Gastroenteritis 3% 1%
*Adverse reactions occurring in at least 2% of patients receiving SYMPROIC and at an incidence greater than placebo
**Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper.

Adverse reactions up to 12 months in Study 3 are similar to those listed in Tables 1 and 2 (diarrhea: 11% vs. 5%, abdominal pain: 8% vs. 3%, and nausea: 8% vs. 6% for SYMPROIC and placebo, respectively).

Opioid Withdrawal

In Studies 1, 2 and 3, adverse reactions consistent with opioid withdrawal were based on investigator assessment and adjudicated based upon the occurrence of at least 3 adverse reactions potentially related to opioid withdrawal with onset of a constellation of those symptoms occurring on the same day or within one day of each other.

Adverse reactions of possible opioid withdrawal could include non-gastrointestinal (GI) symptoms (e.g., hyperhidrosis, hot flush or flushing, chills, tremor, tachycardia, anxiety, agitation, yawning, rhinorrhea, increased lacrimation, sneezing, feeling cold, and pyrexia), GI symptoms (e.g., vomiting, diarrhea, or abdominal pain), or both GI and non-GI symptoms.

In pooled Studies 1 and 2, the incidence of adverse reactions of opioid withdrawal was 1% (8/542) for SYMPROIC and 1% (3/546) for placebo. In Study 3 (52-week data), the incidence was 3% (20/621) for SYMPROIC and 1% (9/619) for placebo. Most SYMPROIC treated subjects experienced nearly equal incidence of GI only or both GI and non-GI symptoms.

Less Common Adverse Reactions

Two patients developed symptoms of hypersensitivity following a single dose of SYMPROIC. One patient reported bronchospasm and another rash.

Read the entire FDA prescribing information for Symproic (Naldemedine Tablets)

© Symproic Patient Information is supplied by Cerner Multum, Inc. and Symproic Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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