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Subsys Side Effects

Drowsiness, nausea, and vomiting are the most common side effects reported with Subsys. Other possible reactions, occurring in at least 1 percent of people taking the drug, include fatigue, irritation under the tongue, and headaches. Although most side effects do not require medical treatment, notify your healthcare provider immediately if you experience any difficulty breathing, severe constipation, or hallucinations.

An Introduction to Subsys Side Effects

Just like any medicine, Subsys® (fentanyl sublingual spray) can cause side effects. However, not everyone who uses the medication will have problems. In fact, most people tolerate it quite well. If side effects do occur, in most cases, they are minor and either require no treatment or are treated easily by you or your healthcare provider.
(This article covers many, but not all, of the possible side effects with Subsys. Your healthcare provider can discuss a more complete list with you.)

Common Side Effects With Subsys

Subsys has been studied extensively in clinical trials. In these studies, the side effects that occurred in people given Subsys were carefully recorded. In all the studies, long-acting opioid narcotics were used in addition to Subsys. Therefore, it can be difficult to know whether the side effects observed were due to Subsys or the other opioid medications.
In clinical studies, the most common side effects included:
  • Nausea -- in up to 13 percent of people
  • Vomiting -- up to 10.3 percent
  • Drowsiness -- up to 9.5 percent
  • Dizziness -- up to 7.2 percent
  • Constipation -- up to 5 percent.
Other side effects that occurred in at least 1 percent of people given Subsys in clinical trials included:
  • A rapid heart rate (tachycardia)
  • Diarrhea
  • Mouth sores
  • Dry mouth
  • Irritation under the tongue
  • Fever
  • Swelling or water retention in the hands, feet, or lower legs
  • Fatigue
  • General weakness
  • Decreased appetite
  • Lethargy
  • Sedation
  • Shakiness (tremors)
  • Headache
  • Depression
  • Confusion
  • Hallucinations
  • Insomnia
  • Shortness of breath
  • Itching.
Warning: 10 Hidden Sources of Lactose

Subsys Medication Information

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